EU IG Version 1 Comparison between xEVMPD and IDMP ... · EU IG v2 will contain the operating model...

EU IG Version 1

Comparison between xEVMPD

and IDMP requirements

Remco Munnik

Associate Director IPERION® Life Sciences Consultancy

20+ years experience in Life Science and Regulatory Affairs,

10+ years consultancy with focus on Regulatory Information

Management (RIM) and electronic submissions.

➢ Subject Matter Expert for Regulatory Information

Management systems (RIM), eCTD, xEVMPD and ISO IDMP

➢ Member of EMA ISO IDMP Task Force, Chapter 2 Focus

Group, Organizations and Products

➢ Chair Medicines for Europe Telematics group

Strategy, eAF, eCTD, CESP, xEVMPD and ISO IDMP

2Confidential – IPERION® 2020

ISO IDMP

Confidential – IPERION® 2020 3

ISO: International Organization for Standardization is an independent, non-governmental

organization, the members of which are the standards organizations of the 164 member

countries.

IDMP: a set of 5 ISO norms which has been developed in response to a worldwide demand

for internationally harmonized specifications for medicinal products. It…

• provides structured medicinal, pharmaceutical product and substance data models

• provides mechanisms to uniquely identify products and its components

• is the only global standard for medicinal product information

• is applicable to industry and regulators

EMA published EU Implementation Guide Version 1 – February 2020

11 February 2020: EMA published the EU ISO IDMP Implementation Guide version 1

Introduction Introduction, legal basis and scope of the EU IG for implementation of ISO IDMP

Chapter 1 Pre-registration requirements

Guidance on how to get access to SPOR and what to do prior to submission

Chapter 2 Initial submission

Guidance on which medicinal product information (data fields and business

rules) shall be submitted

Chapter 3 Maintenance (not included in EU IG v1)

Chapter 4 Data quality assurance (not included in EU IG v1)

Chapter 5 Data access/export (not included in EU IG v1)

Chapter 6 Technical specifications on structure and format

Technical specifications for the API, contains description of principles, security,

resources, calls, end-points

Chapter 7 Migration guide

Migration rules between xEVMPD and PMS including backwards

compatibility rules.

Chapter 8 Examples (not included in EU IG v1)

Confidential – IPERION® 2020

https://www.ema.europa.eu/en/human-regulatory/research-development/data-medicines-iso-idmp-standards/spor-master-data/substances-products-data-management-services

EMA published EU Implementation Guide

During review cycle, EMA received more than 2.100 comments on the EU IG

– More than what EMA expected – need time for resolution

Finalised end 2019. Delay in final publication due to agreement from ISO to use screenshots and

references to the ISO documentation.


About Version 1

EU IG v1 is process agnostic and does not contain information on the process for submission, exchange

or validation of medicinal product information. EU IG v2 will contain the operating model for PMS.

Although the business rules, data fields and specification presented in EU IG v1 are expected to be

stable, they may be subject to modification as part of publication of EU IG v2.

The specification of the SPOR API, as reflected in 'Chapter 6 – Technical specs on structure and Format'

is subject to development and testing. As with any software it may evolve over time and will be subject

to change control.

Both this guide and the API can be expected to evolve with understanding of business processes and

requirements and application of technological improvements, although no significant changes are

expected.

EU IG v1 promotes awareness and transparency of the work of the SPOR (ISO IDMP) Task Force.

Stakeholders can use the available information to anticipate impacts and future workload. However, EMA

encourages stakeholders to be cautious when using the information in this document to define any

software development or major investment, and to ensure that modifications may be implemented in their

systems in the future.


https://www.ema.europa.eu/en/human-regulatory/research-development/data-medicines-iso-idmp-standards/spor-master-data/spor-iso-idmp-task-force

IhaveaDreaMP

Submission of

structured data

with documents

to support the

data

Assessment of

structured dataApproved

data stored

in EU-

database

Patients can

access real-

time

approved

data

TOM PMS

EU IDMP/SPOR Task Force

Iperion presented at the EU

IDMP / SPOR Task Force


Chapter 1

Pre-registration requirements

Guidance on how to get access to SPOR and what to do prior to submission

This first chapter provides guidance on how to get access to SPOR.

• Register for an account

• Allows your company to utilize the available service within the SPOR database

• In the meantime, it is important to make sure all the relevant Organizations and

Referentials that you use are readily available and/or updated within SPOR for the

initial submissions

• Optional mapping of the SPOR data to your internal systems.


https://register.ema.europa.eu/identityiq/login.jsf?prompt=true

Chapter 2

Initial submission

Guidance on which medicinal product information (data fields and business rules)

shall be submitted

• Chapter 2 outlines the data elements are required for the initial submission of

medicinal products, as well as how that information should be captured in according to

ISO IDMP standards.

• Companies should get familiar with the IDMP data requirements and review internal

sources in which data are stored and the processes in which the data is generated,

used and updated.

• Today’s webinar focus to present the data elements that are “new” compared to the

requirements in xEVMPD


Chapter 6

Technical specifications on structure and format

Technical specifications for the API, contains description of principles, security,

resources, calls, end-points

• For companies that wish to integrate their local systems to SPOR, chapter 6 provides

the technical specifications for the Application Programming Interface (API).

• The technical mechanism for product information management is a RESTful API

known as the SPOR API. The recommendation is to first read the API specifications

titled “SPOR API v2 Specification to get a better understanding of the tools available.


https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/substances-products-organisations-referentials-spor-spor-api-v2-specification_en.pdf

Chapter 7

Migration guide

Migration rules between xEVMPD and PMS including backwards compatibility

rules

• Outlines the rules governing the migration and the approach to be followed by EMA for

the migration of data from XEVMPD to PMS (including a back loop from PMS to

XEVMPD).

• This chapter is provided purely for information sharing and transparency, as there is

no required action for industry to implement the same approach for their own local

systems.

• However, if you are currently looking implementing a new information management

systems to capture your product data that is compatible with IDMP, you may want to

take a similar if not the same approach as EMA to migrate your XEVMPD data to the

new system.


From xEVMPD to ISO IDMP


xEVMPD vs IDMP


EU ISO IDMP implementation timelines

Publication EU IG

v2Optional

ISO IDMP

Mandatory

ISO IDMP

24 months implementation window

It.1

Feb-20

12

months

Publication EU IG

v1

Q4-20 Q4-21 Q4-22

12

months


EU IG v1


Data element Data element Data element Data element

1. Medicinal product 1.14. Contact (QPPV) 2.7. International birth date 6.4. Marketing status

1.1. Medicinal product identifier (MPID) 1.14.1. Identifier2.8. Marketing Authorisation Holder

(Organisation)6.4.1. Country

1.2. Domain 1.14.2. Role 2.9. (Marketing Authorisation) Regulator 6.4.2. Marketing Status

1.3. Type 1.15. Pharmacovigilance enquiry information 2.10. Marketing authorisation procedure 6.4.3. (Marketing Status) date Start date

1.4. Combined pharmaceutical dose

form1.15.1. Email address 2.10.1. Procedure Identifier 6.4.4. (Marketing Status) date Stop date

1.5. Legal status of supply 1.15.2. Phone number 2.10.2. Procedure Type 6.5. Marketing Authorisation (Package level)

1.6. Additional monitoring indicator 1.15.3. Role 2.10.3. Procedure Date (period) start 6.5.1. Regulatory Authorisation Type

1.7. Orphan Designation Status 1.16. Attached Document 2.10.4. Procedure Date (period) end6.5.2. Marketing Authorisation Number (Package

level)

1.7.1. Regulatory Authorisation Type 1.16.1. (Attached Document) Identifier (master)2.10.5. Marketing authorisation

application6.5.3. Country

1.7.2. Orphan designation status 1.16.2. Alternative (Attached Document) Identifier 3. Therapeutic (product) Indication 6.5.4. Authorisation status

1.7.3. Orphan designation number 1.16.3. (Attached Document) Type3.1. Indication as

"Disease/Symptom/Procedure"

6.5.5. Authorisation status date (Package Medicinal

Product)

1.7.4. Orphan designation status

date1.16.4. (Attached Document) Effective Date 3.2. Co-morbidity 6.6. Packaged item (container)

1.7.5. Orphan designation Validaty

period1.16.5. (Attached Document) Language 3.3. Intended effect 6.6.1. Package item (container) type

1.8. Paediatric use indicator 1.17. Product cross-reference 4. Pharmaceutical product 6.6.2. Package item reference(s)

1.9. Full Indication text 1.17.1. Reference product type 4.1. Administrable Dose Form 6.6.3. Manufactured item reference(s)

1.9.1. Language 1.17.2. Product Cross-Reference 4.2. Unit of Presentation 6.6.4. Device reference(s)

1.10. EURD ID 1.18. Manufacturing Business Operation 4.3. Ingredient 6.6.5. Package item (container) quantity

1.11. Product classification 1.18.1. Manufacturer 4.4. Device 6.6.6. Data carrier identifier

1.11.1. XEVMPD product type

information1.18.2. Operation type 4.5. Route of Administration 6.6.7. Material

1.11.2. Legal basis 1.18.3. Manufacturer operation start date 5. Ingredient 6.7. Package (component)

1.11.3. ATC Code(s) 1.18.4. Manufacturer operation stop date 5.1. Ingredient role 6.7.1. Component type

1.11.4. Medicinal product category 1.18.5. Confidentiality indicator 5.2. Manufacturer 6.7.2. Component material

1.12. Medicinal product name 1.18.6. Manufacturer Authorisation Reference Number 5.3. Substance 6.8. Device

1.12.1. Full name 1.18.7. Effective date 5.3.1. Substance 6.8.1. Device type

1.12.2. Country/ Language1.18.8. (Manufacturing Business Operation) Medicines Regulatory Agency

Organisation5.3.2. Strength (quantative composition) 6.8.2. Device identifier

1.12.3. (Medicinal Product name)

name part(s)2. Marketing authorisation information 5.3.3. Reference Strength 6.8.3. Device trade name

1.13. (Pharmacovigilance) Master file 2.1. Regulatory Authorisation Type 6. Packaged medicinal product 6.9. Manufactured item

1.13.1. File type 2.2. Marketing Authorisation Number6.1. Packaged Medicinal Product Indentifier

PCID6.9.1. Unit of presentation

1.13.2. File code 2.3. Country 6.2. Package description 6.9.2. Manufactured item quantity

2.4. Authorisation status 6.2.1. Language 6.9.3. Manufactured dose form

2.5. Authorisation status date 6.3. Legal status of supply 6.9.5. Ingredient

2.6. Date of first authorisation 6.10. Shelf Life / Storage

6.10.1. Shelf Life Type

6.10.2. Shelf Life Time Period and Units

6.10.3. Special Precautions for Storage


PMS ID


Why is a PMS ID needed?

• MPIDs and PCIDs consist of a number of elements (e.g. marketing authorisation holder, legal status

for MPIDs or package item container for PCIDs) that may change during the lifecycle of the product

resulting in an updated MPID or PCID as applicable linked to regulatory activities during the lifecycle of

the medicinal product.

• PMS ID remains stable since the initial submission and throughout the lifecycle of the product

including all post-authorisation activities. PMS ID is linked to regulatory procedure numbers.

• PMS ID will be associated to the MPID concept but will also be associated (within the PMS system)

with all previous inactive MPIDs where MPIDs changed during the lifecycle of the medicinal product.

NOTE: This point is currently under discussion and further clarity will be introduced as part of

EU IG v2.

• PMS ID may have one or multiple packaged medicinal product (presentations) associated which are

identified by the PCID.


Submission Procedure/application

number

PMS ID MPID Packs PCIDs

Initial MAA EMEA/H/C/000XXX/000 5005 EU-5005100000396-001 Blister (alu) 1 tablet

Blister (alu) 5 tablets

EU-5005100000396-001-001

EU-5005100000396-001-002

Addition of new

manufacturer

EMEA/H/C/000XXX/IB/001 5005 EU-5005100000396-002 Blister (alu) 1 tablet


EU-5005100000396-002-001

EU-5005100000396-002-002

Transfer of MA EMEA/H/C/000XXX/T/002 5005 EU-5005100000497-003 Blister (alu) 1 tablet


EU-5005100000497-003-001

EU-5005100000497-003-002

Change of

primary

packaging

EMEA/H/C/000XXX/IB/003 5005 EU-5005100000497-003 Blister (alu) 1 tablet


EU-5005100000497-003-003

EU-5005100000497-003-004

Change in legal

status

EMEA/H/C/000XXX/II/004 5005 EU-5005100000497-004 Blister (alu) 1 tablet


EU-5005100000497-003-003

EU-5005100000497-003-004


Introduction of a PMS medicinal product set ID

• A medicinal product single entry in Product Management Service (PMS) is defined by a set of

characteristics that defines a medicinal product as a single unique entry in PMS database. This entry

is subject to versioning and aligns with the regulatory status of the product during its lifecycle.

• Each individual medicinal product entry is assigned a single PMS identifier that remains unchanged

through the lifecycle of the medicinal product. PMS stable ID is a supplementary stable ID to any

existing authorisation number as assigned by an authorising body.

• The defining characteristics of each single medicinal product entry in PMS (associated to each PMS

ID) includes:

• Country (Note: EU in the case of Centralised Authorised Products)

• Active substance (or group of active substances contained in the same medicinal product)

• Pharmaceutical form

• Medicinal product strength

• Product name: (including all different names associated to the same global marketing

authorisation).

• Focus group Chapter 2 discussion: Need for rule to separate duplicates (registration procedure)


New fields EU IG vs xEVMPD data


Data element Data element Data element Data element

1. Medicinal product 1.14. Contact (QPPV) 2.7. International birth date 6.4. Marketing status

1.1. Medicinal product identifier (MPID) 1.14.1. Identifier2.8. Marketing Authorisation Holder

(Organisation)6.4.1. Country

1.2. Domain 1.14.2. Role 2.9. (Marketing Authorisation) Regulator 6.4.2. Marketing Status

1.3. Type 1.15. Pharmacovigilance enquiry information 2.10. Marketing authorisation procedure 6.4.3. (Marketing Status) date Start date

1.4. Combined pharmaceutical dose

form1.15.1. Email address 2.10.1. Procedure Identifier 6.4.4. (Marketing Status) date Stop date

1.5. Legal status of supply 1.15.2. Phone number 2.10.2. Procedure Type 6.5. Marketing Authorisation (Package level)

1.6. Additional monitoring indicator 1.15.3. Role 2.10.3. Procedure Date (period) start 6.5.1. Regulatory Authorisation Type

1.7. Orphan Designation Status 1.16. Attached Document 2.10.4. Procedure Date (period) end6.5.2. Marketing Authorisation Number (Package

level)

1.7.1. Regulatory Authorisation Type 1.16.1. (Attached Document) Identifier (master)2.10.5. Regulatory authorisation

application6.5.3. Country

1.7.2. Orphan designation status 1.16.2. Alternative (Attached Document) Identifier 3. Therapeutic (product) Indication 6.5.4. Authorisation status

1.7.3. Orphan designation number 1.16.3. (Attached Document) Type3.1. Indication as

"Disease/Symptom/Procedure"

6.5.5. Authorisation status date (Package Medicinal

Product)

1.7.4. Orphan designation status

date1.16.4. (Attached Document) Effective Date 3.2. Co-morbidity 6.6. Packaged item (container)

1.7.5. Orphan designation Validaty

period1.16.5. (Attached Document) Language 3.3. Intended effect 6.6.1. Package item (container) type

1.8. Paediatric use indicator 1.17. Product cross-reference 4. Pharmaceutical product 6.6.2. Package item reference(s)

1.9. Full Indication text 1.17.1. Reference product type 4.1. Administrable Dose Form 6.6.3. Manufactured item reference(s)

1.9.1. Language 1.17.2. Product Cross-Reference 4.2. Unit of Presentation 6.6.4. Device reference(s)

1.10. EURD ID 1.18. Manufacturing Business Operation 4.3. Ingredient 6.6.5. Package item (container) quantity

1.11. Product classification 1.18.1. Manufacturer 4.4. Device 6.6.6. Data carrier identifier

1.11.1. XEVMPD product type

information1.18.2. Operation type 4.5. Route of Administration 6.6.7. Material

1.11.2. Legal basis 1.18.3. Manufacturer operation start date 5. Ingredient 6.7. Package (component)

1.11.3. ATC Code(s) 1.18.4. Manufacturer operation stop date 5.1. Ingredient role 6.7.1. Component type

1.11.4. Medicinal product category 1.18.5. Confidentiality indicator 5.2. Manufacturer 6.7.2. Component material

1.12. Medicinal product name 1.18.6. Manufacturer Authorisation Reference Number 5.3. Substance 6.8. Device

1.12.1. Full name 1.18.7. Effective date 5.3.1. Substance 6.8.1. Device type

1.12.2. Country/ Language1.18.8. (Manufacturing Business Operation) Medicines Regulatory Agency

Organisation5.3.2. Strength (quantative composition) 6.8.2. Device identifier

1.12.3. (Medicinal Product name)

name part(s)2. Marketing authorisation information 5.3.3. Reference Strength 6.8.3. Device trade name

1.13. (Pharmacovigilance) Master file 2.1. Regulatory Authorisation Type 6. Packaged medicinal product 6.9. Manufactured item

1.13.1. File type 2.2. Marketing Authorisation Number6.1. Packaged Medicinal Product Indentifier

PCID6.9.1. Unit of presentation

1.13.2. File code 2.3. Country 6.2. Package description 6.9.2. Manufactured item quantity

2.4. Authorisation status 6.2.1. Language 6.9.3. Manufactured dose form

2.5. Authorisation status date 6.3. Legal status of supply 6.9.4. Ingredient

2.6. Date of first authorisation 6.10. Shelf Life / Storage




1.4 Combined pharmaceutical dose form

'Powder' and 'solvent' are two manufactured items that must be combined to create

a single pharmaceutical product. The administrable dose form that will be created

using these two manufactured items and administered to the patient will be 'solution

for injection'. The combined pharmaceutical dose form to be used in this case is the

standard term ‘Powder and solvent for solution for injection’.

“Film-coated tablet” involves a single manufactured item. This manufactured item

corresponds with the administrable dose form (no previous preparation/combination

with other manufactured item is needed).

Therefore, this field should be left blank.

“Oral Capsule” & “External Cream” correspond with two different administrable dose

forms which do not need combining for administering to the patient. Therefore, this

field should be left blank.

+ =

&


1.8 Pediatric indication

In xEVMPD, an entry needs to be made in the “comment field”: This medicinal product is authorised for

the use in children.

In IDMP, a separate field will be available to trace this information ☺

1. Example 1: information of paediatric use included in section 4.1 of the SmPC

• Section 4.1 Therapeutic indications of the SmPC states: Levetiracetam ProductXYZ is indicated as monotherapy in the

treatment of partial onset seizures in adults and adolescents from 16 years of age with newly diagnosed epilepsy.

2. Example 2: information of paediatric use not reflected in section 4.1 of the SmPC but included in section 4.2 of the SmPC

• Section 4.2 Posology and method of administration of the SmPC states:

Posology

Monotherapy for adults and adolescents from 16 years of age.

A dedicated SPOR RMS List will be created to include the Paediatric use indicator List with the following

values.

• medicinal product authorised for paediatric use

• medicinal product not authorised for paediatric use


1.9 Full Indication text

Centrally authorised products (CAPs):

Only the English version of the full indication text is mandatory to be submitted.

Nationally authorised products (NAPs) including products registered through the Mutual Recognition

(MRP), Decentralised (DCP) and National procedures (NP):

• The text must be provided in the national language, as authorised by the Competent Authority and as

stated in section 4.1 Therapeutic Indications of the corresponding SmPC. Provision of additional

translation in English is on optional basis.

• In countries with multiple languages (e.g. Belgium) the full therapeutic indication of at least one local

language is mandatory. Submissions in other official local languages or in English are optional.


1.9 Full Indication text

How to technically handle huge

amount of text into one single field

1.10 EURD ID

Since 1 April 2013, the European Medicines Agency have started carrying out

single assessments of periodic safety update reports (PSURs) of active

substances contained in both centrally (CAPs) and nationally authorised

medicines (NAPs).

The new single assessment means that the Agency analyses all reports for

medicines containing an active substance, for all types of marketing

authorisation and for medicines authorised in more than one Member State.

It aims to harmonise and strengthen the safety and benefit-risk review of

medicines across the European Economic Area.

To assist with this harmonised assessment, in October 2012 the Agency

published a list of EU reference dates and frequency of submission of PSURs for

active substances contained in medicines in the EU, known as the 'EURD list'.

Marketing-authorisation holders are required to submit PSURs to national

competent authorities and the Agency according to the dates published in this

list.

Beneficial to link substance information to EURD ID?


https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/periodic-safety-update-reports

1.12.3 (Medicinal Product name) name part(s)

xEVMPD ISO IDMP

• Short,

• Generic,

• MAH,

• Dosage form

• Strength of name

• Invented name part

• Scientific name part

• Strength part

• Pharmaceutical dose form part

• Formulation part

• Intended use part

• Target population part

• Container or pack part

• Device part

• Trademark or company name part

• Time/period part

• Flavour part


1.16 Attached document

In xEVMPD only SmPC, for IDMP Iteration 1, also eAF, 3.2.S.2.1, 3.2.P.1 and 3.2.P.3.1 requested.

To be discussed for version 2 and in relation to TOM.

If NCAs assess data and document during regulatory procedure, no need to submit this data.

In addition, the following documents from module 1 and module 3 of the Common Technical Dossier

(CTD) dossier must be included where available (e.g. initial submissions, changes in the composition of

the medicinal product, changes/introductions of manufacturers of the finished product or active substance)

• Module 1.2 – Electronic Application form (eAF) (The eAF is the only document in Module 1.2 required,

to be provided where relevant)

• Module 3.2.S.2.1 Manufacturer(s) (name, dosage form)

• Module 3.2.P.1 Description and Composition of the Drug Product (name, dosage form)

• Module 3.2.P.3.1 Manufacturer(s) (name, dosage form)

The allowed file types for printed product information (i.e. SmPC/PL/marketing authorisation decision) and

module 3 of the CTD dossier are: .PDF (1), .DOC (2), .DOCX (3).


1.17 Product cross-reference

The section applies to the following scenarios:

1. If a medicinal product has been authorised under the following legal basis (or equivalent previous

legislation):

• Generic application (Article 10(1) of Directive No 2001/83/EC)

• Hybrid application (Article 10(3) of Directive No 2001/83/EC)

• Similar biological application (Article 10(4) of Directive No 2001/83/EC)

• Informed consent application (Article 10(c) of Directive No 2001/83/EC)

In addition, duplicate applications of any legal basis submitted under Article 82(1) of Regulation (EC)

No 726/2004 should also cross-reference.

the PMS ID of the innovator medicinal product should be provided.

2. If a medicinal product is Parallel Distributed or an Imported medicinal product (based on Article 76(3) and (4) of

Directive No 2001/83/EC), the PMS ID of the following related products may be provided as follows (NOTE: This

point is currently under discussion and further clarity will be introduced as part of EU IG v2.):

• Source product: medicinal product authorised in a different country acting as source of the imported medicinal product in

the destination country.

• Direct imported product: medicinal product already authorised in the destination country and which serves as a reference

for the parallel imported product intended to be imported into the destination country.


1.17.1 Product cross-reference type

1.17.2 Product Cross-Reference resource identifier

1.17.1

If applicable, the type of medicinal product that is referenced must be specified as a term ID.

• [List to be created in RMS (such as transferred MP, innovator of generic/biosimilar) ]

Example(s):

e.g. Generic, Biosimilar, Parallel Imported

1.17.2

The PMS ID of the medicinal product that is referenced shall be provided.

This applies to products under specific legal basis (e.g. Generic, Hybrid, Biosimilar)

Example(s):

• PMS ID – 5005

To check to not do this for legacy products


1.18 Manufacturing Business Operation

1.18.1. Manufacturer

1.18.2. Operation type

1.18.3. Manufacturer operation start date

1.18.4. Manufacturer operation stop date

1.18.5. Confidentiality indicator

1.18.6. Manufacturer Authorisation Reference Number

1.18.7. Effective date

1.18.8. (Manufacturing Business Operation) Medicines Regulatory Agency Organisation

Manufacturers to be included to optimize regulatory processes (see next slide)

However details to be discussed and agree.

What is the use of the historic data of manufacturers (see operation stop date). Manufacturers

that were previously used, are no longer relevant.


1.18 Manufacturer information - Data driven regulatory activities


Industry proposal to included Manufacturing information, in the assumption

that type IA variations for name/address changes of manufacturers can be

reported into the database (eleminate need for variations)


1.18.5 Confidentiality indicator

• Confidentiality indicator shows whether the manufacturing operation performed by a manufacturing

site is classified as confidential or public information. This information must be associated with a

manufacturing operation.

• Manufacturer information and its link to specific medicinal products that are included in the public

domain (e.g. batch release site, manufacturer of active substance for biological products) as mandated

by the current regulatory framework shall be classified as public/non-restricted information.

Remaining manufacturing operations are classified as confidential.

• Confidentiality is completed at the level of the manufacturing operations being performed by a given

manufacturer. E.g. Manufacturer ABCD may perform primary packaging and batch release operations

for a given product. In this case, the operation/activity batch release is specified as public information

whereas primary packaging is specified as confidential information.

Easier to set a flag automatically for the roles of Batch release site and manufacturer of active

substance for biological products to have not confidential and the other roles confidential?


2.7 International birth date

The date at which the very first marketing authorisation for a new medicinal product in any country in the

world was granted must be specified

Easier to link International birth date for originator and all generic applications/registrations?


2.6 Date of first authorisation

xEVMPD IDMP

Date of first authorisation/last renewal Date of first authorisation

Companies need to cross-check their xEVMPD data and RIM systems.


2.9 (Marketing Authorisation) Regulator

The regulator (RegulatedAuthorization.regulator) must be specified as an Identifier and following a

successful registration of organisation's information into the Organisation Management System (OMS

Most EU countries have one regulator agency. Maybe easier just to make exception for those

countries that have more than one (e.g. Germany with BfArM and PEI)?


2.10.3-4 Procedure Dates

• Procedure Date (period) start

The date when the marketing authorisation procedure started(submission of the procedure)may be

specified if available

• Procedure Date (period) end

The date when the marketing authorisation procedure was completed must be specified if available.

• For Centralised procedure, this date corresponds with the date of European Commission (EC) decision of the initial

marketing authorisation. If the medicinal product was registered through a line extension, the date of European

Commission (EC) decision of the related product with a different strength/pharmaceutical form must be selected.

• For Mutual recognition procedure, this date corresponds with the date of each National Competent Authority decision of

the initial marketing authorisation (date when the MA is granted).

• For Decentralised procedure, this date corresponds with the date of each National Competent Authority decision of the

initial marketing authorisation (date when the MA is granted).

• For National Procedures, this date corresponds with the date of National Competent Authority decision of the initial

marketing authorisation (date when the MA is granted)

NOTE: The inclusion on this data field currently under discussion and further clarity will be

introduced as part of EU IG v2

What to do for legacy products?


2.10.5 Regulatory application procedure

• Regulatory application procedure Identifier/Number

• Regulatory application procedure Type

• Regulatory application procedure End Date

TOM


3. Therapeutic (product) Indication

• Indication as "Disease/Symptom/Procedure"

• Co-morbidity

• Intended effect


3. Therapeutic (product) Indication – real examples


5.3.3 Reference strength

NOTE: This section is currently under discussion and further clarity will be introduced as part of

EU IG v2.

Field Value

SmPC text Each tablet contains 12 mg loperamide hydrochloride

corresponding to 10 mg loperamide

Active substance loperamide hydrochloride

Active substance strength presentation single value

or low limit numerator

12 mg

Active substance strength presentation single value

or low limit denominator

1 tablet

Reference substance Loperamide

Reference substance strength presentation single

value or low limit numerator

10 mg

Reference substance strength presentation single

value or low limit denominator

1 tablet


6.1 Packaged medicinal product

Packaged Medicinal Product

PCID EU-45678-99999-001

Package Description INFLUENZAVAC suspension and emulsion for emulsion for injection, pandemic influenza vaccine (H1N1) (split virion,

inactivated, adjuvated), pack of one vial (type I glass) of 2.5 ml suspension with a stopper (butyl rubber) and one vial (type I

glass) of 2.5ml emulsion with a stopper (butyl rubber)

Package Item Container (1) Box

Package Item Container Quantity 1

Package Item Material Recycled Cardboard

Packaged Item Reference Reference to Package item 2 and Package

item 3

Manufacturing item Reference Not Applicable

Data Carrier Identifier (s) 02890138016090

Package Item Container (2) Vial


Package Item Material Type I glass

Package Item Component Type Stopper

Package Item Component Material Butyl Rubber

Manufactured Item (Manufactured

Dose Form)

Suspension for emulsion for injection

Packaged Item Reference Not applicable

Manufacturing item Reference Reference to Suspension for Emulsion for Injection

Package Item Container (3) Vial


Package Item Material Type I glass

Package Item Component Type Stopper

Package Item Component Material Butyl Rubber

Manufactured Item (Manufactured Dose Form) Emulsion for emulsion for injection

Packaged Item Reference Not applicable

Manufacturing item Reference Reference to Emulsion for Emulsion for

Injection

6.4 Marketing status

6.4. Marketing status

6.4.1. Country

6.4.2. Marketing Status

6.4.3. (Marketing Status) date Start date

6.4.4. (Marketing Status) date Stop date

This section provides information on the marketing status of the packaged medicinal product.Marketing status considers the concepts of placing in the market and market cessation. The terms“actual marketing” and “placing on the market” should be defined as when the medicinal product is“released into the distribution chain” e.g. out of control the Marketing authorisation holder. The“cessation of placing on the market” shall be defined, by analogy to the placing on the market, asthe “cessation of release into the distribution chain” with the consequence that the concernedproduct may no longer be available for the supply to the patients.

How to trace information about stop date?

Removal from market + end of shelf-life?


6.6 Packaged item (Container)

6.6. Packaged item (container)

6.6.1. Package item (container) type

6.6.2. Package item reference(s)

6.6.3. Manufactured item reference(s)

6.6.4. Device reference(s)

6.6.5. Package item (container) quantity

6.6.6. Data carrier identifier

6.6.7. Material

6.7. Package (component)

6.7.1. Component type

6.7.2. Component material

6.8. Device

6.8.1. Device type

6.8.2. Device identifier

6.8.3. Device trade name


6.9 Manufactured item

• The pharmaceutical form of the product as it is authorised and, where applicable, before transformation into the

administrable pharmaceutical form must be described in this section. There after referred to as the manufactured

item, as contained in the packaged medicinal product.

• A Medicinal Product may contain, in the packaging, one or more manufactured items and one or more

pharmaceutical products.

Examples of single manufactured item and single pharmaceutical product:

• “Film-coated tablet” involves a single manufactured item. This manufactured item corresponds with the

administrable dose form and pharmaceutical product (no previous preparation/combination with other

manufactured item is needed).

• Solution for Injection involves a single manufactured item. This manufactured item corresponds with the

administrable dose form and pharmaceutical product (previous preparation/combination with other manufactured

item is needed to prepare the administrable dose form, however the medicinal product does not include the

solvent).

Examples of multiple manufactured items and single pharmaceutical products:

• Powder for solution for injection and Solvent for Solution for injection in combined pharmaceutical form Powder

and Solvent for Solution for injection. This involves two manufactured items that should be combined to prepare

the administrable dose form and pharmaceutical product.

Examples of multiple manufactured items and multiple pharmaceutical products:

• “Oral Capsule” & “External Cream” correspond with two different administrable dose forms which does not need

combining for administration to the patient.

+ =

&


6.10 Shelf-life / Storage conditions

• The description of the shelf life and storage information of the medicinal product, as approved in the

terms of the marketing authorisation, should be specified. The shelf life and storage

conditions/scenarios should be listed in the Product information and section 2.2.3 of the electronic

application form (eAF). This includes shelf life and storage conditions as packaged for sale, shelf

life/storage conditions after dilution or reconstitution or any other scenario.

• This entity is repeatable to allow the introduction of different shelf-life/storage conditions in the same

product (e.g. shelf life and storage conditions for medicinal products as packaged for sale and after

dilution or reconstitution).

6.10. Shelf Life / Storage





Conclusions

1. Make sure you can access SPOR data

2. Make sure your SPOR data is available

• Organisations for manufacturers to be migrated end Q1/2020

3. Make a plan on how to use/consume SPOR data inside your organisation

4. Assess availability of data elements internally

• Review and establish/modify processes

• Train people on requirements and/or new/amended processes

• Source of information (documents, databases) and comparison between sources

needed?

• Review tools and technology

• Perform an assessment for data collection (how much time, resources) and

evaluate if technology can assist


Questions?

Questions

Timelines:

• Does the release of the IGs, give any indication of when the PMS enforcement has due date?

• By when is compliance mandatory?

• Are there final stablished timelines for the submission of data to IDMP? May it be delayed?

Other:

• Will there be enough alignment for global companies/internal systems to manage the data

consistently?

• How is the work being carried out in ISO IDMP influencing other governing bodies?

• Is the published documentation definitive or we can expect changes for some fields?


Thank you for your attention

If you have further questions or need our help in implementing IDMP, please feel

free to contact me: [email protected]

More webinars and interactive workshops will follow.

Stay tuned!

mailto:[email protected]

EU IG Version 1 Comparison between xEVMPD and IDMP ... · EU IG v2 will contain the operating model...

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