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How to run BPR processes with R4BP 3 in Member State
competent authorities Release date: December 2014 1
Biocides
How to run BPR processes with R4BP 3 in Member State competent authorities
MANUAL for authority users
How to run BPR processes with R4BP 3 in Member State competent authorities
Reference: ECHA-14-B-30
Cat number: ED-07-14-027-EN-N
ISBN: 978-92-9247-090-6
DOI: 10.2823/18984
Publ. date: December 2014
Language: EN
© European Chemicals Agency, 2014
Cover page © European Chemicals Agency
Legal notice:
Neither the European Chemicals Agency nor any person acting on behalf of the European
Chemicals Agency is responsible for the use which might be made of the following information.
A wealth of additional information on the European Chemicals Agency is available on the
Internet. It can be accessed through the ECHA website (http://echa.europa.eu).
Reproduction is authorised provided the source is fully acknowledged in the form
“Source: European Chemicals Agency, http://echa.europa.eu/”, and provided written
notification is given to the ECHA Communications Unit ([email protected]).
If you have questions or comments in relation to this document please send them (quote the
reference and issue date) using the information request form. The information request form is
accessible from the Contact ECHA page at: http://echa.europa.eu/contact
European Chemicals Agency
Mailing address: P.O. Box 400, FI-00121 Helsinki, Finland Visiting address: Annankatu 10, Helsinki, Finland
How to run BPR processes with R4BP 3 in Member State
competent authorities Release date: December 2014 3
Version Changes Date
Version 1.0 First version. August 2013
Version 2.0
Version 3.0 Version 4.0
The manual is updated to incorporate the changes implemented in R4BP 3.1. Six new processes are added, new steps described and streamlined in the process chapters, workflow are inserted in the process chapters to visualise each single process. New enhanced case event history page has been added. Management of asset document functionality has been added.
The manual is updated to incorporate the changes implemented in R4BP 3.1.2. Four new processes are added: provisional authorisations, renewal of mutual recognition, and new active substance under BPD. The manual is updated to incorporate the changes implemented
in R4BP 3.2. As many as 23 new processes are added. The sequence of the chapters has been aligned with that of the industry submission manuals. To avoid repetitions the explanation of the legal framework of each case type (processes) has been referred to the relevant chapters of the BPR practical guide. In the same way the description of the applications
requirements is delegated, when relevant, to the respective submission manuals via dedicated links. To further reduce the length of the document the workflows’ charts have been summarised in one table and are not anymore displayed at the beginning of each chapter.
April 2014
June 2014 December 2014
Table of Contents
1. Introduction ........................................................................................................... 6
2. What is R4BP 3? ................................................................................................... 12
3. Working in R4BP 3 ................................................................................................ 13
4. AS-APP Active substance approval ....................................................................... 42
5. AS-EVA Active substance evaluation under Directive 98/8/EC ............................. 43
6. AS-NAS New active substance evaluation under Directive 98/8/EC ..................... 45
7. AS-RNL Renewal of the approval of an active substance ...................................... 45
8. AN-APP (1-5) Amendment of Annex I .................................................................. 46
9. AN-APP (6) Amendment of Annex I ...................................................................... 47
10. NA-APP National authorisation ........................................................................... 48
11. NA-APP (WA) Provisional national authorisation Article 55(2) ........................... 50
12. NA-RNL Renewal of National authorisation ........................................................ 52
13. NA-RNL Renewal of National authorisation subject to mutual recognition ......... 54
14. NA-MRP Mutual recognition in parallel ............................................................... 59
15. NA-MRS Mutual recognition in sequence ............................................................ 62
16. NA-BBP, NA-BBS National authorisation of the same biocidal product ............... 65
17. NA-ADC National authorisation - Administrative change on request ................... 67
18. NA-TRS Transfer of a national authorisation ...................................................... 69
19. NA-MRG Merge of product authorisations in one product family ......................... 70
20. NA-MIC National authorisation - Minor change on request ................................. 71
21. NA-MAC National authorisation - Major change on request ................................ 74
22. NA-AAT Amendment of National authorisation ................................................... 77
23. NA-CAT Cancellation of national authorisation ................................................... 78
24. ET-NOT Notification for experiment or test ......................................................... 79
25. NA-NPF Notification of product in product family for national authorisation ...... 80
26. Settlement of disagreements (n/a) .................................................................... 81
27. NE-NOT Notification of an unexpected or adverse effect national authorisation . 82
28. PP-APP Parallel Trade ......................................................................................... 83
29. PP-AAT Amendment of parallel trade permit ...................................................... 83
30. PP-CAT Cancellation of parallel trade permit ...................................................... 84
31. SA-APP National authorisation – simplified procedure ....................................... 85
32. SA-BBS Simplified authorisation of the same biocidal product (authorised) ....... 86
33. SA-BBP Simplified authorisation of the same biocidal product (pending) ........... 86
34. SA-CAT Cancellation of simplified authorisation ................................................. 87
35. SA-AAT Amendment of simplified authorisation ................................................. 87
36. SA-ADC Simplified authorisation administrative change on request ................... 88
37. SA-TRS Transfer of a simplified authorisation .................................................... 89
38. SA-MIC Simplified authorisation minor change on request ................................. 89
39. SA-MAC Simplified authorisation major change on request ................................ 90
40. SA-NPF Notification of product in product family for simplified authorisation .... 91
41. SE-NOT Notification of unexpected or adverse effect for SA ............................... 92
42. SN-NOT Notification for placing on the market - simplified procedure ................ 92
43. UA-APP Union authorisation ............................................................................... 93
44. UA-APP (WA) Provisional Union authorisation ................................................... 94
Table of Figures Figure 1: R4BP 3 Login screen ................................................................................................. 13
Figure 2: IUCLID-BPR login screen .......................................................................................... 14
Figure 3: R4BP 3 homepage ..................................................................................................... 15
Figure 4: Searching for a task .................................................................................................. 16
Figure 5: ‘Tasks list’ ................................................................................................................. 17
Figure 6: Searching for a message ........................................................................................... 18
Figure 7: Searching for a case ................................................................................................. 19
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Figure 8: ‘Case list’ .................................................................................................................. 19
Figure 9: “Case details page” ................................................................................................... 21
Figure 10: Case inventory history page ................................................................................... 22
Figure 11: Searching for an asset ............................................................................................ 22
Figure 12: ‘Assets list’ ............................................................................................................. 23
Figure 13: ‘Asset details’ page ................................................................................................. 23
Figure 14: ‘TASKS’ page ........................................................................................................... 24
Figure 15: ‘MSCA accept’ page ................................................................................................. 25
Figure 16: ‘MSCA accept’ page, release the task function. ....................................................... 25
Figure 17: ‘MSCA accept’ page 1/2 .......................................................................................... 26
Figure 18: ‘MSCA accept’ page 2/2 .......................................................................................... 27
Figure 19: ‘Complete task confirmation’ page .......................................................................... 27
Figure 20: ‘Validate’ page of the “Validate” task. .................................................................... 28
Figure 21: ‘Evaluate’ page of the “Evaluate” task. ................................................................... 28
Figure 22:‘Evaluate & Decide’ page of the “Evaluate & Decide” task. ...................................... 29
Figure 23: Management of SPC files......................................................................................... 29
Figure 24: Management of asset document. ............................................................................ 29
Figure 25: ‘Provide your decision page’1/2 ............................................................................. 32
Figure 26: ‘Provide your decision page’2/2 ............................................................................. 33
Figure 27: Select the Topic’ page ............................................................................................. 34
Figure 28: Case details – Financial management tab’ page ...................................................... 36
Figure 29: ‘Financial information’ page .................................................................................... 36
Figure 30: ‘Upload new invoice’ page ...................................................................................... 37
Figure 31: ‘Upload new invoice’ page, select language ............................................................ 37
Figure 32: ‘Financial information - send’ page ......................................................................... 37
Figure 33: ‘Confirmation message’ page .................................................................................. 38
Figure 34: ‘Financial information – handle invoices – Fee paid’ page ...................................... 38
Figure 35: ‘Financial information – handle invoices – unpaid’ page ......................................... 39
Figure 36: Tracking the reference case or asset of a same biocidal product ............................ 66
Table of Tables Table 1: Example of process flow chart.................................................................................... 10
Table 2: Case type and SPC correlation table ........................................................................... 30
1. Introduction
1.1. Objective
This manual addresses users working in the competent authorities of the Member States of
the European Union as well as of Iceland, Norway, Liechtenstein and Switzerland where
appropriate.
The purpose of this manual is to describe the key steps authority users need to perform
under the Biocidal Products Regulation (BPR). It describes the main steps in the IT-tool
“Register for Biocidal Products (R4BP 3)”, communication and exchange of information with
other Member State competent authorities, the European Chemicals Agency (ECHA) or the
Commission. In addition this manual contains information on how to access the IUCLID 5
database. The IUCLID 5 format is used by applicants for submitting and storing the scientific
and technical data1 and can be used by Member States to create annotations or compare
dossiers.
This manual focusses on the submission and evaluation process of applications and
submissions under the BPR. The manual will progressively be adapted to cover all the
processes foreseen by the BPR.
1.2. Conventions and terminology
The following text conventions are used throughout this manual:
AS Active substance
MR renewals
Regulation Commission Delegated Regulation (EU) No 492/2014 of 7 March 2014
supplementing Regulation (EU) No 528/2012 of the European
Parliament and of the Council as regards the rules for the renewal of
authorisations of biocidal products subject to mutual recognition
BP Biocidal product
BPC Biocidal Products Committee
BPR Regulation (EU) No 528/2012 of the European Parliament and of the
Council of 22 May 2012 concerning the making available on the
market and use of biocidal products
CAR Competent authority report (for active substance)
cMS Concerned Member State
eCA Evaluating (Member State) competent authority
ECHA European Chemicals Agency
1 Guidance and video tutorials on IUCLID 5 topics are available on the ECHA website here: http://echa.europa.eu/web/guest/support/dossier-submission-tools/r4bp
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IUCLID 5 International Uniform Chemical Information Database, version 5
.i5z File format of IUCLID files
MSCA Member State competent authority
PAR Product assessment report
R4BP 3 Register for Biocidal Products, version 3, established and maintained
by ECHA
rMS Reference Member State (for the process national authorisation
receiving Member State)
PT Product-type
SPC Summary of biocidal product characteristics
UUID
BRC
EAA
MSCA
initiated
Unique Universal Identifier (it can be related to Company, Dossier)
Business Rules Confirmation
ECHA Accept
MSCA initiated
MAA
VAL
MEV
EVL
OPN
MSCA Accept
Validate
MSCA Evaluate
Evaluate and decide
ECHA Opinion
DEC COM Decision
WA Work around. Another case type is used to cover the process. A
supporting document helps to identify the correct process.
The following icons are used throughout this manual:
Useful information, guidance, assistance
Very important note
1.3. Definitions and concepts
Applicant A legal entity in whose name an application is submitted
under the BPR, e.g. an entity applying for the approval of an
active substance (AS) or a prospective authorisation holder.
Application The formal request to an authority made by the applicant
and evaluated by an authority.
Asset In the R4BP 3 context, an asset is a regulatory decision on
an application (with a unique asset number) related to either
an AS (e.g. a decision on technical equivalence or a decision
on the compliance with Article 95) or a biocidal product (BP)
(e.g. a national authorisation or a Union authorisation), or a
notification (e.g. notification of experiment or test or
inquiry).
Asset owner The legal entity in whose name an application or notification
is made under the BPR (e.g. the applicant for product
authorisation, parallel trade permit, decision on technical
equivalence).
Authorisation holder The person established within the Union who is responsible
for the placing on the market of a BP in a particular Member
State or in the Union, and specified in the regulatory
decision.
Authority users The authority users are comprised of ECHA, the Member
State competent authorities (MSCA) and the Commission.
Case In R4BP 3, a case relates to an application or notification
submitted by an industry user that follows a series of tasks
to complete a pre-defined workflow. A unique case number
identifies a case in R4BP 3. It includes all the steps in the
application process, which lead to the creation, or the
update, of an asset (the regulatory decision). The case
number helps to manage and view the progress of a
submission by both industry and authority users.
Case owner The legal entity which creates the case and is following it
through its processing, paying any invoices, providing any
additional information requested by authorities, commenting
on any draft evaluation reports or opinions, etc. The case
owner is either the asset owner or the representative of the
asset owner acting on behalf of the asset owner.
Event An event is a step whereby information is submitted that is
needed in the handling / processing of an application.
Examples include the submission of an application, the
submission of additional information on the request of the
authorities, fee payment, and the communication of a
decision.
Industry user The legal entity user registered in R4BP 3.
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IVA cycle IVA is the acronym for initiator, verifier and authoriser users.
An IVA cycle is a quality tool using the two to three pair of
eyes principle. The first person initiates a task, a second
person verifies the correctness of the task and the third
person authorises the execution of the task. For MSCAs
currently only the I cycle is implemented in R4BP 3.
Task A working item created by R4BP 3 and assigned to a specific
user group (industry or authority users). A task is created in
order to complete certain actions (e.g. request for additional
information) that are required from the user. These requests
are completed through task items within a defined time
period. The task is identified by the task name and is related
to a particular case number.
1.4. Structure of the document
The structure of the document is as follows: chapters 2 and 3 provide a general introduction
to the IT-tool R4BP 3 and its main functions, whereas chapters 4 to 44 describe, using a
stepwise approach, the BPR processes relevant to Member States. An overview of all R4BP 3
processes in which MSCA are involved is given in the table of content of this manual.
Each chapter related to a BPR process is divided in subchapters:
1. The “Introduction” subchapter provides a link to the relevant chapter(s) of the
Practical Guide where an explanation of the regulatory frame is given.
2. It is followed by the description of the “workflow” types (e.g. BRC > MAA > VAL >
EVL). The dark blue colour highlights the tasks under MSCA responsibility. They will
be explained in details in each subchapter “Steps to be followed by MSCAs”.
3. The “Application requirements” subchapter describes, sometimes also referring to
the industry submission manuals, what it is required in a case type (application or
notification) to enable the authority users to correctly receive it.
4. The subchapter “Steps to be followed by MSCAs” explains (only) the tasks expected
to be performed by the authority users in a MSCA2. For information on the tasks
performed by the applicant please refer to the relevant industry submission manuals
webpage.
5. Eventually, the subchapter “Supporting documents” lists templates provided by
ECHA to facilitate the MSCA’s work. Please note that this subchapter is only present
when supporting documents are required.
Table 1: summarises the case types codes, the workflow types and the related workflow
charts. The table of content of this manual explains the case type codes.
2 In this manual, authority users are users in an MSCA unless otherwise specified.
Table 1: Example of process flow chart
Case types Workflow types Workflow charts
NA-MRP NA-MRS
BRC > EAA > MAA > VAL > EVL
NA-APP NA-RNL NA-MIC NA-MAC NA-BBS NA-BBP SA-BBS SA-BBP
BRC > MAA > VAL > EVL
NA-ADC
NA-TRS NA-MRG
PP-APP SA-APP SA-MAC SA-MIC
BRC > MAA > EVL
NA-NPF ET-NOT SN-NOT SA-NPF SA-ADC SA-TRS SE-NOT
NE-NOT
BRC > EVL
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NA-AAT
NA-CAT
PP-AAT PP-CAT SA-AAT SA-CAT
MSCA initiated > EVL
AS-APP AS-RNL AS-EVA AS-NAS AN-APP (6)
UA-APP
BRC > EAA > VAL > MEV > OPN > DEC
AN-APP (1-5) BRC > EAA > MAA > MEV > OPN > DEC
2. What is R4BP 3?
R4BP 3 is an information system established and maintained by ECHA with the aim of
ensuring that the BPR processes are managed by appropriate IT applications, to meet the
requirements set out in the BPR. R4BP 3 provides appropriate functions that allow the
exchange of information between industry and authority users (ECHA, MSCAs and
Commission). R4BP 3 shall be used to record and communicate the decisions on
authorisations taken in the MSCA and at Union level (see Article 71(6) of the BPR).
R4BP 3 consists of two main independent applications, one for all the authority users and
one for industry users.
2.1 Authority application
The R4BP 3 authority application is dedicated for authority users to support their day-to-
day work in the regulatory processes. With input from authority users, the system
processes the applications submitted by industry users and facilitates interaction between
authority users.
The processes relevant to MSCA authority users are described in the following chapters.
2.2 Industry application
The R4BP 3 industry application is dedicated for industry users to submit applications,
notifications and information for all processes under the BPR. R4BP 3 also provides the
possibility of monitoring applications, notifications, and asset portfolios. Through the
industry interface, industry users are able to log in, submit applications, review data,
download documents such as invoices, view the status of submitted applications and
payments, and receive notifications from the authorities and complete tasks assigned to
them by authority users.
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3. Working in R4BP 3
3.1 User types in R4BP 3
As of R4BP 3.2 significant changes have taken place in the MSCA user management. Roles
have been simplified and all users have access to the same functionalities in R4BP 3.
3.2 How to access R4BP 3 and ECHA’s IUCLID 5 database for Biocides as an authority user
Detailed technical instructions on how to login to ECHA Remote Access Portal and Biocide
IT systems (R4BP 3 and IUCLID 5) as an authority user, are available on CIRCABC IG
‘MSCA User Administrators’ IT support’ at:
https://circabc.europa.eu/w/browse/21143482-68ca-4a30-8b06-4bb8b33547f1
Access to CIRCABC is open to all User Administrators and End-Users (of ECHA’s IT
systems) from all Member State competent authorities, mandated national
authorities, designated national authorities and European Commission. To request
access, use the MSCA IT Support contact form
https://comments.echa.europa.eu/comments_cms/MSCA_ITsupport_form.aspx and
provide us with your ECAS account
Upon successful logon into ECHA Remote Access Portal, the users would visualise the login
screens of R4BP 3 and IUCLID-for-Biocides database (IUCLID-BPR) as shown in Figure 1
and Figure 2 below.
Figure 1: R4BP 3 Login screen
Figure 2: IUCLID-BPR login screen
Further information on how to use IUCLID 5 is available in the separate manual for
authorities: ‘Biocides IUCLID dossiers content, comparison and annotations’ available also
CIRCABC IG ‘MSCA User Administrators’ IT support’ at:
https://circabc.europa.eu/w/browse/2eea9eb7-414f-4d1f-aeec-63b98dc6b920
3.3 R4BP 3 homepage
The R4BP 3 homepage is displayed once you have logged in to R4BP 3. The homepage
contains various features (Figure 3):
1. Clicking on the ECHA logo in the top left corner, directs you back to the homepage
from any other page. This feature is available on all of the R4BP 3 pages.
2. The taskbar at the top of the page next to the ECHA label contains four main tabs –
‘TASKS’, ‘MESSAGES’, ‘CASES’ and ‘ASSETS’. Each tab allows you to perform certain
actions or view information related to all of the applications submitted. This taskbar
is available in all of the R4BP 3 pages. More information on each of the tabs is
provided in the following sections of this chapter.
3. The ‘User ID’ is displayed at the top left corner below the ECHA label, as welcome,
<’user ID’>. This information is displayed in all of the R4BP 3 pages.
4. The log-out button ( button) is available at the top right corner. This feature is
available in all of the R4BP 3 pages.
5. A list of the oldest 10 tasks ‘claimed’ by the user is displayed sorted by submission
date.
6. A list of group tasks is displayed. The system shows 10 ‘All open tasks’ (claimed and
unclaimed), sorted by submission date (oldest on top). Group tasks are all tasks that
are sent to the MSCA, i.e. EVL (evaluation) task, and REC (reply communication)
task.
7. Only the 10 latest messages are displayed. Red messages indicate that the message
has not been read yet. The messages are sorted in reversed chronological order by
the receiving date. New unread messages and messages that have been read are
displayed accordingly in the list.
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8. Useful explanations can be found on the right hand side, in the yellow ‘Good to know’
box.
Figure 3: R4BP 3 homepage
3.4 Tasks
A task is a working item that is created automatically during the application process by
R4BP 3 or by an authority user when requesting further information. A task is
characterised by a unique task number and is assigned to a specific industry or authority
user. A task is created in order to complete certain actions that are required from the
applicant or another authority user.
Both tasks and messages are the starting point for an authority user to start
working in R4BP 3. Cases and assets are used for reference, i.e., to know more
about the terms and conditions of an authorisation, to know more about related
cases or to verify in the events history section the status of a case.
3.4.1 Search for tasks
When you select the ‘TASKS’ tab, a page is displayed with a searchable table containing all
of the tasks assigned to you.
You can search for a specific task by filling in some search criteria (Figure 4):
1. Filter task items by: “All open tasks (default)”, ‘Completed’, “ Overdue”, ‘My group(s)
claimed tasks’, ‘My group(s) unclaimed tasks’, ‘Claimed by me’.
2. Task name: e.g. ‘BRC confirmation, ‘MSCA accept’, ‘Evaluate & Decide’, ‘Reply to
communication’.
3. IVA steps: For further information please go to chapter 3.10.
4. ‘Due date’, ‘Submission date’, ‘Creation date’, ‘Completion date’ filters can be selected
here.
5. The “from” and “to” dates, linked to point 4 can be inserted here.
6. You can search here by ‘Task number’ (please insert only digits).
7. Case number: enter the unique ID of the case. The case number is created in R4BP 3 as
soon as an application is submitted.
8. Case types: the codes and a short description of each case types is given in the drop
down menu. A list of case types is provided in the table of content of this manual.
9. Product name: for applications related to biocidal products, enter the complete product
name.
10. Common name (AS): for IUCLID 5 applications related to active substances, enter the
common name.
11. You can export the selected list of tasks in .xls format (excel) by clicking the “Export
(.xls)” button.
Figure 4: Searching for a task
When searching for a product name, you can type part of the name
and all the entries containing that letter(s) combination will be
displayed.
Search in R4BP 3 is not case sensitive.
No integrated “Back” button exists. A new search needs to be
performed in R4BP 3 if you select one task and intend to go back to
your initial search results.
3.4.2 The task list
The tasks are displayed in the ‘Tasks list’ (Figure 5) under the ‘TASKS’ tab and include the
following information:
1. Task name describing the task type (e.g.Validate application). The “I” stands for initiator
(you can also find “V” and “A” standing for validator and authoriser respectively). The
task name is a hyperlink to the corresponding task item. For further information please
go to chapter 3.10.
2. Case number is a hyperlink to the corresponding ‘Case details’ page (Figure 8).
3. Product name if provided in the dossier or in the SPC (when submitting a dossier is not
mandatory) .
4. Active substance name.
5. Case type
6. Submission date of the case.
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7. Due date.
8. Tasks can have the following statuses:
Unclaimed: all open tasks created and not yet claimed by a specific user.
Claimed: a task that is claimed by a specific user in order to perform the actions
of a task.
Completed: once the claimant of a task performs the task actions and completes
the task, its status changes to ‘Completed’. The task is considered closed; you
can view the task details, but cannot perform any further actions.
R4BP 3 provides in the task list a reminder feature through which late
and soon to be late tasks are highlighted. The task will not be auto-
completed even if the deadline is missed but it will appear as late in
the users’ task list.
Figure 5: ‘Tasks list’
3.5 Messages
R4BP 3 is the communication channel between authority and industry users (Article 71(6)
BPR). In particular, an authority user will use the messages tab to check the status of the
messages received and sent via R4BP 3. Information on how to send messages is given in
section 3.12 (ad hoc communication). ECHA advises R4BP 3 users to regularly check
whether there are any new messages in their message inbox.
Note that the messages available in the ‘MESSAGES’ tab are in “read-only” format. You
cannot reply to a message from this tab. Please see section 3.12.
Any message sent by you as an authority user will be assigned a unique number, i.e. a
‘Communication number’ or a ‘Decision number’.
You can search for a specific message by filling in some search criteria like (Figure 6):
1. Sent/Received filter buttons.
2. Communication number.
3. Sender: e.g. “Industry”, “Agency” or “MSCA”.
4. Message status: ‘Read’ or ‘Unread’.
5. The received “from” and “to” dates.
Figure 6: Searching for a message
3.5.1 Message search results
The messages are displayed in the ‘Message list’ under the ‘Messages’ tab and include the
following information:
1. From or To.
2. Topic: Subject (this is hyperlinked to the communication details)
3. Product/Substance name.
4. Received or Sent Date.
3.6 Cases
A case identifies an application or notification upon successful submission of an application
or notification in R4BP 3. A series of steps need to be completed by authority users in the
application process leading up to the decision according to the BPR. The purpose of a case
is to manage and view the progress of the application and its evaluation.
3.6.1 Search for Cases
When you select the ‘TASKS’ tab, a page is displayed with a searchable table containing all
of the tasks assigned to you.
You can search for a specific case by filling in some search criteria (Figure 7):
1. Case number: unique code create for each application.
2. Case types: the codes and a short description of each case types is given in the drop
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down menu. A list of case types is provided in the table of content of this manual.
3. Case status: e.g. In Progress, closed.
4. Dossier UUID: enter the unique universal identifier of the IUCLID dossier (41 alpha-
numeric code).
5. Evaluating Authority Type: e.g. ECHA or MSCA.
6. Evaluating Country (MSCA).
7. Company UUID: enter the unique universal identifier of the relevant company (41 alpha-
numeric entries).
8. Product name: for applications related to biocidal products, enter the complete product
name.
9. Common name (AS): for IUCLID 5 applications related to active substances, enter the
common name.
10. Product types: List of the 22 product type as reported in Annex V of the BPR.
11. Submission date “From” and “To”.
12. You can export the selected list of tasks in .xls format (excel) by clicking the “Export
(.xls)” button.
Figure 7: Searching for a case
The ‘Case list’ is similar to the ‘Task list’
Figure 8: ‘Case list’
Case details page
Specific information on the cases can be found in the case details page. To display the
‘Case details’ page (Figure 9) click on one of the case number (Figure 8).
The ‘Case details’ page may contain the following information and tabs, depending on the
application type:
Product or Active substance information and Case owner details are displayed it the upper
part of the ‘Case details’ page. From the “Action” button on the top-right you may either initiate an Ad-hoc
communication or download the Case in .pdf format.
Tabs:
1. Reference details
2. SPC tab: The latest set of SPC files submitted for a specific Case
3. Dossiers: List of IUCLID dossiers submitted with the case.
4. Company details: Information about the case owner and asset owner.
5. Events history: The authority Events history displays all the events occurred from
initial submission to final decision per case.
6. Documents: Displays all exchanged documents between authority and industry
(including documents generated via the ad hoc communication), except for:
submitted IUCLID dossiers, which are listed under the ‘Dossiers’ sub-tab, and
financial related documents (i.e. invoices, credit notes), which are listed
under the ‘Financial management’ sub-tab.
By default, documents are sorted according to their creation date.
7. Financial management: Under this sub-tab, the authority user attaches and sends
invoices/credit notes to the case owner (applicant). You can also change the status
of the invoice, e.g. awaiting payment, unpaid, fee paid, credited. 8. Related cases: Information about any case initiated from the context of the
presented case (i.e. child cases) and any other cases that have been initiated from
the same context as the present case (e.g. cases in other Member States for
mutual recognition in parallel, same BP).
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Figure 9: “Case details page”
The screenshot was taken for the case type ‘NA-APP Application for national
authorisation’. Depending on the case type, the case details page may differ slightly
from the one in the screenshot.
3.7 Case event history
In the specific tab all the steps of a case are displayed in chronological order. This
information can be filtered by steps or by the date as shown in Figure 10.
The “Case inventory history page” is a useful record of all steps in the sequence of events of
a process.
The case event history contains useful information for you such as whether the Agency has
accepted or not an application, dossier UUID or the stakeholder who performs a particular
action.
Steps in red italics can be viewed only by administrator users; steps in bold can be viewed
by administrators, authority and industry users.
An important improvement introduced in R4BP 3.2 is that the events step summarising the
submissions from Industry or the decisions from the Authority (completion of task items
and requests for resubmission) provide also a link to a page that summarizes the details of
each submission/decision or a link to the communication details page.
Figure 10: Case inventory history page
3.8 Assets
An asset is a positive regulatory decision on an application related mainly to either an AS
(e.g. approval of the AS or a decision on technical equivalence) or a BP (e.g. a national
authorisation, incl. mutual recognitions, or a Union authorisation), or a notification (e.g.
notification of experiment or test).
Searching for assets is similar to searching for tasks, cases or messages.
Figure 11: Searching for an asset
The available asset records are displayed in the ‘Assets list’ (Figure 12)
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Figure 12: ‘Assets list’
When a product asset is displayed, also the information on the related active substance(s)
is given in the next column. When the asset number hyperlink is clicked, the ‘Asset details’
page is displayed (Figure 13).
Figure 13: ‘Asset details’ page
Please note that the “create a new case” button allows you to short
cut the steps needed to perform certain processes e.g. amendment or
cancellation of an asset.
The ‘Asset details’ page contains different tabs depending on the
asset type: e.g. the “family info” tab only appears for asset related to
product family authorisation.
Authority users will be able to define, which document will be
included in the final asset when finalising the last task item in the
workflow before the asset is created or changed. Additionally will also
be able to manage this document afterwards from the asset tab.
3.9 Case types
An list of BPR processes called ‘case types’ in R4BP 3 can be found in the table of content
of this manual. These processes are described in detail in chapters 4 to 45. In addition, a
chapter on settlement of disagreements is included (Chapter 26). This process is not a
separate one in R4BP 3 but is relevant for the finalisation of certain processes and this is
the reason why it is included in the present manual.
The processes not relevant for MSCAs are not described in this manual. Information on
these processes can be found however on the ECHA website dedicated to R4BP 3
submissions and in the appropriate submission manuals for industry also available from
the ECHA website.
R4BP 3.2 does not include all BPR processes. It is foreseen that the missing
processes will be incorporated in future releases. Meanwhile if some of these
processes are necessary, they will be implemented by ECHA in the form of a work
around (WA).
3.10 Claiming and completing a task
Only the initiator step is described. Following the initiator, two further roles may be
implemented in future: the V(verifier) and the A(authoriser). The default
configuration for MSCAs is currently set only to one cycle: ‘I’.
Under the ‘TASKS’ tab, search for the open tasks in combination with any relevant search
criterion. Click on the task listed as ‘MSCA accept, I - Initiator. The screenshot below
provides an example for ‘MSCA accept I’ (Figure 15). Please keep in mind that for certain
processes the first step is “Validate” (Figure 20)
Step 1: Click on the ‘TASKS’ tab
Step 2: Search for the relevant task, e.g. using the product name and/or case type, i.e.
national authorisation, mutual recognition in sequence, etc.
Figure 14: ‘TASKS’ page
Step 3: Claim a task by selecting ‘Start working’. The task is then automatically assigned
to you and its status is changed to ‘Claimed’ (Figure 15).
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Figure 15: ‘MSCA accept’ page
Figure 16: ‘MSCA accept’ page, release the task function.
Step 4: Complete the task actions and finalise your task item by clicking on ‘complete’
(Figure 18).
As soon as you have claimed the task, you become the user to finalise
it. If you need to release the task in order to be claimed by other users
you have the choice to ‘release’ (Figure 16) the task. By doing this the
status is automatically changed back to ‘Unclaimed’. Releasing a task
can be necessary if the claimant is absent while the task needs to be
completed urgently.
The complete button is disabled until the mandatory fields, marked with an asterisk ( ),
have been filled in correctly.
Figure 17: ‘MSCA accept’ page 1/2
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Figure 18: ‘MSCA accept’ page 2/2
Step 5: Then click ‘Continue’ to process the task.
Figure 19: ‘Complete task confirmation’ page
At the end of a process, the applicant receives a message indicating the outcome of the
task. If necessary, a task item to be completed by the applicant might be generated, e.g. if
you request additional information.
Please note that in R4BP 3.1, to align the processes with the legislative provisions, the
task “Evaluation” in R4BP 3.0 has been replaced by several successive tasks such as
“MSCA accept” (Figure 18), “Validate” (Figure 20), “Evaluate” (Figure 21) or “Evaluate
& Decide” (Figure 22). The differences between these tasks are explained in the
process chapters.
Consequently, where a case in R4BP 3.0 was at the “Evaluation” task-step before the
migration to 3.1 but in reality the MSCA is still doing e.g. the validation task, the
automatic migration will not know that the case should go to “Validate” task.
Consequently, the case will be mapped automatically into the “Evaluate” or “Evaluate &
Decide” task depending on the case type. Thus, the MSCA will still have to record
manually the decision taken during the preceding steps.
New cases coming to the MSCA after the migration 3.0 to 3.1 will go through all the
needed steps normally.
Figure 20: ‘Validate’ page of the “Validate” task.
Figure 21: ‘Evaluate’ page of the “Evaluate” task.
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Figure 22:‘Evaluate & Decide’ page of the “Evaluate & Decide” task.
Figure 23: Management of SPC files.
This area enables the authorities to define the SPC files that will be attached to the final
decision. You can also amend an asset (using NA-AAT) and define the SPC file(s) that
supports the authorisation after it is granted in R4BP 3 (see chapter 3.10.2).
Figure 24: Management of asset document.
This area enables the authorities to define the documents (like PAR, CAR) that will be
attached to the final decision. You can also manage them afterwards through those case
types that support changes in the asset context (e.g. NA-AAT).
3.10.1 SPC
The manual on how to compile the SPC editor can be downloaded here.
It is important to remember that there is a pre-filled SPC in the SPC section within certain
cases provided by the applicant (see table 2). Therefore, The MSCA does not need to fill in
the SPC template completely. MSCA can download the SPC provided in the application,
insert (potential) missing data and eventually upload it in R4BP 3 before finalising the task.
Please note that R4BP 3 completes automatically the SPC with certain information, provided
that they are present in the system, once the MSCA approves an authorisation.
More precisely R4BP 3 will transfer the following information: authorisation number,
reference number, authorisation date, expiry date. Furthermore the following information on
the authorisation holder will be automatically completed: UUID, name, address, postal code,
city and country.
If an applicant resubmits an application after a request for additional information (chapter
3.11), the SPC data will be refreshed with the latest information re-submitted.
The following table summarises in which processes (case types) related to authorisations a
SPC is needed in the application. A list of definitions of case types is given in the table of
content of this document.
Table 2: Case type and SPC correlation table
Case type SPC Case type SPC Case type SPC
NA-APP Yes NA-BBS Yes SA-NPF Yes
NA-MRP Yes NA-NPF Yes SA-CAT No
NA-MRS Yes SA-APP Yes SA-AAT amend
NA-RNL Yes (optional)* SN-NOT Yes PP-APP No
NA-CAT No SN-AAT amend PP-AAT No
NA-AAT amend** SN-CAT No PP-CAT No
NA-ADC Yes SA-ADC Yes UA-APP Yes
NA-TRS Yes SA-TRS Yes NE-NOT No
NA-MRG Yes SA-MIC Yes SE-NOT No
NA-MIC Yes SA-MAC Yes UP-APP Yes
NA-MAC Yes SA-BBP Yes ET-NOT No
NA-BBP Yes SA-BBS Yes
* optional means that the SPC is not mandatory but it is suggested
** amend means that the SPC can be submitted by the CA when amending a NA, SA or PP.
3.10.2 Agreeing on and replacing the SPC
Please note that for the time being a .xml files cannot be sent via ad hoc communication.
Consequently, in all those processes where an exchange of SPC among CAs is needed
before the final approval/non approval of the application (NA-MRP, NA-MRS, NA-RNL,
NA-MIC, NA-MAC, SA-MIC and SA-MAC) a work around is needed.
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Therefore RMS/cMS can exchange the draft SPC for the purposes of agreeing on the SPC via
ad hoc communication provided that they open SPC, modify it, and attach (procedure in the
link) a .zip format version of the SPC to the ad hoc communication (see chapter 3.12).
Comments on the SPC in .zip format should be given by reply to the ad hoc communication
where relevant. The same approach can be used to agree on the final SPC with the
applicant in relevant cases (if the agreed SPC is requested via the request additional info
task the action will “stop the clock” as described in section 3.11).
The final, agreed SPC in .xml format, can be uploaded by the CA before finalising the EVL
task (Figure 23) and after editing the changes with the SPC Editor. The final SPC can also be
uploaded, at a later stage, by the CA using the relevant XX-AAT case types (“amend” case
type in Table 2).
3.11 Request additional information with resubmit task
This task needs to be used when the BPR allows additional information to be requested
and a “stop the clock” process is foreseen.
Step 1: Search for the relevant task, e.g. using the product name and/or case type.
Step 2: Claim the task by selecting ‘Start working’.
Step 3: Select ‘Request additional Info’ in the field ‘Please select one of the following
allowed actions based on your decision’ (Figure 25).
Figure 25: ‘Provide your decision page’1/2
Step 4: Type a message to the applicant and set the due date for when your request
needs to be completed (Figure 26).
Step 5: In addition to the field “Message to the owner”, you may also upload a document
describing your request for additional information, set the language in which the
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request is written and put the relevant classification type (Figure 26)
Step 6: Complete the task.
Figure 26: ‘Provide your decision page’2/2
3.12 Ad hoc communication
An ad hoc communication may be used to inform other Member States and ECHA about
decisions taken by a MSCA or to create a task for an applicant for which no submission of
data by the applicant is necessary (e.g. to request for the payment of an invoice). Using
the financial tab (Figure 29) will generate only a message to the applicant; using the ad
hoc communication will also create a task to the applicant.
Step 1: Search for the relevant case, e.g. using the product name and/or case type
(Figure 7).
Step 2: In the relevant ‘Case details’ page, press the ‘Actions’ button and select ‘New
communication’ (Figure 9).
Step 3: Fill in the requested fields in the ‘Ad hoc communication’ box to create a new
communication. In the field ‘Topic’, select the best fitting option.
Figure 27: Select the Topic’ page
For authority users, only some subjects from the dropdown menu are
relevant, e.g. evaluation, ad hoc invoicing, comments, opinion, SPC,
product sameness and validation.
Step 1: Tick the box ‘Reply required’ and set the appropriate deadline in days. Only
when the box ‘Reply required’ is ticked a task to the recipient will be
created. In other cases, the message will be delivered to the Messages tab.
Step 2: By selecting the click box “reply required” and pressing ‘Send’ the
communication is forwarded to the applicant, the appropriate MSCAs or to
ECHA. A task will be created for the user to which you have sent your
communication.
Under the ‘Events history’ sub-tab in the ‘Case details’ page (Figure 10), you
can see that the message was sent out.
The documents you attached to the ad hoc communication are accessible via
the ‘Documents’ sub-tab in the ‘Case details’ page.
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Step 3: Click ‘Continue’ to proceed.
With the ad hoc communication in R4BP 3, no IUCLID 5 dossier can
be requested. Should you require a IUCLID 5 dossier from the
applicant, you need to use the ‘Request additional information’ with
the resubmit task (section 3.11).
For the time being it is not possible to send a .xml file through the ad
hoc communication in R4BP 3. To send SPC in zip format please
follow the instruction in chapter 3.10.2.
Choose the topic ‘Comment’ in the topic field, if no better selection is
available in the dropdown menu.
The ‘Request additional information’ function (section 3.11) stops the
clock and puts on hold the running time the MSCA has for a task
(legal period). Therefore, to ask for clarification to resolve small
inconsistencies in the dossier, or in all cases where a stop of the clock
is not foreseen by the BPR, the MSCA may use the ad hoc
communication, which does not have any effect on the task duration
and does not trigger the possibility for resubmission of a IUCLID 5
file.
3.13 Invoicing, financial information
The creation of national invoices is out of the scope of R4BP 3.
Therefore, each MSCA should use its own system to prepare invoices.
However, R4BP 3 needs to be used for sending the invoice to the
applicant and to record the status of the payments.
MSCA should invoice only after a relevant task has been created by
the system e.g. “MSCA accept” or “Validate”. By failing to do so there
is a risk that an invoice is sent before the previous step is actually
completed and the invoice have to be refunded if the application is
rejected in the previous step.
Step 1: Search for the relevant case, e.g. using the product name and/or case type
Step 2: Open the ‘Case details’ by clicking on the case number hyperlink.
Step 3: Under ‘Case details’, select the ‘Financial management’ sub-tab.
Figure 28: Case details – Financial management tab’ page
Step 4: Under ‘Financial management’, click the ‘Upload invoice’ button in the ‘Handle
invoices’ section (Figure 29).
Figure 29: ‘Financial information’ page
Step 5: Fill in the fields and upload the pdf file of your original invoice. Choose the
language in which the invoice has been created (Figure 30 and Figure 31).
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Figure 30: ‘Upload new invoice’ page
Figure 31: ‘Upload new invoice’ page, select language
Step 6: Click ‘Send’ in order to send the invoice to the applicant (Figure 32).
Figure 32: ‘Financial information - send’ page
Step 7: Click ‘Continue’ to proceed.
Figure 33: ‘Confirmation message’ page
Step 8: Once you have received the payment, change the fee status from ‘Awaiting
payment’ to ‘Fee paid’ in the ‘Financial management’ sub-tab of the relevant
case (Figure 34). The applicant will be informed automatically via R4BP 3.
Figure 34: ‘Financial information – handle invoices – Fee paid’ page
Step 9: If the fee has not been paid within 30 days, change the fee status to ‘Fee unpaid’
in the ‘Financial management’ tab of the relevant case (Figure 35). According to
the BPR, the application is to be rejected if the fees are not paid within 30 days.
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Figure 35: ‘Financial information – handle invoices – unpaid’ page
For all national processes (i.e. except those relevant at Union level), you can reject a case
yourself, if the payment is not done within 30 days.
For processes related to Union level, an ad hoc communication needs to be sent to ECHA
requesting the rejection of the application due to non-payment of the invoice. ECHA will
then reject the application in R4BP 3.
Processes at Union level include: active substance approval (including renewal,
amendment and review of active substance approval) and Union authorisation of biocidal
products (including a change, authorisation of the same and renewal of Union
authorisation).
Cancelling and changing invoices can be recorded by setting the status of the invoice to
‘Credited’. You can then upload the credit note and the corrected invoice. By clicking
‘Send’, both documents are sent to the applicant.
3.14 Acceptance, validation, evaluation, approval/rejection
Generally, the workflow of biocides processes follows the pattern of acceptance, validation,
evaluation and ends resulting in an approval, non-approval or a rejection of an application.
Rejection can be the outcome at any of the steps. Please note that these terms are not
related to legal acts (decisions, regulations) but only to the applications themselves.
Acceptance is the first step in the processing of an application and it is finalised once the
payment is received. If an invoice is not paid within the given deadline, the application will
be rejected at this stage. The acceptance step has to be finalised within the 30 days
deadline.
The validation is understood to be a verification step to ensure the application is
complete. The time for the MSCAs to finalise the validation step is usually 30 days from
acceptance date. More information on which issues need to be validated is described in the
chapters of the specific processes in this manual. If the application is found to be invalid, a
request for additional information can be made that must be completed by the industry
user within a defined deadline. In some processes, the validation step was used for
confirmation whether the full evaluation is needed or not.
The evaluation of the applications follows the validation step. Once the validation is
finalised, the evaluation of the application can start. The evaluation time of the eCA (or the
rMS) depends on the process. If further information is needed during this step, a request
for additional information can be made that must be completed by the industry user within
a defined deadline. This action will “stop the clock” and the eCA (or the rMS) will need to
specify the deadline industry has to comply with the request.
Approval is the positive outcome of the process after the evaluation step (for those case
types managed by the MSCA). For cases having SPC the authority user should further
review and update, if required, the SPC package (in the correct .xml format) of the final
SPC files attached for the specific case.
Non-approval is the negative outcome of the process after the evaluation step (for those
case types managed by the MSCA).
Rejection is a negative outcome, that can occur in the acceptance, the validation or the
evaluation steps. Rejection is appropriate to use in cases of non-payment of the fee or
failure to submit additional information requested by the authority (where this is justifiable
by the legislation).
To approve, non-approve or reject an application in R4BP 3, select the appropriate option
from the drop-down menu of the relevant task page and upload the decision and, where
relevant, the appropriate documents (e.g. SPC). Complete the task page to move to the
following task or to close the application.
Applications for approval of active substances and for Union
authorisation of biocidal products can only be approved or non-
approved by Commission in R4BP 3.
If the applicant fails to pay the fee within the 30-day deadline, the
MSCA should reject the application and complete the task or inform
ECHA if it relates to an application for which a MSCA cannot reject.
3.15 Business rules – quality of dossiers
Before applications are accepted by ECHA they pass through the ECHA submission
pipeline. This includes a virus check, format validation and a check of process specific
business rules. It also applies for resubmit tasks when a new dossier is required (request
for additional information).
You can find more information on the submission to ECHA in Chapter 6 ‘How ECHA handles
your submission’ of the Biocides Submission Manual 2- Using R4BP 3 for biocide
applications directed at applicants.
3.16 Classification of documents – Access level
Authorities have to classify the documents they upload:
Public: meaning that the document may be disseminated as uploaded and visible to
both industry and authority users in the asset/case/task/message context that it is
uploaded in.
Restricted: meaning that the document is visible to both industry and authority users
in the asset/case/task/message context in which it is uploaded, but it will not be
disseminated as uploaded.
Restricted – Authority: meaning that the document is only visible to authority users
in the asset/case/task/message context in which it is uploaded and will not be
disseminated as uploaded
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Important note about the access level: When uploading your dossier
and/or supporting documents in the R4BP 3 application ‘wizard’, you are
required to indicate an ‘access level’ as either ‘public’ or ‘private’. The ‘access
level’ is purely indicative and is in no way binding on ECHA. Despite your
indication, any submissions you send to ECHA are subject to, amongst
others, the applicable provisions on dissemination in the Biocidal Products
Regulation and its implementing instruments, Regulation (EC) No 1049/2001
on public Access to Documents and Regulation (EC) No 1367/2006 on the
application of the provisions of the Aarhus Convention on Access to
Information.
3.17 What to do if you need support
ECHA offers a dedicated service to the MSCAs in using the Agency’s information systems
and performing their duties in the context of the BPR.
Detailed instructions on how to contact ECHA to request this service are given in the
Biocides Guide for authority users ‘How to contact ECHA should you need support’
(distributed via e-mail to the CA).
4. AS-APP Active substance approval
4.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
4.2 Workflow
BRC > EAA > VAL > MEV > OPN > DEC
4.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
4.4 Steps to be followed by the MSCA
The eCA needs to claim the task during the approval process and can request further
information through the task item.
Step 1: Claim the ‘Validate’ task.
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the
applicant via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see
section 3.13). If the fee is not paid within 30 days reject the application (see
section 3.14)
Step 3: Complete the actions in the “Validation” page (Figure 20).
Validate the application within 30 days of receiving the task from ECHA according to BPR
Articles 7(3). This validation includes verifying whether:
the information requirements for the active substance are fulfilled;
the information requirements for the representative product(s) are fulfilled;
BPR Article 5(2) is applicable if exclusion criteria are met according to BPR Article
5(1);
Justifications have been submitted for the adaptation of information
requirements.
The validation should not include an assessment of the quality or the adequacy of the data
or justifications submitted.
a. If the information requirements are fulfilled, complete the validation task and
follow on with Step 4.
b. If the information requirements described above are not fulfilled, inform the
applicant what additional information is required for validating the application
(further information in sections 3.11). Set a reasonable time limit for the
submission of the additional information. This shall normally not exceed 90 days.
c. Validate the application within 30 days of receipt of the additional information. Reject the application if the applicant fails to submit the requested information
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within the deadline or the information requirements remain incomplete. In such
case, part of the fees paid by the applicant to the eCA may need to be
reimbursed.
Step 4: Claim the “Evaluate” task and complete the actions in the “Evaluation” page
(Figure 21).
Evaluate the application within 365 days (BPR Article 8(1)). The following tasks related to
R4BP 3 can be considered during the evaluation:
a. Annotate IUCLID 51 file where relevant.
b. via the request additional information function you can request further
information and stop the clock. Set a reasonable time limit for the submission of
the additional information. This shall normally not exceed 180 days. Reject the
application (see section 3.14) if the applicant fails to submit the requested
information within the deadline. The applicant will be automatically notified.
c. Inform ECHA via ad hoc communication (see section 3.12) as soon as possible
on issues identified that may need to be discussed at a working group meeting
already before submitting the competent authority report (CAR) and the dossier
enters the peer review phase.
d. Inform ECHA via ad hoc communication if the active substance is a potential
candidate for substitution.
e. Perform confidentiality claims check by evaluating the justifications submitted by
the applicant.
f. ECHA suggests that not later than 60 days before the end of the 365-day
evaluation period, the eCA would send the CAR and conclusions for a 30-day
commenting period to the applicant. Reply to the applicant’s comments and
adapt the CAR accordingly if necessary.
Step 5: Peer review
a. Send the CAR to ECHA for initiation of the peer review stage.
4.5 Supporting documents
Template agreement to act as CA;
5. AS-EVA Active substance evaluation under Directive
98/8/EC
5.1 Workflow
BRC > EAA > VAL > MEV > OPN > DEC
5.2 Application requirements
This process derives from the assessment of the existing active substances under the BPD
and is supported by Article 90 of the BPR. The only application requirements is for the
active substance to be in the review programme under the BPD.
5.3 Steps to be followed by the MSCA
The eCA needs to claim the task during the approval process and can request further
information through the task item.
Please note that some of the dossiers may be migrated directly in the “Evaluation” task
since they are in a more advanced state of the assessment. For these cases you need to
complete directly the “Evaluation” task.
Step 1: Claim the ‘Validate’ task and complete the actions in the “Validation” page (Figure 20).
This validation includes verifying whether:
the information requirements for the active substance are fulfilled;
the information requirements for the representative product(s) are fulfilled;
BPR Article 5(2) is applicable if exclusion criteria are met according to BPR Article
5(1)3;
Justifications have been submitted for the adaptation of information
requirements.
The validation should not include an assessment of the quality or the adequacy
of the data or justifications submitted.
a. If the information requirements are fulfilled, follow on with Step 4.
b. When relevant (i.e. new active substance applications), if the information
requirements described above are not fulfilled, inform the applicant what
additional information is required for validating the application. Use ‘Request
additional information’ (from the task details) which will stop the clock. Set a
reasonable time limit for the submission of the additional information. This shall
normally not exceed 90 days.
c. Validate the application within 30 days of receipt of the additional information in
R4BP 3. Reject the application if the applicant fails to submit the requested
information within the deadline or the information requirements remain
incomplete. Inform the applicant and ECHA of the rejection via ad hoc
communication in R4BP 3 (see sections 3.11) using the template mentioned in
the supporting documents section below. In such cases, part of the fees paid by
the applicant to the eCA may need to be reimbursed.
Step 4: Complete the task actions “Evaluate” (Figure 21).
Evaluate the application (the Review Regulation sets a 365 day period). The
following tasks related to R4BP 3 can be considered during the evaluation:
a. When relevant, annotate IUCLID 51 file and/or the study summaries where
relevant.
b. Consult with ECHA via ad hoc communication if additional information is
3 As further clarified in Commission note on the principles for taking decisions on the approval of active substances
under the BPR CA-March14-Doc.4.1 - Final - Principles for the approval of AS
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required. Request additional information as described in Step 3 b above. For
‘stop the clock’ requests, please inform ECHA via ad hoc communication.
c. Inform ECHA on issues identified that may need to be discussed at a working
group meeting via ad hoc communication (see sections 3.11) already before
submitting the CAR and the dossier enters the peer review phase.
d. Inform ECHA if the active substance is a potential candidate for substitution via
ad hoc communication.
g. Perform confidentiality claims check by evaluating the justifications submitted by
the applicant.
h. ECHA suggests that not later than 60 days before the end of the 365-day
evaluation period, the eCA would send the CAR and conclusions for a 30-day
commenting period to the applicant. Reply to the applicant’s comments and
adapt the CAR accordingly if necessary.
Step 5: Peer review
Send the CAR to ECHA for initiation of the peer review stage.
6. AS-NAS New active substance evaluation under Directive 98/8/EC
6.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
6.2 Workflow
BRC > EAA > VAL > MEV > OPN > DEC
6.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
This process derives from the assessment of the new active substances under the BPD and
is supported by Article 90 of the BPR. The only application requirements is that an
approval request was submitted for a new active substance under the BPD.
6.4 Steps to be followed by the MSCA
Please follow the steps in chapter 4.4.
7. AS-RNL Renewal of the approval of an active substance
7.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
7.2 Workflow
BRC > EAA > VAL > MEV > OPN > DEC
7.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
7.4 Steps to be followed by the MSCA
See section 4.4
7.5 Supporting documents
Template agreement to act as eCA;
8. AN-APP (1-5) Amendment of Annex I
8.1 Introduction
The process relates to the amendment of category 1 to 5 of Annex I to the BPR.
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
8.2 Workflow
BRC > EAA > MAA > MEV > OPN > DEC
8.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
8.4 Steps to be followed by the MSCA
Step 1: Claim the “MSCA accept” task.
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the
applicant via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see
section 3.13).
Step 3: Complete the actions in the “MSCA accept” page (Figure 18).
Check whether the fee has been paid within 30 days (3a) or not (3b).
a. If the fee has been paid, accept the application and proceed with Step 4. The
applicant will be notified accordingly by the system.
b. If the fee has not been paid, reject the application. The applicant will be
automatically notified.
Step 4: Claim the “Evaluate” task and complete the actions in the “Evaluation” page
(Figure 21).
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Evaluate the application within 180 days. The following tasks related to R4BP 3 can be
considered during the evaluation:
a. via the request additional information function you can request further
information and stop the clock. Set a reasonable time limit for the submission of
the additional information. This shall normally not exceed 180 days. Reject the
application (see section 3.14) if the applicant fails to submit the requested
information within the deadline. The applicant will be automatically notified.
b. Inform ECHA via ad hoc communication (see section 3.12) as soon as possible
on issues identified that may need to be discussed at a working group meeting
already before submitting the competent authority report (CAR) and the dossier
enters the peer review phase.
i. Perform confidentiality claims check by evaluating the justifications submitted by
the applicant.
j. ECHA suggests that not later than 60 days before the end of the 180-day
evaluation period, the eCA would send the CAR and conclusions for a 30-day
commenting period to the applicant. Reply to the applicant’s comments and
adapt the CAR accordingly if necessary.
k. Complete the Evaluate task selecting “Submit evaluation”.
Step 5: Peer review
Send the CAR to ECHA for initiation of the peer review stage.
8.5 Supporting documents
Template agreement to act as CA;
9. AN-APP (6) Amendment of Annex I
9.1 Introduction
The process relates to the amendment of category 6 of Annex I to the BPR.
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
9.2 Workflow
BRC > EAA > VAL > MEV > OPN > DEC
9.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
9.4 Steps to be followed by the MSCA
The procedure to be followed is the same of AS-APP or AS-EVA. Please See section 4.4.
9.5 Supporting documents
Template agreement to act as CA;
10. NA-APP National authorisation
10.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
10.2 Workflow
BRC > MAA > VAL > EVL
10.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
10.4 Steps to be followed by the MSCA
The steps described here are not relevant for applications for mutual
recognition in parallel. If you are the rMS for an application, which
shall be mutually recognised in parallel, please refer to chapter 14.
Step 1: Claim the “MSCA accept” task.
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the
applicant via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see
section 3.13).
Step 3: Complete the actions in the “MSCA accept” page (Figure 18).
Check whether the fee has been paid within 30 days (3a) or not (3b).
c. If the fee has been paid, accept the application and proceed with Step 4. The
applicant will be notified accordingly by the system.
d. If the fee has not been paid, reject the application. The applicant will be
automatically notified.
Step 4: Claim the ‘Validate’ task and complete the actions in the ‘Validation’ page (Figure
20).
Validate the application within 30 days of the acceptance date. According to the
BPR (Article 29(2)), the validation includes verifying:
whether the relevant information described in Article 20 of the BPR has been
submitted;
that the statement of the applicant that no application for national authorisation of
the same biocidal product for the same use has been submitted to any other
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MSCA. A template is provided by ECHA on the website and should be included in
the application by the applicant as a supporting document.
The validation shall not include an assessment of the quality or adequacy of the
data or justifications submitted.
a. If the information requirements described above are fulfilled, complete and
proceed with Step 5.
b. If the information requirements described above are not fulfilled, inform the
applicant of the additional information that is required for validation. Through
‘request additional information’ (see section 3.11) a resubmission task item for
the applicant is created to submit an updated IUCLID 5 dossier or other file type
supported by the case type wizard.
Set a reasonable time frame for the submission of the additional information
which should normally not exceed 90 days. Validate the application within 30
days of receipt of the additional information.
Reject the application if the applicant fails to submit the requested information by
the deadline (see section 3.14).
c. If the applicant has already submitted an application for national authorisation for
the same biocidal product and the same use in another Member State, reject the
application and inform the applicant of the possibility of seeking mutual
recognition. As R4BP 3 does not allow checking this by searching the data base at
the moment, this has been implemented by the obligatory inclusion of the above
mentioned supporting document by the applicant.
Step 5: Claim the “Evaluate & Decide” task
Within 365 days, evaluate whether an authorisation can be granted in
accordance with Article 19 of the BPR. This evaluation step takes place outside
R4BP 3. The following tasks related to R4BP 3 can be performed during the
evaluation:
a. Annotate IUCLID 51 file where relevant.
b. Request additional information from the applicant if necessary to carry out the
evaluation. Through ‘request additional information’ (see section 3.11) a
resubmission task item for the applicant is created to submit a new IUCLID 5
dossier or other file type and it will stop the clock. Set a reasonable period for the
submission of the additional information, which should normally not exceed 180
days in total. Reject the application (see section 3.14) if the applicant fails to
submit the requested information within the deadline. The applicant will be
automatically notified.
c. Draft a product assessment report (PAR) summarising the conclusions of the
assessment and the reasons for authorising or refusing to grant the
authorisation. Amend if necessary the draft SPC generated by the applicant. Send
an electronic copy of the PAR and the SPC to the applicant through ad hoc
communication (see section 3.12) and provide the opportunity to submit
comments within 30 days (request reply).
d. Finalise the assessment taking into account the comments provided by the
applicant.
e. Perform a confidentiality claims check by evaluating the justifications submitted
by the applicant.
f. Complete the actions in the “Evaluate & Decide” page by selecting “Approve
application” (Figure 22).
Close the task by approving or not approving the application for the product
authorisation (see section 3.14) and at the same time upload the final PAR and SPC to
R4BP 3.
The final SPC must not include confidential information, as it will be made
publicly available.
Applications for authorisation of the same biocidal product will appear as
related asset of the reference product (see Article 7 of the Implementing
Regulation (EU) No 414/2013). Whenever an authorisation is granted or not,
the related cases should be checked as the connections are not automated.
11. NA-APP (WA) Provisional national authorisation Article 55(2)
11.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
11.2 Workflow
BRC > MAA > VAL > EVL
11.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
11.4 Steps to be followed by the MSCA
Step 1: Claim the “MSCA accept” task (see section 3.10).
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the
applicant via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see
section 3.13).
Step 3: Complete the actions in the “MSCA accept” page (Figure 18).
Check in your national invoicing system whether the fee has been paid within 30
days (3a) or not (3b).
a. If the fee has been paid, complete and proceed with Step 4. The applicant will be
notified accordingly.
b. If the fee has not been paid, reject the application. The applicant will be
automatically notified.
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Step 4: Claim the ‘Validate’ task and complete the actions in the ‘Validation’ page (Figure
20).
Validate the application within 30 days of the acceptance date. According to the
BPR (Article 29(2)), the validation includes verifying:
Whether the evaluating competent authority has given a recommendation for
approval in the CAR (please check the CAR uploaded in the CIRCA BC page
under the new active folders)whether the relevant information described in
Article 20 of the BPR has been submitted;
The validation shall not include an assessment of the quality or adequacy of the
data or justifications submitted.
a. If the information requirements described above are fulfilled, complete and
proceed with Step 5 by selecting “Validate”.
b. If the information requirements described above are not fulfilled, inform the
applicant of the additional information that is required for validation. Through
‘request additional information’ (see section 3.11) a resubmission task item for
the applicant is created to submit an updated IUCLID 5 dossier.
Set a reasonable time frame for the submission of the additional information
which should normally not exceed 90 days. Validate the application within 30
days of receipt of the additional information.
Reject the application if the applicant fails to submit the requested information by
the deadline (see section 3.14).
c. If the applicant has already submitted an application for national authorisation for
the same biocidal product and the same use in another Member State, reject the
application and inform the applicant of the possibility of seeking mutual
recognition. As R4BP 3 does not allow checking this by searching the data base at
the moment, this has been implemented by the obligatory inclusion of the above
mentioned supporting document by the applicant.
Step 5: Claim the “Evaluate & Decide” task
Evaluate whether an authorisation can be granted in accordance with Article 19 of
the BPR. The duration of the evaluation period is still under discussion by the COM
services. The following tasks related to R4BP 3 can be considered during the
evaluation:
a. Annotate IUCLID 51 file where relevant.
b. Request additional information from the applicant if necessary to carry out the
evaluation. Inform the applicant what additional information is required. Through
‘request additional information’ (see section 3.11) a resubmission task item for
the applicant is created to submit a new IUCLID 5 dossier or other file type and it
will stop the clock. Set a reasonable period for the submission of the additional
information which should normally not exceed 180 days in total.
Reject the application (see section 3.14) if the applicant fails to submit the
requested information within the deadline. The applicant will be automatically
notified.
c. Draft a product assessment report (PAR) summarising the conclusions of the
assessment and the reasons for authorising or refusing to grant the
authorisation. Amend if necessary the draft SPC generated by the applicant.
d. Perform a confidentiality claims check by evaluating the justifications submitted
by the applicant.
e. Send an electronic copy of the PAR and the SPC to the applicant through ad hoc
communication (see section 3.12) and provide the opportunity to submit
comments within 30 days (request reply). Finalise the assessment taking into
account the comments provided by the applicant.
f. Complete the actions in the “Evaluate & Decide” page by selecting “Approve
application” (Figure 22).
Close the task by approving or not approving the application for the product
authorisation (see section 3.14) and the same time upload the final PAR and SPC
to R4BP 3.
The final SPC must not include confidential information, as it will be publicly
available.
Applications for authorisation of the same biocidal product will appear as
related asset of the reference product (see Article 7 of the Implementing
Regulation (EU) No 414/2013). Whenever an authorisation is granted or not,
the related cases should be checked as the connections are not automated.
* The duration of the evaluation period is still under discussion within the
COM services.
12. NA-RNL Renewal of National authorisation
12.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
12.2 Workflow
BRC > MAA > VAL > EVL
12.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
MSCAs need to determine whether they are rMS or cMS.
12.4 Steps to be followed by the MSCA
Step 1: Claim the “MSCA accept” task.
Step 2: There should not be any supporting document in the document tab and you
should proceed directly with Step 3. In case there is a supporting document this
means that the case refers to a mutual recognition renewal and you should refer
to chapter 13.
Step 3: Issue an invoice according to Article 80(2) of the BPR and send it to the
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applicant via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see
section 3.13).
Step 4: Complete the actions in the “MSCA accept” page (Figure 18).
Check whether the fee has been paid within 30 days (3a) or not (3b).
a. If the fee has been paid accept the application and proceed with Step 4. The
applicant will be notified accordingly.
b. If the fee has not been paid, reject the application (see section 3.14) and inform
the applicant accordingly through ad hoc communication (see section 3.12).
Similarly, inform the rMS if relevant (if a supporting document is present in the
application).
Step 5: Claim the ‘Validate’ task and complete the actions in the ‘Validation’ page (Figure
20).
Decide within 90 days of accepting an application whether a full evaluation of the
application for renewal is necessary taking account of all product-types for which
renewal is needed. A tick box is provided in R4BP 3 to support this option.
Step 6: Claim the “Evaluate & Decide” task and complete the actions in the “Evaluate &
Decide” page (Figure 22).
In case a full evaluation of the application is necessary, evaluate it within 365 days whether
a renewal of an authorisation can be granted in accordance with Article 30 of the BPR. This
evaluation step takes place outside R4BP 3. The following tasks related to R4BP 3 can be
performed during the evaluation:
a. Annotate IUCLID 51 file where relevant.
b. Request additional information from the applicant if necessary to carry out the
evaluation. Through ‘request additional information’ (see section 3.11) a
resubmission task item for the applicant is created to submit a new IUCLID 5
dossier or other file type and it will stop the clock.
c. Set a reasonable time frame for the submission of the additional information
which should normally not exceed 180 days in total. Reject the application (see
section 3.14) if the applicant fails to submit the requested information within the
deadline. The applicant will be automatically notified.
d. Draft a product assessment report (PAR) summarising the conclusions of the
assessment and the reasons for authorising or refusing to grant the
authorisation. Amend if necessary the draft SPC generated by the applicant.
e. Send an electronic copy of the PAR and SPC to the applicant through ad hoc
communication (see section 3.12) and provide the opportunity to submit
comments within 30 days (request reply). Finalise the assessment taking into
account the comments provided by the applicant.
In case a full evaluation of the application is not necessary evaluate it within 180 days of
accepting the application.
Step 1: Complete the actions in the “Evaluate & Decide” page by selecting “Approve
application” (Figure 22).
Close the task by approving or not approving the application for the renewal of national
authorisation (see section 3.14) and at the same time, if relevant, upload the final PAR
and SPC to R4BP 3.
The final SPC must not include confidential information, as it will be
publicly available.
13. NA-RNL Renewal of National authorisation subject to mutual recognition
13.1 Introduction
This is in practice the same case type used for single product authorisation renewal except
that the applicant will request in a single submission the renewal of all (or some) the
assets related by mutual recognition. Communication with concerned MSCA is therefore
needed. Please consult this chapter of the BPR Practical Guide for a description of the
regulatory requirements and the related process.
13.2 Workflow
BRC > MAA > VAL > EVL
13.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
MSCAs need first to determine whether they are rMS or cMS by checking the
supporting document.
The grouped submission of renewal application is the principle introduced by
the Commission Regulation No 492/2014 in order to avoid unnecessary
duplication of the evaluation procedures by the Competent Authorities (CA).
This practical approach is also recommended for the sake of consistency
during the evaluation process. However, in case of mutually recognised
authorisations, which have different Authorisation Holders the grouped
submission is not mandatory and up to the Authorisation Holder choice to
nominate another company making the grouped application for renewals.
In case companies decide to submit the applications for renewal separately,
these separate applications may not be linked together and could therefore
be evaluated separately by the (possibly different) receiving MSs as it is
described in Article 31 of the BPR (taking into account exceptions for biocidal
products containing chlorophacinone, bromadiolone or coumatetralyl).
Note also technical limitations explained below due to which two or more
submissions may need to be combined for evaluation by a single rMS under
the Commission Regulation No 492/2014.
13.4 Steps to be followed by the reference MSCA
Step 1: Claim the “MSCA accept” task.
Step 2: A supporting document (Renewal of authorisation subject to mutual recognition)
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should be present under the Documents tab. If there is no supporting document
this means that the case refers to a renewal not involving any mutual
recognition and you should refer to chapter 12.
Step 3: If there is such supporting document, check in the supporting document whether
you are rMS or cMS. Please note that this information or the related cases
cannot be read from the case details. Furthermore, since there may be missing
links in the R4BP 3 database among the related NA assets, applicants may need
to apply under the regulation 492/2014 in more than one submissions. The kind
of submission (main or additional) can be deduced from the supporting
document(s).
The rMS is given by the asset from which the applicant starts the main
submission. The additional submissions cover related assets that could not be
included in the main submission for which the corresponding competent
authorities become cMSs.
In order to ensure the information on the rMS/cMS and the additional
submissions is available to all rMS/cMS and to potentially enable their combined
assessment with the main submission, ECHA will send the supporting documents
of the main and additional submissions to the rMS and the cMS through ad hoc
communication.
For cMS next steps refer to chapter 13.5.
Step 4: Issue an invoice according to Article 80(2) of the BPR and send it to the
applicant via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see
section 3.13).
Step 5: Complete the actions in the “MSCA accept” page (Figure 18).
Check whether the fee has been paid within 30 days (3a) or not (3b).
a. If the fee has been paid accept the application and proceed with Step 4. The
applicant will be notified accordingly.
b. If the fee has not been paid, reject the application (see section 3.14). The
applicant will be notified accordingly. Inform the concerned CA through ad hoc
communication (see section 3.12) using the template from the supporting
documents sections below.
Step 6: Claim the ‘Validate’ task and complete the actions in the ‘Validation’ page (Figure
20).
Within 30 days of the acceptance in the reference Member State, that Member
State shall validate the application if it contains all the relevant information
referred to in Article 2.
a. If the information requirements described above are fulfilled, select “Validate”
complete and proceed with Step 6.
b. If the information requirements described above are not fulfilled, request
additional information (chapter 3.11) and set a reasonable period for the
submission of the additional information, which should normally not exceed 90
days in total.
c. Select “reject” if the additional information are not sufficient to validate the
application.
d. Decide within 90 days of accepting an application whether a full evaluation of the
application for renewal is necessary taking account of all product-types for which
renewal is requested. A tick box is provided in R4BP 3 in the validation page to
support this option. The reference CA must send an ad hoc communication to the
concerned CAs to inform them about the evaluation type of their choice.
Step 7: Claim the “Evaluate & Decide” task and complete the actions in the “Evaluate &
Decide” page (Figure 22).
In case a full evaluation of the application is necessary, evaluate it within 365 days*
whether a renewal of an authorisation can be granted in accordance with Article 30 of the
BPR. The following tasks related to R4BP 3 can be considered during the full evaluation:
a. Annotate IUCLID 51 file where relevant.
b. Request additional information from the applicant if necessary to carry out the
evaluation. Through ‘request additional information’ (see section 3.11) a
resubmission task item for the applicant is created to submit a new IUCLID 5
dossier or other file type and it will stop the clock. Set a reasonable time frame
for the submission of the additional information which should normally not
exceed 180 days in total. Reject the application (see section 3.14) if the applicant
fails to submit the requested information within the deadline. The applicant will
be automatically notified.
c. Draft a product assessment report (PAR) summarising the conclusions of the
assessment and the reasons for renewal or refusing to renew the authorisation.
Amend if necessary the draft SPC generated by the applicant.
d. Send an the PAR and SPC to the applicant through ad hoc communication (see
section 3.12) and provide the opportunity to submit comments within 30 days
(request reply). Finalise the assessment taking into account the comments
provided by the applicant.
e. Within 365 days of validating the application, the rMS shall send draft PAR and
SPC through ad hoc communication to the cMS and to the applicant.
*In case a full evaluation of the application is not necessary evaluate it within 180 days
of validating the application. Please note that in this case step 6(b) does not apply.
Agreement by cMS and decision taking:
a. All the cMSs express their position on the draft SPC within 90 days of the receipt
of the draft PAR and SPC from rMS by sending their decision on the agreement
through ad hoc communication to the rMS, the other cMSs and the applicant. If
a cMS expresses a disagreement with the draft SPC and the PAR prepared by the
rMS, the rMS shall refer the detailed explanation of the points of disagreement
and the reasons for position received from the cMS to the Coordination Group
without delay (see Chapter 26).
b. Following the 90 days, the rMS will take a decision on the renewal of the national
authorisation within 30 days and close the task by approving or not approving
the application for the renewal of national authorisation (see section 3.14). The
rMS uploads the agreed SPC and the final PAR in R4BP 3 together with any
agreed terms and conditions on the making available on the market or use of the
biocidal product.
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The final SPC must not include confidential information, as it will be
publicly available.
13.5 Steps to be followed by the concerned MSCAs
Step 1: Claim the “MSCA accept” task.
Step 2: Check whether there is a supporting document (Renewal of authorisation subject
to mutual recognition) under the Documents tab (sent to you by ECHA) which
indicates who the rMS and the respective cMSs are. The supporting documents
you receive should be giving you the status of cMS. This information or the
related cases cannot be read from the case details in the R4BP 3.
Furthermore, since there may be incorrect links in the R4BP 3 database among
the NA assets, applicants may need to apply under the regulation 492/2014 in
more than one submissions. The kind of submission (main or additional) can be
deduced from the supporting document(s).
The rMS is given by the asset from which the applicant starts the main
submission. The additional submissions cover related assets that could not be
included in the main submission for which the corresponding competent
authorities become cMSs.
In order to ensure the information on the rMS/cMS and the additional
submissions is available to all rMS/cMS and to potentially enable their combined
assessment with the main submission, ECHA will send the supporting documents
of the additional submissions to the rMS and the cMS through ad hoc
communication.
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the
applicant via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see
section 3.13).
Step 3: Complete the actions in the “MSCA accept” page (Figure 18).
Check whether the fee has been paid within 30 days (3a) or not (3b).
a. If the fee has been paid, complete and proceed with Step 4. The applicant will be
notified accordingly.
b. If the fee has not been paid, reject the application (see section 3.14). The
applicant will be automatically notified. Send the information also to the rMS and
where relevant other cMSs through ad hoc communication (see section 3.12)
using the template mentioned in the supporting documents section below.
Step 4: Claim the ‘Validate’ task.
Provided that the rMS has validated the application, within 30 days of the
acceptance the concerned Member State(s) will verify that the application it has
received falls within the scope of the supplementary rules for renewal as per
Article 1(2) and (3) of Commission Delegated Regulation (EU) No 492/2014. If
not, the application for renewal must be processed under the regular renewal
procedures set out in Article 31 of the BPR. In this case the MSs shall inform the
other concerned MS via ad hoc communication. Such MS should process the
application following the steps described in section 12.5.
A tick box is provided in this task to indicate which kind of evaluation will be
performed by the rMS and the cMS must select the same evaluation type chosen
by the rMS.
Step 5: Claim the “Evaluate & Decide” task.
In case a full evaluation of the application is necessary, within 365 days* of validating an
application, the rMS shall evaluate the application and draft a PAR in accordance with Article
30(3) and send it together with the SPC through ad hoc communication to the cMSs and to
the applicant.
a. All the cMSs express their position on the draft SPC within 90 day of the receipt
of the draft PAR and SPC from rMS by sending their decision on the agreement
through ad hoc communication to the rMS, the other cMSs and the applicant
using the template from the supporting documents sections below.
b. In case a given cMS agrees with the draft SPC and the PAR (a positive
assessment report), the cMS completes the actions in the “Evaluate & Decide”
page (Figure 22) and renews the authorisation within 30 days of reaching the
agreement in conformity with the agreed SPC and closes the task by approving
the application for the renewal of national authorisation (see section 3.14).
Within 7 days after agreement, SPC should be translated by the applicant in all
applicable languages. The finalised respective language version of the SPC must
be uploaded by the cMS when approving the renewal. (The rMS shall upload the
agreed SPC and the final PAR in R4BP 3 together with any agreed terms and
conditions on the making available on the market or use of the biocidal product
when approving the application for the renewal of national authorisation.)
Make sure to assign the same expiry date as for the reference product. To find
the expiry date of the reference product go to the related cases tab of your case’s
details page and copy the reference number of the reference product (see point 8
of Figure 9). Search for the reference authorisation using this number.
c. If you disagree with the draft SPC, send a detailed explanation of the points of
disagreement and the reasons for your position to the rMS, the other cMSs, the
applicant and, where applicable, the authorisation holder through ad hoc
communication. This shall be referred by the rMS to the Coordination Group
without delay (see Chapter 26).
d. If you refuse to grant the authorisation of the BP or want to adjust the terms and
conditions of the authorisation to be granted according to Article 37 of the BPR,
and on the grounds of Article 7 of Regulation (EU) No 492/2014, communicate a
detailed statement of the grounds for seeking a derogation to the applicant via ad
hoc communication and seek an agreement. If the agreement between the two is
not reached, the cMS informs COM via ad hoc communication who takes the final
decision.
*In case a full evaluation of the application is not necessary the rMS will evaluate it within
180 days of validating the application. Please note that in this case step 6(b) of chapter
13.4 does not apply.
The final SPC must not include confidential information, as it will be
publicly available.
13.6 Supporting documents
Template agreement/disagreement on SPC
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Template for rejection of an application.
14. NA-MRP Mutual recognition in parallel
14.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
14.2 Workflow
BRC > EAA > MAA > VAL > EVL
14.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
14.4 Steps to be followed by the MSCA
14.4.1 Steps to be followed by the rMS
Step 1: Claim the “MSCA accept” task (see section 3.10).
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the
applicant via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3
(see section 3.13).
Complete the actions in the “MSCA accept” page (Figure 18). Check whether the fee has
been paid within 30 days (3a) or not (3b).
a. If the fee has been paid, accept the application and proceed with Step 3. The
applicant will be notified accordingly.
b. If the fee has not been paid within 30 days, reject the application and inform via
ad hoc communication the cMS using the template mentioned in the supporting
documents section below.
Step 3: Claim the ‘Validate’ task and complete the actions in the ‘Validation’ page (Figure
23). Validate the application within 30 days of the acceptance date in accordance
with Article 29(2) and (3) of the BPR. The validation includes verifying:
whether the relevant information described in Article 20 of the BPR has been
submitted,
the statement of the applicant that no application for national authorisation of the
same biocidal product for the same use has been submitted to any other MSCA. A
template is provided by ECHA on the website and should be included in the
application by the applicant as a supporting document.
The validation should not include an assessment of the quality or adequacy of the data or
justifications submitted.
a. If the information requirements described above are fulfilled, select “Validate”
complete and proceed with Step 5.
b. If the information requirements described above are not fulfilled, inform the
applicant of the additional information that is required for the validation. Through
‘request additional information’ (see section 3.11) a resubmission task item for
the applicant is created to submit a new IUCLID 5 dossier or other file type.
Set a reasonable period for the submission of the additional information which
should normally not exceed 90 days. Validate the application within 30 days of
receipt of the additional information.
Reject the application if the applicant fails to submit the requested information by
the deadline (see section 3.14) and inform the cMS accordingly through ad hoc
communication (see section 3.12) using the template mentioned in the
supporting documents section below.
c. If the applicant has already submitted an application for national authorisation for
the biocidal product with the same use in another Member State, reject the
application and inform the applicant of the possibility of seeking mutual
recognition.
Step 4 Claim the “Evaluate & Decide” task.
Within 365 days of validating the application, evaluate the application whether an
authorisation can be granted in accordance with Article 19. The following tasks related to
R4BP 3 can be considered during the evaluation:
a. Annotate IUCLID 51 file where relevant.
b. Request additional information from the applicant if necessary to carry out the
evaluation. Through ‘request additional information’ (see section 3.11) a
resubmission task item for the applicant is created to submit a new IUCLID 5
dossier or other file type and it will stop the clock. Set a reasonable time frame
for the submission of the additional information which should normally not exceed
180 days in total. Reject the application (see section 3.14) if the applicant fails to
submit the requested information within the deadline. The applicant will be
automatically notified.
c. Draft a product assessment report (PAR) summarising the conclusions of the
assessment and the reasons for authorising or refusing to grant the
authorisation. Amend if necessary the draft SPC generated by the applicant.
d. Perform a confidentiality claims check by evaluating the justifications submitted
by the applicant.
e. Send an electronic copy of the PAR and the SPC to the applicant through ad hoc
communication (see section 3.12) and provide the opportunity to submit
comments within 30 days (request reply). Finalise the assessment taking into
account the comments provided by the applicant.
f. Within 365 days of validating an application, the rMS shall send draft PAR and
SPC (see chapter 3.10.2 and 3.12) through ad hoc communication to the cMS
and to the applicant.
Agreement by cMS and decision taking:
a. All the cMSs express their position on the draft SPC within 90 days of the receipt
of the draft PAR and SPC from rMS by sending the agreement through ad hoc
communication to the rMS, the other cMSs and the applicant. If a cMS expresses
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a disagreement with the draft SPC prepared by the rMS, the rMS shall refer the
detailed explanation of the points of disagreement and the reasons for position
received from the cMS to the Coordination Group without delay (see Chapter
26).
b. Following the 90 days, the rMS will take a decision on the renewal of the national
authorisation, the rMS grants the national authorisation within 30 days and close
the task by approving or not approving the application for the renewal of
national authorisation (see section 3.14). The rMS uploads the agreed SPC and
the final PAR in R4BP 3 together with any agreed terms and conditions on the
making available on the market or use of the biocidal product (see Figure 24 and
Chapter 3.10.2).
14.4.2 Steps to be followed by the cMS
Step 1: Claim the “MSCA accept” task (see section 3.10).
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the
applicant via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3
(see section 3.13).
Complete the actions in the “MSCA accept” page (Figure 18). Check whether the fee has
been paid within 30 days (3a) or not (3b).
a. If the fee has been paid, accept the application and proceed with Step 4. The
applicant will be notified accordingly.
b. If the fee has not been paid within 30 days, reject the application and inform via
ad hoc communication the cMS.
Step 3: Claim the ‘Validate’ task (see section 3.10). Complete the actions in the
‘Validation’ page (Figure 20). Select “validate” or “reject” in line with the
decision of the rMS.
Step 4: Claim the “Evaluate & Decide” task.
Within 365 days of validating an application, the rMS shall evaluate the application and draft
a PAR in accordance with Article 30(3) and send it together with the SPC through ad hoc
communication to the cMS and to the applicant.
a. All the cMSs express their position on the draft SPC within 90 days of the receipt
of the draft PAR and SPC from rMS by sending decision on the agreement
through ad hoc communication to the rMS, the other cMSs and the applicant (see
chapter 3.10.2).
b. In case a given cMS agrees with the draft SPC , the cMS, completes the actions in
the “Evaluate & Decide” page (Figure 22) and grant the authorisation within 30
days of reaching the agreement in conformity with the agreed SPC and close the
task by approving the application for granting a national authorisation (see
section 3.14). Within 7 days after agreement, SPC should be translated by
applicant in all applicable languages (as requested by the cMS). The finalised
respective language version of the SPC must be uploaded by the cMS when
approving the authorisation. (The rMS shall upload the agreed SPC and the final
PAR in R4BP 3 together with any agreed terms and conditions on the making
available on the market or use of the biocidal product when approving the
application for granting a national authorisation (see chapter 3.10.2)).
Make sure to assign the same expiry date as for the reference product. To find
the expiry date of the reference product go to the related cases tab of your case’s
details page and copy the reference number of the reference product (see point 8
of Figure 9). Search for the reference authorisation using this number.
c. If you disagree with the draft SPC prepared by the rMS, send a detailed
explanation of the points of disagreement and the reasons for your position to
the rMS, the other cMSs, and the applicant through ad hoc communication. This
shall be referred by the rMS to the Coordination Group without delay (see
Chapter 26).
d. If you refuse to grant the authorisation of the BP or want to adjust the terms and
conditions of the authorisation to be granted according to Article 37 of the BPR,
communicate a detailed statement of the grounds for seeking a derogation to the
applicant through ad hoc communication and seek to reach an agreement on the
proposed derogations.
14.5 Supporting documents
Template agreement/disagreement on SPC.
Template rejection of an application.
15. NA-MRS Mutual recognition in sequence
15.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
15.2 Workflow
BRC > EAA > MAA > VAL > EVL
15.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
15.4 Steps to be followed by the MSCA
Step 1: Claim the “MSCA accept” task (see section 3.10).
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the
applicant via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see
section 3.13).
Step 3: Complete the actions in the “MSCA accept” page (Figure 18).
Check whether the fee has been paid within 30 days (3a) or not (3b).
a. If the fee has been paid accept and proceed with Step 4. The applicant will be
automatically notified.
b. If the fee has not been paid, reject the application. The applicant will be
automatically notified (see section 3.14). If there are applications for mutual
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recognition in sequence in other Member States, inform the other cMSs
accordingly through ad hoc communication (see section 3.12).
Step 4: Claim the ‘Validate’ task and complete the actions in the ‘Validation’ page (Figure
20).
Validate the application within 30 days of the acceptance date in accordance with
Article 33(2) of the BPR and proceed with Step 5.
Step 5: Claim the “Evaluate & Decide” task.
Within 90 days of validating the application,
a. If you agree on the SPC, record your agreement by sending the agreement
through ad hoc communication to the applicant and, if applicable, to the other
cMSs (see chapter 3.10.2 on how to agree on the SPC).
In case the cMS agree on the SPC, the cMS complete the actions in the “Evaluate
& Decide” page (Figure 22) and grants the authorisations within 30 days of
reaching agreement in conformity with the agreed SPC and closes the task by
approving the application for the national authorisations (see section 3.14).
Before closing the task, upload the agreed SPC in R4BP 3 (see chapter 3.10.2).
Within 7 days after agreement, SPC should be translated by applicant in all
applicable languages (as requested by the cMS). The finalised respective
language versions of the SPC must be uploaded by the cMS when approving the
authorisation.
Make sure to assign the same expiry date as for the reference product. To find
the expiry date of the reference product go to the related cases tab of your
case’s details page and copy the reference number of the reference product (see
point 8 of Figure 9). Search for the reference authorisation using this number.
b. If you consider that the BP assessed by the rMS does not meet the conditions
laid down in Article 19 of the BPR, send a detailed explanation of the points of
disagreement and the reasons for your position to the rMS, the other cMSs, and
the applicant through ad hoc communication. This shall be referred by the rMS to
the Coordination Group without delay (see Chapter 26).
c. If you refuse to grant the authorisation of the BP or want to adjust the terms
and conditions of the authorisation to be granted according to Article 37 of the
BPR, communicate to the applicant a detailed statement of the grounds for
seeking a derogation through ad hoc communication and seek to reach an
agreement on the proposed derogations.
15.5 Supporting documents
Template agreement/disagreement on SPC.
Template rejection of an application.
Particular case: Mutual recognition in sequence related to
applications submitted under the BPD regime.
15.6 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
The case is related to an application for a national authorisation to the rMS and an application for mutual recognition to cMSs submitted before 1 September 2013.
The reference number (in the R4BP 3 this is the asset number) of the initiating application
for national authorisation can be found in the ‘General’ sub-tab in the ‘Case details’ page of the application for mutual recognition.
The application must contain the translation of the original authorisation in the rMS, SPC in
an editable format in a language accepted by the cMS and relevant documents for each
cMS as referred to in Annex II to "Notes for guidance to applicants for product
authorisation and mutual recognition" (CA-Sept12-Doc.6.2.a –Final.Rev2 -28/01/2013).
15.7 Workflow
BRC > EAA > MAA > VAL > EVL
15.8 Application requirements
The applicant has submitted an application for a national authorisation to the
rMS and an incomplete application for mutual recognition or an intention to
submit an application for mutual recognition after the first authorisation will have
been granted to cMSs before 1 September 2013;
The rMS grants the first authorisation after the 1 September 2013 without prior
transmission of its assessment report and SPC to the cMSs.
15.9 Steps to be followed by the MSCA
Step 1: Claim the “MSCA accept” task (see section 3.10) and complete the actions in the
“MSCA accept” page (Figure 18).
Fees under this step have already being paid at the time of the submission before
the BPR entered into operation.
Step 2: Claim the ‘Validate’ task and complete the actions in the ‘Validation’ page (Figure
20).
Validate the application within 30 days of the acceptance date in accordance with
Article 33(2) of the BPR and proceed with Step 5.
Step 3: Claim the “Evaluate & Decide” task.
Within 90 days of validating the application,
a. If you agree on the SPC, record your agreement in R4BP and by sending the
agreement through ad hoc communication to the applicant and, if applicable, to
the other cMSs (see chapter 3.10.2 on how to agree on the SPC).
In case a given cMS agrees on the SPC (and a positive assessment report), the
cMS completes the actions in the “Evaluate & Decide” page (Figure 22) and
grants the authorisation within 30 days of reaching agreement in conformity with
the agreed SPC and close the task by approving the application for the national
authorisation (see section 3.14). Before closing the task, upload the agreed SPC
in R4BP 3 (see chapter 3.10.2). Within 7 days after agreement, SPC should be
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translated by applicant in all applicable languages (as requested by the cMS). The
finalised respective language versions of the SPC must be uploaded by the cMS
when approving the authorisation.
Make sure to assign the same expiry date as for the reference product. To find
the expiry date of the reference product go to the related cases tab of your case’s
details page and copy the reference number of the reference product (see point 8
of Figure 9). Search for the reference authorisation using this number.
b. If you consider that the BP assessed by the rMS does not meet the conditions laid
down in Article 19 of the BPR, send a detailed explanation of the points of
disagreement and the reasons for your position to the rMS, the other cMSs, the
applicant and, where applicable, the authorisation holder through ad hoc
communication. This shall be referred to the Coordination Group without delay
(see Chapter 26).
c. If you refuse to grant the authorisation of the BP or want to adjust the terms and
conditions of the authorisation to be granted according to Article 37 of the BPR,
communicate to the applicant a detailed statement of the grounds for seeking a
derogation through ad hoc communication and seek to reach an agreement on
the proposed derogations.
15.10 Supporting documents
Template agreement/disagreement on SPC.
Template rejection of an application.
16. NA-BBP, NA-BBS National authorisation of the same
biocidal product
16.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
Authorisations can be sought in a Member State where a national authorisation according
to the BPD or the BPR has already been granted (authorised, NA-BBS) or an application for
such an authorisation has been submitted (pending, NA-BBP).
16.1 Workflow
BRC > MAA > VAL > EVL
16.2 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
16.3 Steps to be followed by the MSCA
16.3.1 NA-BBS National authorisation of same biocidal product (authorised)
Step 1: Claim the ‘MSCA accept’ task.
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the
applicant via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see
section 3.13).
Step 3: Complete the actions in the “MSCA accept” page (Figure 18).
Check whether the fee has been paid within 30 days (3a) or not (3b).
a. If the fee has been paid accept and proceed with Step 4. The applicant will be
notified accordingly.
b. If the fee has not been paid, reject the application (see section 3.14). The
applicant will be automatically notified (see section 3.14).
Step 4: Claim the ‘Validate’ task and complete the actions in the ‘Validation’ page (Figure
20).
Validate the application within 30 days of the acceptance date. Check whether all
information described in Article 2 of Implementing Regulation (EU) No 414/2013 has been
submitted and the proposed differences concern only administrative changes (3a) or not
(3b).
a. “Validate” and proceed with Step 5. Or
b. “Reject application” (see section 3.14)
Step 5: Claim the “Evaluate & Decide” task (Figure 22) and complete the actions.
Within 60 days of validating the application, evaluate whether the biocidal
product is identical to the reference product, except for information on
administrative changes according to Implementing Regulation (EU) No
354/2013.
a. Close the task by approving or not approving the application for the product
authorisation (see section 3.14). Upload the final SPC with your decision.
Make sure to assign the same expiry date as for the reference product. To find the
expiry date of the reference product go to the related cases tab of your case’s details
page and copy the reference number of the reference product (see point 8 of Figure
9). Search for the reference authorisation using this number.
For the reference product a link is given to the same biocidal products under the
related assets/cases as appropriate.
The final SPC must not include confidential information, as it will be
publicly available.
Figure 36: Tracking the reference case or asset of a same biocidal product
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16.3.2 National authorisation of same biocidal product (pending, NA-BBP)
For national authorisation of the same biocidal product (pending), the applicant submits an
application for product authorisation (the reference product) to the Member States, creating
the reference case, and simultaneously asks for the authorisation of one or more same
biocidal product(s). When the reference product is authorised the authorisation of the same
biocidal product(s) can be granted. Since the process is not automated the MSCA needs to
follow the finalisation of the reference case and continue with this process once the
authorisation of the reference product is granted. Until finalisation of the reference product
authorisation, the authorisation of the same biocidal product cannot be granted.
Follow steps 1-3 of the same biocidal product (authorised) as appropriate. When a decision
is made with regard to the authorisation of the reference product proceed with step 4, 5 and
6. Please ensure that the decision on authorisation is sent within 60 days from the date of
the decision concerning the related reference product.
17. NA-ADC National authorisation - Administrative change on request
17.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
The possibility to transfer an authorisation to a new holder is listed as an
administrative change in the Changes Regulation (Annex, title 1, section 1,
item 3). However, this type of application must be made through the
procedure ‘transferring a national authorisation’ outlined in chapter 18.
The possibility to transform a frame formulation into a product family is also
listed as an administrative change in the Changes Regulation (Annex, title 1,
section 1, item 6). However, this type of application must be made through
the procedure ‘Merge of a product authorisation(s) in a family’ outlined
in chapter 19.
17.2 Workflow
BRC > MAA > EVL
17.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
17.4 Steps to be followed by the MSCA
Step 1: Claim the “MSCA accept” task (see section 3.10).
Step 2: Check whether there is a supporting document (on Change) under the
Documents tab which indicates that you are the rMS and who the respective
cMSs are. This information or the related cases cannot be read from the case
details. If the the applicant made a group submission for change in mutually
recognised assets, ECHA will send an ad hoc communication (attach the
supporting document) to all cMS listed in the supporting document notifying
them of the composition of rMS and cMS for this submission.
Step 3: Issue an invoice according to Article 80(2) of the BPR and send it to the
applicant via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see
section 3.13).
Complete the actions in the “MSCA accept” page (Figure 18). Check whether the fee has
been paid within 30 days (a) or not (b).
a. If the fee has been paid, accept the application and proceed with Step 3. The
applicant will be notified accordingly.
b. If the relevant fee has not been paid, reject the application (see section 3.14)
and inform the other cMSs of the grounds for the rejection through ad hoc
communication in R4BP 3 (see section 3.12), using the template from the
supporting documents section below.
Step 3: Claim the “Evaluate & Decide” task and complete the actions in the “Evaluate &
Decide” page (Figure 22).
Within 30 days following receipt of the notification (i. e. following the acceptance step)
a. If you agree, where relevant, amend the authorisation of the biocidal product in
conformity with the agreed change. Approve the application (see section 3.14)
and upload the amended SPC to R4BP 3. This needs to be done by each Member
State where the change applies.
b. if you disagree “do not approve” the application. This needs to be done by each
Member State where the change applies.
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17.5 Supporting documents
Template rejection of an application.
18. NA-TRS Transfer of a national authorisation
18.1 Introduction
Note that this process is an implementation of a notification of administrative change
concerning the transfer of an authorisation to a new holder related to NA assets referred
by the Changes Regulation, Annex, Title 1, Section 1, example 3. However, this type of
application must be made through this specific process type.
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
18.2 Workflow
BRC > MAA > EVL
18.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
18.4 Steps to be followed by the MSCA
Step 1: Claim the “MSCA accept” task.
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the
applicant via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see
section 3.13).
Step 3: Complete the actions in the “MSCA accept” page (Figure 18).
Check whether the fee has been paid within 30 days (3a) or not (3b).
e. If the fee has been paid accept the application and proceed with Step 4. The
applicant will be notified accordingly.
f. If the fee has not been paid, reject the application (see section 3.14). The
applicant will be notified accordingly.
Step 4: Claim the “Evaluate & Decide” task and complete the actions in the “Evaluate &
Decide” page (Figure 22).
Within 30 days following receipt of the notification (i. e. following the acceptance
step),
a. if you disagree with the transfer of the asset to a new Legal Entity established in
the EEA, select do not approve application in R4BP 3 (see section 3.14).
b. If you agree, where relevant, amend the authorisation of the biocidal product in
conformity with the information. Approve the application in R4BP 3 (see section
3.14) and upload the amended SPC to R4BP 3.
19. NA-MRG Merge of product authorisations in one product family
19.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
Note that this process is an implementation of a notification of administrative change
concerning the conversion of frame formulation established under the Biocidal Products
Directive 98/8/EC into product family listed as an administrative change in the Changes
Regulation (Annex, title 1, section 1, item 6). However, the creation of the biocidal product
family mast be made through the NA-MRG process type.
This process may also be used in situations where an applicant applied for a frame
formulation under the Biocidal Products Directive 98/8/EC but the authorisation for product
family was granted after 1 September 2013 and the system does not recognise the NA
asset as a product family. In such cases, which are not subject to fees pertaining to the
administrative changes, applicants are advised to contact the relevant MSCA.
19.2 Workflow
BRC > MAA > EVL
19.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
19.4 Steps to be followed by the MSCA
Step 1: Claim the “MSCA accept” task.
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the
applicant via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3
(see section 3.13).
Step 3: Complete the actions in the “MSCA accept” page (Figure 18).
Check whether the fee has been paid within 30 days (a) or not (b).
a. If the fee has been paid accept the application and proceed with Step 4. The
applicant will be notified accordingly.
b. If the fee has not been paid, reject the application (see section 3.14). The
applicant will be notified accordingly.
Step 2: Claim the “Evaluate & Decide” task and complete the actions in the “Evaluate &
Decide” page (Figure 22).
Within 30 days following receipt of the notification (i. e. following the acceptance step)
a. Select approve the application if you agree that the assets included for
merging fall within the specifications of the frame formulation established
under the BPD. Each of the assets becomes a family member asset. Upload
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the amended SPCs to R4BP 3. Following the approval, frame formulation is
transformed into a product family, the new product family asset will be visible
in R4BP 3. If the NA-MRG application was for a single asset, the product
family will only contain one member asset. The final SPCs for the family and
the member assets are stored in the correct family asset.
b. Select do not approve the application if you consider that the assets included
for merging do not fall within the specifications of the frame formulation
established under the BPD.
20. NA-MIC National authorisation - Minor change on request
20.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
20.2 Workflow
BRC > MAA > VAL > EVL
20.3 Application requirements
Please consult this manual of the Biocides Submission Manuals series for a description of
the application requirements related to this process.
20.4 Steps to be followed by the MSCA
20.4.1 Steps to be followed by the rMS
Step 1: Claim the “MSCA accept” task (see section 3.10).
Step 2: Check the supporting document contained in the application for the full list of the
affected authorisations and respective rMS and cMSs.
Step 3: Issue an invoice according to Article 80(2) of the BPR and send it to the
applicant via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see
section 3.13).
Step 4: Complete the actions in the “MSCA accept” page (Figure 18).
Check whether the fee has been paid within 30 days (3a) or not (3b).
a. If the fee has been paid, complete the task and move to step 5. The applicant will
be notified accordingly.
b. If the fee has not been paid within 30 days, reject the application (see section
3.14) The applicant will be automatically notified. Inform the cMSs accordingly
through ad hoc communication (see section 3.12) using the template mentioned
in the supporting documents section below.
Step 5: Claim the ‘Validate’ task and complete the actions in the ‘Validation’ page (Figure
20).
Validate the application within 30 days of the acceptance date.
The validation shall not include an assessment of the quality or adequacy of the data or
justifications submitted.
a. If the application complies with Article 5 of the changes regulation, select validate
and complete and proceed with step 6. The applicant will be automatically
notified.
b. If the application is deemed incomplete, request additional information from the
applicant using the ‘Request additional info’ functionality (see section 3.11). Set a
reasonable time limit not normally exceeding 45 days for resubmission.
i. Validate the application within 30 days of receipt of the additional
information. If the additional information submitted is sufficient, complete
the task and go to step 6. The applicant will be automatically notified.
ii. Reject the application if the applicant failed to submit the requested
information within the deadline. The applicant will be automatically
notified. Inform the cMSs via ad hoc communication (see section 3.12)
using the template mentioned in the supporting documents section below.
Step 6: Claim the “Evaluate & Decide” task and complete the actions in the “Evaluate &
Decide” page (Figure 22).
Within 90 days following validation of the application, evaluate the application. The following
tasks related to R4BP 3 can be considered during the evaluation:
a. Annotate IUCLID 51 file where relevant.
b. If additional information is needed to perform the evaluation, request additional
information from the applicant using the ‘Request additional info’ functionality
(see section 3.10) and set a reasonable time limit normally not exceeding 45
days for resubmission. The request will stop the clock for this time limit. Reject
the application (see section 3.14) if the applicant fails to submit the requested
information within the deadline. The applicant will be automatically notified.
Inform the cMSs via ad hoc communication (see section 3.11) using the letter
template from the supporting documents section below.
c. Within 90 days of validating the application, draft the assessment report and
send it, where relevant, together, with the revised SPC to the cMSs and to the
applicant via ad hoc communication (see section 3.12).
Agreement by cMS and decision taking:
a. If, within 45 days following receipt of the updated assessment report and, where
relevant, the revised SPC, the cMSs have not expressed their disagreement,
those Member States shall be deemed to have agreed with the conclusions of the
assessment report and, where relevant, the revised SPC. If cMS expresses a
disagreement with the draft SPC, the rMS shall refer the detailed explanation of
the points of disagreement and the reasons for position received from the cMS to
the Coordination Group without delay (see Chapter 26).
b. Following the 45 days, amend the authorisation of the biocidal product in
conformity with the agreed change within 30 days. Inform the applicant of the agreement by approving the application in R4BP 3 (see section 3.14). The rMS uploads the agreed SPC and updated assessment report in R4BP
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3 together with any agreed terms and conditions on the making available on the market or use of the biocidal product.
20.4.2 Steps to be followed by the cMS
Step 1. Claim the “MSCA accept” task (see section 3.10).
Step 2. Check the supporting document contained in the application for the full list of the
affected authorisations and respective rMS and cMSs.
Step 3. Issue an invoice according to Article 80(2) of the BPR and send it to the
applicant via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see
section 3.13).
Step 4. Complete the actions in the “MSCA accept” page (Figure 18).
Check whether the fee has been paid within 30 days (a) or not (b).
a. If the fee has been paid, accept the application and move to step 5. The applicant
will be notified accordingly.
b. If the fee has not been paid within 30 days, reject the application (see section
3.14). The applicant will be notified automatically. Inform the reference and
where relevant other cMSs accordingly through ad hoc communication (see
section 3.12) using the template mentioned in the supporting documents section
below.
Step 6. Claim the ‘Validate’ task and complete the actions in the ‘Validation’ page (Figure
20).
Select “validate” or “reject” in line with the validation step outcome of the rMS.
Step 7. Claim the “Evaluate & Decide” task and complete the actions in the “Evaluate &
Decide” page (Figure 22).
Within 90 days of validating an application, the rMS shall evaluate the application and draft
an assessment report and send it, where relevant, together with the SPC through ad hoc
communication to the cMSs and to the applicant.
a. Within 45 days following receipt of the updated assessment report and, where
relevant, the revised SPC, agree/disagree on the evaluation of the change(s).
Agree/disagree on the SPC by sending your position through ad hoc
communication to the rMS, the other cMSs and the applicant using the template
from the supporting documents sections below. If you disagree with the draft
SPC, include a detailed explanation of the points of disagreement. This shall be
referred by the rMS to the Coordination Group without delay (see Chapter 26). If,
within 45 days following the receipt of the updated assessment, you have not
expressed your disagreement, you are deemed to have agreed with the
conclusions of the assessment report and, where relevant, the revised SPC.
b. In case a given cMS agrees with the draft SPC, the cMS completes the actions in
the “Evaluate & Decide” page (Figure 22) and amend the authorisation within 30
days of reaching the agreement in conformity with the agreed SPC and closes the
task by approving the application for the renewal of national authorisation (see
section 3.14).
c. If you refuse to grant the authorisation of the BP or want to adjust the terms and
conditions of the authorisation to be granted according to Article 37 of the BPR,
and on the grounds of Article 7 of Regulation (EU) No 492/2014, communicate a
detailed statement of the grounds for seeking a derogation to the applicant via ad
hoc communication and seek an agreement. If the agreement between the two is
not reached, the cMS informs COM via ad hoc communication who takes the final
decision.
The final SPC must not include confidential information, as it will be publicly
available.
20.5 Supporting documents
Template agreement to act as CA;
Template for agreement/disagreement on SPC.
Template rejection of an application.
21. NA-MAC National authorisation - Major change on request
21.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
21.2 Workflow
BRC > MAA > VAL > EVL
21.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
21.4 Steps to be followed by the MSCA
21.4.1 Steps to be followed by the rMS
Step 1. Claim the “MSCA accept” task (see section 3.10).
Step 2. Check the supporting document contained in the application for the full list of
the affected authorisations and respective rMS and cMSs.
Step 3. Issue an invoice according to Article 80(2) of the BPR and send it to the
applicant via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3
(see section 3.13).
Step 4. Complete the actions in the “MSCA accept” page (Figure 18).
Check whether the fee has been paid within 30 days (a) or not (b).
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a. If the fee has been paid, accept the application and move to step 5. The applicant
will be notified accordingly.
b. If the fee has not been paid within 30 days, reject the application (see section
3.14). The applicant will be automatically notified. Inform the cMSs accordingly
through ad hoc communication (see section 3.12) using the letter template from
the supporting documents section below.
Step 5. Claim the ‘Validate’ task and complete the actions in the ‘Validation’ page (Figure
20).
Validate the application within 30 days.
The validation shall not include an assessment of the quality or adequacy of the data or
justifications submitted.
a. If the application complies with Article 5 of the changes regulation, select validate
and complete and proceed with step 6. The applicant will be automatically
notified.
b. If the application is deemed incomplete, request additional information from the
applicant using the ‘Request additional info’ functionality (see section 3.11). Set a
reasonable period normally not exceeding 90 days for resubmission.
i. Validate the application within 30 days of receipt of the additional
information. If the additional information submitted is sufficient, select
validate, complete the task and go to step 6. The applicant will be
automatically notified.
ii. Reject the application if the applicant failed to submit the requested
information within the deadline. The applicant will be automatically
notified. Inform the other cMSs via ad hoc communication (see section
3.12) using the template mentioned in the supporting documents section
below.
c. Claim the “Evaluate & Decide” task and complete the actions in the “Evaluate &
Decide” page (figure 22).
Within 180 days following validation of the application, evaluate the application. The
following tasks related to R4BP 3 can be considered during the evaluation:
a. Annotate IUCLID 51 file where relevant.
b. If additional information is needed to perform the evaluation, request additional
information from the applicant using the ‘Request additional info’ functionality
(see section 3.10) and set a reasonable time limit normally not exceeding 90
days for resubmission. The request will stop the clock for this time limit. Reject
the application (see section 3.14) if the applicant fails to submit the requested
information within the deadline. The applicant will be automatically notified.
Inform the cMSs via ad hoc communication (see section 3.11) using the letter
template from the supporting documents section below.
c. Within 180 days of validating the application, draft the assessment report and
send it, where relevant, together with the revised SPC to the cMSs and to the
applicant via ad hoc communication (see section 3.12)
Agreement by cMS and decision taking:
a. If within 90 days following receipt of the updated assessment report and, where
relevant, the revised SPC, the cMSs have not expressed their disagreement,
those Member States shall be deemed to have agreed with the conclusions of the
assessment report and, where relevant, the revised SPC. If cMS expresses a
disagreement with the draft SPC, the rMS shall refer the detailed explanation of
the points of disagreement and the reasons for position received from the cMS to
the Coordination Group without delay (see Chapter 26).
b. Following the 90 days, amend the authorisation of the biocidal product in
conformity with the agreed change within 30 days. Inform the applicant of the
agreement by approving the application in R4BP 3 (see section 3.14). The rMS
uploads the agreed SPC and updated assessment report in R4BP 3 together with
any agreed terms and conditions on the making available on the market or use of
the biocidal product.
21.4.2 Steps to be followed by the cMS
Step 1. Claim the “MSCA accept” task (see section 3.10).
Step 2. Check the supporting document contained in the application for the full list of
the affected authorisations and respective rMS and cMSs.
Step 3. Issue an invoice according to Article 80(2) of the BPR and send it to the
applicant via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3
(see section 3.13).
Step 4. Complete the actions in the “MSCA accept” page (Figure 18).
Check whether the fee has been paid within 30 days (a) or not (b).
a. If the fee has been paid, accept the application and move to step 5. The applicant
will be notified accordingly.
b. If the fee has not been paid within 30 days, reject the application (see section
3.14). The applicant will be notified automatically. Inform the reference and
where relevant other cMSs accordingly through ad hoc communication (see
section 3.12) using the template from the supporting documents section below.
Step 5. Claim the “Evaluate & Decide” task and complete the actions in the “Evaluate &
Decide” page (Figure 22).
Within 180 days following validation of the application, the rMS shall evaluate the
application and draft the assessment report and send it, where relevant, together with the
SPC through ad hoc communication to the cMSs and to the applicant.
a. Within 90 days following receipt of the updated assessment report and, where
relevant, the revised SPC, agree/disagree on the evaluation of the change(s).
Agree/disagree on the SPC by sending your position through ad hoc
communication to the rMS, the other cMSs and the applicant using the template
from the supporting documents sections below. If you disagree with the draft
SPC, include a detailed explanation of the points of disagreement. This shall be
referred by the rMS to the Coordination Group without delay (see Chapter 26). If,
within 90 days following the receipt of the updated assessment, you have not
expressed your disagreement, you are deemed to have agreed with the
conclusions of the assessment report and, where relevant, the revised SPC.
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b. In case a given cMS agrees with the draft SPC, the cMS completes the actions in
the “Evaluate & Decide” page (Figure 22) and amend the authorisation within 30
days of reaching the agreement in conformity with the agreed SPC and closes
the task by approving the application for the renewal of national authorisation
(see section 3.14).
c. If you refuse to grant the authorisation of the BP or want to adjust the terms and
conditions of the authorisation to be granted according to Article 37 of the BPR,
and on the grounds of Article 7 of Regulation (EU) No 492/2014, communicate a
detailed statement of the grounds for seeking a derogation to the applicant via ad
hoc communication and seek an agreement. If the agreement between the two is
not reached, the cMS informs COM via ad hoc communication who takes the final
decision.
21.5 Supporting documents
Template agreement to act as CA;
Template agreement/disagreement on SPC.
Template rejection of an application.
22. NA-AAT Amendment of National authorisation
22.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
Article 48 of the BPR describes the possibility for the MSCA (or COM for Union
authorisation-described in a different process – future UA-AAT) to cancel or amend an
existing national authorisation. This decision is triggered by one of the situations described
in section 22.3.
Where the competent authority intends to amend an authorisation, it shall inform the
authorisation holder and give it the opportunity to submit comments or additional
information within a specified time limit. The evaluating competent authority shall take
due account of those comments when finalising its decision.
Where the competent authority cancels or amends an authorisation it shall immediately
notify the authorisation holder, the competent authorities of the concerned Member States
and the Commission.
Competent authorities that have issued authorisations under the mutual recognition
procedure for biocidal products for which the authorisation has been cancelled or amended
shall, within 120 days of the notification, cancel or amend the authorisations and shall
notify the Commission accordingly.
In the case of disagreement between competent authorities of certain Member States
concerning national authorisations subject to mutual recognition the procedures laid down
in Articles 35 and 36 of the BPR shall apply.
22.2 Workflow
MSCA initiated > EVL
22.3 Application requirements
An existing national authorisation needs to be amended based on one of the following
situations:
the conditions referred to in Article 19 are not (longer) fully satisfied; or
the authorisation was granted on the basis of false or misleading information; or
the authorisation holder has failed to comply with its obligations under the
authorisation or under the BPR.
22.4 Steps to be followed by the MSCA
Step 1: Choose the asset to be amended, click on “Create new case” (as shown in Figure
13) and select the NA-AAT case type from the drop-down menu. This will create
a task (with a case number) that you can find in the task tab.
Step 2: Claim the task “Evaluate & Decide“.
a. Inform the AH giving the opportunity to comment in 30 days using ad hoc
communication (see section 3.12).
b. Select the option that reflects your decision on the cancellation of the
authorisation (Approve or Do not approve) under Task details in R4BP 3 (see
section 3.14). Complete the “Evaluate & Decide” task (Figure 22).
Step 3: Notify the authorisation holder (the applicant, if different than the AH), the
Commission and other MSCA (cMS) of the decision taken using ad hoc
communication (see section 3.12).
Step 4: In case of mutually recognised authorisations, each cMS shall amend the
authorisation within 120 days of the notification described in step 3 using the
same R4BP 3 process (NA-AAT).
Step 5: In case of disagreement between CA(s) on the amendment of mutually
recognised authorisations, follow the procedure described in section 26.2.
23. NA-CAT Cancellation of national authorisation
23.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
Article 48 of the BPR describes the possibility for the MSCA (or COM for Union
authorisation-described in a different process – future UA-AAT) to cancel or amend an
existing national authorisation. This decision is triggered by one of the situations described
in section 21.3.
23.2 Workflow
MSCA initiated > EVL
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23.3 Application requirements
An existing national authorisation needs to be cancelled based on one of the following
considerations:
the conditions referred to in Article 19 are not (longer) satisfied; or
the authorisation was granted on the basis of false or misleading information; or
the authorisation holder has failed to comply with its obligations under the
authorisation or under the BPR.
23.4 Steps to be followed by the MSCA
Step 1: Choose the asset to be cancelled, click on “Create new case” (as shown in Figure
13) and and select the NA-CAT case type from the drop-down menu. This will
create a task (with a case number) that you can find in the task tab.
Step 2: Claim the task “Evaluate & Decide“.
a. Inform the authorisation holder giving the opportunity to comment in 30 days
using ad hoc communication (see section 3.12)
d. Select the option that reflects your decision on the cancellation of the
authorisation (Approve or Do not approve) under Task details in R4BP 3 (see
section 3.14). Complete the “Evaluate & Decide” task (Figure 22).
Step 3. Notify the authorisation holder (the applicant, if different than the authorisation
holder), the Commission and other MSCA (cMS) of the decision taken using ad
hoc communication (see section 3.12).
Step 4. In case of mutually recognised authorisations, each cMS shall cancel the
authorisation within 120 days of the notification described in the previous step
using the same R4BP 3 process (NA-CAT).
Step 5. In case of disagreement between CA(s) on the amendment of mutually
recognised authorisations, follow the procedure described in section 26.2.
24. ET-NOT Notification for experiment or test
24.1 Introduction
Please consult the Research and Development chapter of the BPR Practical Guide for a
description of the regulatory requirements and the related process.
24.1 Workflow
BRC > EVL
24.2 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
24.3 Steps to be followed by the MSCA
Step 1. Claim the “Evaluate & Decide” task and complete the actions in the “Evaluate &
Decide” page (Figure 20).
a. If you consider that the application is incomplete, inform the applicant of the
additional information that is required. Through ‘request additional information’
(see section 3.11) a resubmission task item for the applicant is created. Set a
reasonable period for the submission of the additional information.
b. If you are satisfied that the application meets the information requirements laid
down in Article 56(2) and authorise/restrict (by selecting approve) or ban (by
selecting do not approve) the tests or experiments in line with the criteria in
Article 56(3) within 45 days of the “Evaluation started” date.
c. If the CA issues no opinion within 45 days the applicant can start the test or
experiment.
25. NA-NPF Notification of product in product family for national authorisation
25.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
25.2 Workflow
BRC > EVL
25.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
25.4 Steps to be followed by the MSCA
Step 1: Claim the “Evaluate & Decide” task.
Step 2: Complete the actions in the “Evaluate & Decide” page (Figure 22)
a. Check whether the notified product belongs to the related biocidal product family
according to the national authorisation.
b. Request additional information through the ‘request additional information’ item
(see section 3.11); a resubmission task item for the applicant is created. Set a
reasonable period for the submission of the additional information
c. If the submitted information is complete and correct, approve the notification
(see section 3.14); a new asset will be created with the authorisation number
having the suffix subsequent to the last authorised family member. All the family
members with the appropriate authorisation numbers (including the suffix) are
shown under the ‘family information’ of the related biocidal product family’s
asset. Ensure you include the correct authorisation number having the
appropriate suffix in the decision.
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d. Please note that an updated SPC needs to be uploaded before finalising the
task.as specified in Figure 23.
c. Select Do not approve the notification if the conditions for adding the product into the product family are not met.
26. Settlement of disagreements (n/a)
26.1 Pre-conditions
The applicant has submitted
o an application for mutual recognition (either in parallel or in sequence) or
o a notification for placing on the market (simplified authorisation) according to
Article 27(2) or
o an application/notification for minor/major change in relation to national
authorisation (subject to mutual recognition)/simplified authorisations
o an application for renewal of authorisations subject to mutual recognition
through R4BP 3.
According to Article 35(2) of the BPR, only concerned MSs are allowed to start
the process.
26.2 Steps to be followed by the MSCA
As mentioned in section 3.8 this process is not a separate one in R4BP 3 but is relevant for
the finalisation of the above mentioned processes. Therefore, this process is included in
the present manual. The working procedures of the Coordination Group describe how this
process is designed in detail.
The concerned Member State (cMS) shall send the detailed explanation of the points of
disagreement and the reasons for its position at the same time to the reference Member
State (rMS), the other cMSs, the Coordination Group (CG) secretariat, the applicant, and
where applicable, to the authorisation holder.
Before concluding that a formal procedure should be launched, Member States should
have an informal exchange between themselves, keeping ECHA informed.
For sending the disagreement, use the ad hoc communication in R4BP 3 (see section
3.12). You might select ‘Comments’ in the ‘Topic’ as well as in the ‘Doc. Type’ fields. For
the ‘Subject’ field please fill in ‘Referral to CG’. If you decide to also record the informal
exchange in R4BP 3, please use ‘Information to CG on Mutual Recognition issues’ in the
‘Subject’ field.
When sending the ad hoc communication to the rMS, please select the box ‘Reply
required’. In this way, a task item will be created for the rMS and by answering to that,
the communication /agreement can be recorded in R4BP 3.
If an agreement is reached in CG, the rMSs and/or cMSs need to implement the
agreement.
If no agreement is reached within the 60-day period, the rMS submits the points of
disagreement to the Commission.
27. NE-NOT Notification of an unexpected or adverse effect
national authorisation
27.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
27.2 Workflow
BRC > EVL
27.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
27.4 Steps to be followed by the MSCA
Step 1: Claim the “Evaluate & Decide” task and complete the actions in the “Evaluate &
Decide” page (Figure 22).
a. If the application does not contain sufficient information as laid down in Article
47, to assess whether authorisation needs to be amended or cancelled, request
additional information from the applicant using the ‘Request additional info’
functionality (further information in sections 3.11). Set a reasonable time limit for
the submission of the additional information.
b. Notify competent authorities of other Member States using the ad hoc
communication in R4BP 3 (see section 3.12).
c. Check whether the notified unexpected or adverse effect affects the conditions
under which the national authorisation was granted. Take a decision on whether
the authorisation needs to be amended or cancelled. Close the task selecting one
of the relevant options described in section 3.14.
Step 2. Cancel or amend the respective authorisation using NA-AAT or NA-CAT
processes. In case of amendment upload the final PAR and SPC to R4BP 3.
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28. PP-APP Parallel Trade
28.1 Introduction
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
28.2 Workflow
BRC > MAA > EVL
28.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
28.4 Steps to be followed by the MSCA
Step 1: Claim the “MSCA accept” task.
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the
applicant via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see
section 3.13).
Step 3: Complete the actions in the “MSCA accept“(Figure 18).
Check in your national invoicing system whether the fee has been paid within 30
days (3a) or not (3b).
a. Complete and proceed with Step 4.
b. Reject the application via R4BP 3.
Step 4: Claim the “Evaluate & Decide” task and complete the actions in the “Evaluate &
Decide” page (Figure 22).
Evaluate whether the biocidal product fulfils the requirements according to
Article 53(3), i.e. is identical to the reference product. Additional information
may be requested via ad hoc communication (see section 3.12) from the MSCA
of the MSO (or the applicant). The MSCA of the MSO has 30 days to provide the
requested information.
Approve or reject the parallel trade permit application via R4BP 3 within 60 days
from the date the fee has been received.
29. PP-AAT Amendment of parallel trade permit
29.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
If a parallel trade permit needs to be amended, the interested MSCA needs to initiate a
task under the case type PP-AAT.
29.2 Workflow
MSCA initiated > EVL
29.3 Application requirements
Conditions to amend a parallel trade permit need to be met.
29.4 Steps to be followed by the MSCA
Step 1: Choose the asset to be amended and select the PP-AAT action. This will create a
task (with a case number) that you can find in the task tab. Claim the task
“Evaluate & Decide“.
Step 2: Inform the permit holder giving the opportunity to comment in 30 days using ad
hoc communication (see section 3.12)
Step 3: Decide on the amendment of the permit under Task details in R4BP 3 (see
section 3.14).
Step 4: Complete the “Evaluate & Decide” task (Figure 22) by selecting “Approve” or “Do
not approve”.
30. PP-CAT Cancellation of parallel trade permit
30.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
If a parallel trade permit needs to be cancelled, the interested MSCA needs to initiate a
task under the case type PP-CAT.
30.2 Workflow
MSCA initiated > EVL
30.3 Application requirements
Conditions to cancel a parallel trade permit need to be met.
30.4 Steps to be followed by the MSCA
Step 1: Choose the asset to be cancelled and select the PP-CAT action. This will create a
task (with a case number) that you can find in the task tab. Claim the task
“Evaluate & Decide“.
Step 2: Inform the permit holder giving the opportunity to comment in 30 days using ad
hoc communication (see section 3.12)
Step 3: Decide on the withdrawal of the parallel trade permit under Task details in R4BP
3 (see section 3.14).
Step 4: Complete the “Evaluate & Decide” task (Figure 22) by selecting “Approve” or “Do
not approve”.
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31. SA-APP National authorisation – simplified procedure
31.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
31.2 Workflow
BRC > MAA > EVL
31.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
31.4 Steps to be followed by the MSCA
Step 1: Claim the “MSCA accept” task.
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the
applicant via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see
section 3.13).
Step 3: Complete the actions in the “MSCA accept” page (Figure 18).
Check in your national invoicing system whether the fee has been paid within 30
days (3a) or not (3b).
a. If the fee has been paid, accept and proceed with Step 4.
b. If the fee has not been paid, reject the application (see section 3.14).
Step 4: Claim the ‘Evaluate & Decide’ task and complete the actions in the ‘Evaluate &
Decide’ page (Figure 22).
a. If you are satisfied that the product meets the conditions laid down in Article 25,
authorise the product within 90 days of the acceptance date. Grant the product
authorisation using the ‘approve application’ function (see section 3.14).
b. If you consider that the application is incomplete, inform the applicant of the
additional information that is required. Through ‘request additional information’
(see section 3.11) a resubmission task item for the applicant is created to submit
a new IUCLID 5 dossier. Through ad hoc communication with request for a reply
(see section 3.12), a task is created for which other files than IUCLID 5 dossiers
can be sent via R4BP 3.
Set a reasonable period for the submission of the additional information which
should normally not exceed 90 days. Authorise the product within 90 days of
receipt.
Reject the application if the applicant fails to submit the requested information by
the deadline (see section 3.14).
32. SA-BBS Simplified authorisation of the same biocidal
product (authorised)
32.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
32.2 Workflow
BRC > MAA > VAL > EVL
32.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
32.4 Steps to be followed by the MSCA
Please follow the same steps of chapter 16.3.1.
33. SA-BBP Simplified authorisation of the same biocidal product (pending)
33.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
33.2 Workflow
BRC > MAA > VAL > EVL
33.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
33.4 Steps to be followed by the MSCA
In the simplified authorisation of the same biocidal product (pending) procedure, an
applicant submitted an application for a simplified product authorisation (the reference
product) to the Member States, creating the reference case. Other application(s) are
submitted for the simplified authorisation of one or more same biocidal product(s). When
the reference product is authorised the simplified authorisation of the same biocidal
product(s) can be granted. Since the process is not automated the MSCA needs to follow
the finalisation of the reference case and continue with the (pending) process as soon as
the authorisation of the reference product is granted. Until finalisation of the reference
product authorisation, the authorisation of the same biocidal product cannot be granted.
Please follow steps 1-3 of chapter 16.3.1. When a decision is made with regard to the
authorisation of the reference product, you can proceed with step 4, 5 and 6 of chapter
12.3.1. Please ensure that the decision on authorisation is sent within 60 days from the
date of the decision concerning the related reference product.
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34. SA-CAT Cancellation of simplified authorisation
34.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
34.2 Workflow
MSCA initiated > EVL
34.3 Application requirements
An existing simplified authorisation needs to be cancelled based on one of the following
considerations:
the conditions referred to in Article 25 are not (longer) satisfied; or
the authorisation was granted on the basis of false or misleading information; or
the authorisation holder has failed to comply with its obligations under the
authorisation or under the BPR.
34.4 Steps to be followed by the MSCA
Step 1: Choose the asset to be cancelled and select the SA-CAT action. This will create a
task (with a case number) that you can find in the task tab. Claim the task
“Evaluate & Decide“.
Step 2: Inform the simplified authorisation holder giving the opportunity to comment in
30 days using ad hoc communication (see section 3.12)
Step 3: Decide on the cancellation of the authorisation under Task details in R4BP 3 (see
section 3.14).
Step 4: Complete the “Evaluate & Decide” task (Figure 22) by selecting “Approve” or “Do
not approve”.
Step 5: Notify the simplified authorisation holder, the Commission and all other MSCAs
of the decision taken using ad hoc communication (see section 3.12)
Step 6: In case notifications in other MSCA need to be cancelled, each cCA must contact
the ECHA Helpdesk.
35. SA-AAT Amendment of simplified authorisation
35.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
35.2 Workflow
MSCA initiated > EVL
35.3 Application requirements
An existing national authorisation needs to be amended based on one of the following
situations:
the conditions referred to in Article 25 are not (longer) fully satisfied; or
the authorisation was granted on the basis of false or misleading information; or
the authorisation holder has failed to comply with its obligations under the
authorisation or under the BPR.
35.4 Steps to be followed by the MSCA
Step 1: Choose the asset to be amended and select the SA-AAT action. This will create a
task (with a case number) that you can find in the task tab. Claim the task
“Evaluate & Decide“.
Step 2: Inform the simplified authorisation holder giving the opportunity to comment in
30 days using ad hoc communication (see section 3.12)
Step 3: Decide on the amendment of the authorisation under Task details in R4BP 3 (see
section 3.14).
Step 4: Complete the “Evaluate & Decide” task (Figure 22) by selecting “Approve” or “Do
not approve”.
Step 5: Notify the simplified authorisation holder, the Commission and all other MSCAs
of the decision taken using ad hoc communication (see section 3.12)
Step 6: In case notifications in other MSCAs need to be amended, the applicant should
be required to submit new notifications through SN-NOT.
36. SA-ADC Simplified authorisation administrative change on request
36.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
36.2 Workflow
BRC > EVL
36.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
36.4 Steps to be followed by the MSCA
Step 1: Claim the “Evaluate & Decide” task.
Step 2: Complete the actions in the “Evaluate & Decide” page (Figure 22) by checking
whether the submitted information is complete and correct and amend the
authorisation of the biocidal product in conformity with the agreed change.
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Step 3: Approve the application (see section 3.14) and upload the amended SPC to
R4BP 3.
Step 4: Reject the notification if the submitted information is incomplete or/and
incorrect (see section 3.14).
36.5 Supporting documents
Template rejection of an application.
37. SA-TRS Transfer of a simplified authorisation
37.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
37.2 Workflow
BRC > EVL
37.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
37.4 Steps to be followed by the MSCA
Step 1: Claim the “Evaluate & Decide” task.
Step 2: Complete the actions in the “Evaluate & Decide” page (Figure 22) by checking
whether the submitted information is complete and correct and amend the
authorisation of the biocidal product in conformity with the agreed change.
Step 3: Approve the application (see section 3.14) and upload the amended SPC to
R4BP 3.
Step 4: Reject the transfer if the submitted information is incomplete or/and incorrect
(see section 3.14).
38. SA-MIC Simplified authorisation minor change on request
38.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
38.2 Workflow
BRC > MAA > EVL
38.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
38.4 Steps to be followed by the MSCA
Step 1: Claim the “MSCA accept” task.
Within 30 days following receipt of the notification, if you disagree with the
change or the relevant fee has not been paid, reject the case in R4BP 3 (see
section 3.14) and inform the applicant on the grounds for the rejection. Inform
the other cMSs also on the grounds for the rejection through ad hoc
communication in R4BP 3 (see section 3.12), using the template mentioned in
the supporting documents section below.
Step 2: Complete the actions in the “MSCA accept” page (Figure 18).
Step 3: Claim the “Evaluate & Decide” task (Figure 22).
Step 4: Complete the actions in the “Evaluate & Decide” page (Figure 22) by amending
the simplify authorisation of the biocidal product in conformity with the agreed
change. Approve the case (see section 3.14) and upload the amended SPC to
R4BP 3.
Step 5: Notify other MSCA (cMS) of the decision taken using ad hoc communication
(see section 3.12).
Step 6: In case notifications in other MSCAs need to be amended, the applicant should
be required to submit new notifications through SN-NOT.
38.5 Supporting documents
Template rejection of an application.
39. SA-MAC Simplified authorisation major change on request
39.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
39.2 Workflow
BRC > MAA > EVL
39.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
39.4 Steps to be followed by the MSCA
Step 1: Claim the “MSCA accept” task.
Within 30 days following receipt of the notification, if you disagree with the
change or the relevant fee has not been paid, reject the case in R4BP 3 (see
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section 3.14) and inform the applicant on the grounds for the rejection. Inform
the other cMSs also on the grounds for the rejection through ad hoc
communication in R4BP 3 (see section 3.12), using the template mentioned in
the supporting documents section below.
Step 2: Complete the actions in the “MSCA accept” page (Figure 18).
Step 3: Claim the “Evaluate & Decide” task.
Step 4: Complete the actions in the “Evaluate & Decide” page (Figure 22) by amending
the authorisation of the biocidal product in conformity with the agreed change.
Approve the case (see section 3.14) and upload the amended SPC to R4BP 3.
Step 5: Notify other MSCA (cMS) of the decision taken using ad hoc communication
(see section 3.12).
Step 6: In case notifications in other MSCAs need to be amended, the applicant should
be required to submit new notifications through SN-NOT.
39.5 Supporting documents
Template rejection of an application.
40. SA-NPF Notification of product in product family for simplified authorisation
40.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
40.2 Workflow
BRC > EVL
40.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
40.4 Steps to be followed by the MSCA
Step 1: Claim the “Evaluate & Decide” task.
Step 2: If the submitted information is correct, go to Step 3 or request further
information otherwise (see section 3.11).
Step 3: Accept the notification or reject it if the submitted information is still incorrect or
incomplete (see section 3.14).
41. SE-NOT Notification of unexpected or adverse effect for
SA
41.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
41.2 Workflow
BRC > EVL
41.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
41.4 Steps to be followed by the MSCA
Step 1: Claim the “Evaluate & Decide” task (Figure 22).
Step 2: If the submitted information is correct, go to Step 3 or request further
information otherwise (see section 3.11).
Step 3: Accept the notification or reject it if the submitted information is still incorrect or
incomplete (see section 3.14).
42. SN-NOT Notification for placing on the market - simplified procedure
42.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
42.2 Workflow
BRC > EVL
42.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
42.4 Steps to be followed by the MSCA
Step 1: Claim the “Evaluate & Decide” task (Figure 22).
Step 2: If the submitted information is correct, go to Step 3 or request further
information otherwise (see section 3.11).
Step 3: Accept the notification or reject it if the submitted information is still incorrect or
incomplete (see section 3.14).
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43. UA-APP Union authorisation
43.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
43.2 Workflow
BRC > EAA > VAL > MEV > OPN > DEC
43.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
43.4 Steps to be followed by the MSCA
The eCA needs to claim the task during the authorisation process and can request further
information through the task item.
Step 1: Claim the ‘Validation’ task.
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the
applicant via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see
section 3.13). If the fee is not paid within 30 days, reject the application. Inform
ECHA of the rejection and ask to close the case via ad hoc communication in
R4BP 3 (see section 3.12). Once the application is closed the applicant will be
automatically notified.
Step 3: Complete the actions in the ‘Validation’ page (Figure 20).
Validate the application within 30 days after receiving the task from ECHA
according to BPR Article 43(3). The validation includes verifying whether the
information requirements for biocidal products are fulfilled.
The validation shall not include an assessment of the quality or adequacy of the
data or justifications submitted.
a. If the information requirements are fulfilled, complete the validation task and
follow on with Step 4.
b. If the information requirements described above are not fulfilled, inform the
applicant what additional information is required for validating the application.
Use ‘Request additional information’ (see section 3.11), if you require a new
IUCLID 5 dossier Set a reasonable time limit for the submission of the additional
information. This shall normally not exceed 90 days.
c. Validate the application within 30 days of receipt of the additional information in
R4BP 3. Reject the application if the applicant fails to submit the requested
information within the deadline or the information requirements remain
incomplete. The applicant (case owner) will be automatically notified. Inform
ECHA of the rejection through ad hoc communication in R4BP 3 (see section
3.12). Part of the fees paid by the applicant to the eCA may need to be
reimbursed.
Step 1: Claim the “Evaluate” task and complete the actions in the “Evaluation” page
(Figure 21).
Evaluate the application within 365 days (BPR Article 44(1)). The following tasks
related to R4BP 3 can be considered during the evaluation:
a. Annotate IUCLID 5 file1 where relevant.
b. Consult with ECHA via ad hoc communication if additional information is required.
For ‘stop the clock’ requests request additional information as described in Step
3.
c. Inform ECHA via ad hoc communication (see section 3.12) as soon as possible on
issues identified that may need to be discussed at a working group meeting
already before submitting the PAR and the dossier enters the peer review phase.
d. Perform a confidentiality claims check by evaluating the justifications submitted
by the applicant (this step is not yet agreed by all the MSCA).
Step 2: ECHA suggests that no later than 60 days before the end of the 365-day
evaluation period the eCA sends the PAR and the draft SPC to the applicant for a
30-day commenting period. Reply to the applicant’s comments and adapt the
PAR and draft SPC accordingly if necessary.
Step 3: Send the PAR, the draft SPC and Response to Comments (RCOM) table to ECHA
for initiation of the peer review stage.
The peer review stage that follows Step 6 is described in the working procedures
for evaluating an application for Union authorisation as explained in section 43.1.
43.5 Supporting documents
Template agreement to act as CA.
44. UA-APP (WA) Provisional Union authorisation
44.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
44.2 Workflow
BRC > EAA > VAL > MEV > OPN > DEC
44.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
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44.4 Steps to be followed by the MSCA
The eCA needs to claim the task during the authorisation process and can request further
information through the task item.
Step 1: Claim the ‘Validation’ task.
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the
applicant via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see
section 3.13). If the fee is not paid within 30 days, reject the application. Inform
ECHA of the rejection and ask to close the case via ad hoc communication in
R4BP 3 (see section 3.12). Once the application is closed the applicant will be
automatically notified.
Step 3: Complete the actions in the ‘Validation’ page (Figure 20).
Validate the application within 30 days after receiving the task from ECHA according to
BPR Article 43(3). The validation includes verifying whether the information requirements
for biocidal products are fulfilled and that the evaluating competent authority has given a
positive opinion in the CAR (please check the CAR uploaded in the CIRCA BC page under
the new active folders)
The validation shall not include an assessment of the quality or adequacy of the data or
justifications submitted.
d. If the information requirements are fulfilled, complete the validation task and
follow on with Step 4.
e. If the information requirements described above are not fulfilled, inform the
applicant what additional information is required for validating the application.
Use ‘Request additional information’ (see section 3.11), if you require a new
IUCLID 5 dossier Set a reasonable time limit for the submission of the additional
information. This shall normally not exceed 90 days.
f. Validate the application within 30 days of receipt of the additional information in
R4BP 3. Reject the application if the applicant fails to submit the requested
information within the deadline or the information requirements remain
incomplete. The applicant (case owner) will be automatically notified. Inform
ECHA of the rejection through ad hoc communication in R4BP 3 (see section
3.12). Part of the fees paid by the applicant to the eCA may need to be
reimbursed.
Step 4: Claim the “Evaluate” task and complete the actions in the “Evaluation” page
(Figure 21).
Evaluate the application within 365 days (BPR Article 44(1)). The following tasks
related to R4BP 3 can be considered during the evaluation:
e. Annotate IUCLID 5 file1 where relevant.
f. Consult with ECHA via ad hoc communication if additional information is required.
For ‘stop the clock’ requests request additional information as described in Step
3.
g. Inform ECHA via ad hoc communication (see section 3.12) as soon as possible on
issues identified that may need to be discussed at a working group meeting
already before submitting the PAR and the dossier enters the peer review phase.
h. Perform a confidentiality claims check by evaluating the justifications submitted
by the applicant (this step is not yet agreed by all the MSCA).
Step 5: ECHA suggests that no later than 60 days before the end of the 365-day
evaluation period the eCA sends the PAR and the draft SPC to the applicant for a
30-day commenting period. Reply to the applicant’s comments and adapt the
PAR and draft SPC accordingly if necessary.
Step 6: Send the PAR, the draft SPC and Response to Comments (RCOM) table to ECHA
for initiation of the peer review stage.
The peer review stage that follows Step 6 is described in the working procedures for
evaluating an application for Union authorisation as explained in section 43.1.
44.5 Supporting documents
Template agreement to act as CA.
EUROPEAN CHEMICALS AGENCY
ANNANKATU 18, P.O. BOX 400,
FI-00121 HELSINKI, FINLAND
ECHA.EUROPA.EU