Transparent communication - AFMPS · 2020. 12. 16. · Annual Report 2014 Contents ... (IMP). After...

Transparent communication

ANNUAL REPORT 2014

are our concern!

Your medicinesand health products

| Annual Report 201402

Contents

Note from the Chief Executive Officer .............................................................03Mission, role and values ..................................................................................04Organisation chart of the famhp .....................................................................05

2014 Results for each of the five entities DIRECTORATE-GENERAL PRE AUTHORISATION ................................................. 08R&D Division (human) ..........................................................................................09Marketing Authorisation Division (human) .........................................................12Medicines for Veterinary Use Division .................................................................16Assessors Division .................................................................................................19Scientific-Technical Advice & Knowledge Management Unit .............................22Homeopathic & Herbal Medicines Unit ................................................................26Pharmacopeia/API Unit .......................................................................................32

DIRECTORATE-GENERAL POST AUTHORISATION ............................................... 34Marketing Authorisation Division (Variations & Renewals) ...............................35Vigilance Division (pharmaco, materio, haemo, bio) .........................................37Health Products Division .......................................................................................39Proper Use Division ...............................................................................................41

DIRECTORATE-GENERAL INSPECTION ............................................................... 42Industry Division ...................................................................................................43Distribution Division ..............................................................................................44Dispensing Division ...............................................................................................45Authorisations Division .........................................................................................46

Special Investigation Unit .....................................................................................47

SUPPORT SERVICES .......................................................................................... 52

B&MC Division .......................................................................................................53

ICT Division ............................................................................................................54

Translation Unit......................................................................................................57

CHIEF EXECUTIVE OFFICER’S SERVICES .............................................................. 58

Management support and PMO Co-ordination ...................................................59

Communication Division .......................................................................................60

Quality Division ....................................................................................................63

P&O Division ..........................................................................................................69

Legal Affairs Division ............................................................................................71

International Relations Unit ..................................................................................72

Human Tissue Material Co-ordination .................................................................. 74

A NUMBER OF BUDGETARY ELEMENTS ............................................................. 77

PERSONNEL INFORMATION ............................................................................. 81

THE THREE COMMITTEES OF THE FAMHP ......................................................... 85

THE SPEARHEADS OF THE FAMHP .................................................................... 87

INTERNATIONAL REPRESENTATIONS IN 2014 .................................................. 91

NATIONAL REPRESENTATION ........................................................................... 96

LEGAL CONTEXT OF THE FAMHP ....................................................................... 98

CONTACT ....................................................................................................... 101

COLOPHON .................................................................................................... 102

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NOTE FROM THE CHIEF EXECUTIVE OFFICER

DEAR READER,

This year, we are presenting our annual report in a new guise. We have incorporated the topics that we would particularly like to highlight into a newspaper. We hope that this format will effectively convey that our agency is involved with matters that are of importance for you, too, every single day.

In the second part, we provide our yearly overview of the operations and results of the different divisions, entities, units and co-ordinations of the famhp. Charts and data tables offer a clear illustration of our activities and the results achieved.

We consider 2014 to be the year marking the next phase in the life-cycle of our agency. For myself per-sonally, it was the beginning of my second mandate as Chief Executive Officer and for this period, a new, multi-year management plan has been created: the 2014-2018 Management Plan, which will allow us to further advance the professionalisation of the famhp.

I would like to summarise our ambition for the period 2014-2018 as follows: starting from our strategic goals, to consolidate our results and achievements and to provide our partners with the necessary support in order to face new challenges. I would especially like to emphasise two aspects here: meeting public health needs in relation to the fields of medicines and health products and reaffirming the central position of the patient.

We are going to have to confront numerous challenges, both external and internal: from increasingly critical patients with ever higher expectations, to the ageing population, Unmet Medical Needs, more “Europe” in the world, developments in the many fields falling under the famhp’s authority, new advanced therapies and personalised medicine, to the internal policy on personnel, ICT, budget, quality and management.

I would like to conclude with my sincere thanks to all of the agency staff for their hard work. I’m pleased to be able to rely on your expertise and commitment. I would also like to thank our partners, patients, health-care practitioners, the academic world, industry, the competent authorities and the political leaders of the member states and the European institutions for the constructive contribution they have made to the pro-fessionalisation of our agency.

Xavier De CuyperChief Executive Officer


MISSION

The famhp plays an essential role in the protection of public health with the following mission:

“Ensuring, from development to use, the quality, safety and efficacy: • of medicines for human and veterinary use, includ-

ing homeopathic medicines and herbal medi cines, pharmacy made and officinal preparations;

• of health products, including medical devices and accessories, and raw materials for the preparation and production of medicines.

Ensuring, from collection to use, the quality, safety and efficacy: • of all operations involving blood, cells and tissues,

which are also defined as health products”.*

ROLE

To ensure the quality, safety and efficacy of medicines and health products in clinical development and on the market.

VALUES

The values nurtured within the famhp are carefully selected and form the unifying theme in our day-to-day activities: • Integrity • Commitment • Adaptability • Team Spirit

* Based on the law of 20 July 2006 (BS-MB 08.09.2006)

concerning the establishment and functioning of the famhp.

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MISSION, ROLE AND VALUES

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Your medicines and health products


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2011

ORGANISATION CHART OF THE FAMHP

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Consultative Committee

Executive Council

Health Products Division

Vigilance Division(pharmaco, materio,

haemo, bio)

Proper Use Division

Marketing Authorisation

Division(Variations & Renewals)

Medicines for Veterinary Use

Division


Division (human)

Assessors Division

R&D Division(human)

DG PREauthorisation

DGINSPECTION

Translation Unit

P&ODivision

ICT Division

B&Mc Division

Support services

DG POSTauthorisation

Co-ordinators Spearheads

Crisis Entity(non permanen)

Transparency Committee

Scientific Committee

Chief Executive Officer

Legal Affairs Division

Quality Division

Communication Division

Chief ExecutiveOfficer’s Services

Human Tissue Material

Co-ordination

International Relations Unit

Management Support

Co-ordinationPMO

Dispensing Division

DistributionDivision

Authorisations Division

Industry Division

SOE-USE / Special Investigation Unit

07

2014 RESULTS for each of the five entities


DIRECTORATE- GENERAL PRE AUTHORISATIONcompetent for all activities prior to approval of the first marketing authorisation for a medicine or health product

Administrative support

CHMP member

Management support

Director-general of the DG PRE authorisation

Homeopathic & Herbal

Medicines Unit

Scientific- Technical Advice & Knowledge Man-

agement Unit

Pharmacopeia/API Unit

Team I Team II Team III

Team Biologicals

& ATMP

Responsible BE/PK

Assessors Division

Preclinical & Clinical

Veterinary Entity

Non-Clinical Entity

Clinical Human Entity

Quality Entity

R&D Division(human)


Ethics committee

CollaborationEntity

Clinical Trials Entity

Follow-up Entity

CU-MNP Entity


Division (human)

CP Entity

MRP/DCP/NP Entity

File Management Co-ordination


Co-ordination

Closing Entity

Staff assistant

Vaccines & Antiparasitic Medicines

Entity

Pharmaceuticals Entity


Division

Team Chemicals

Team Herbals & Antibiotics


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KEY TASKS

The most important basic task of the R&D Division (human) is handling files related to authorisations for clinical trials, Clinical Trial Applications (CTA) and amendments to such files. The files are submitted by the sponsors of clinical trials: commercial or academic sponsors. After validation, the files are verified and if necessary passed to the Assessors Division to evaluate the results of the quality aspects and/or non-clinical data for the Investigational Medicinal Product (IMP). After this process has come to an end, the agency’s decision is communicated to the company/sponsors and the file is closed and archived.

The R&D Division (human) also participates in the European Voluntary Harmonisation Procedure (VHP). This is a procedure in which a harmonised evaluation of multinational clinical trials takes place in collabora-tion with the various authorities involved. Belgium is quite heavily involved in this procedure, both in its role as Reference Member State (RMS) and as Concerned Member State (CMS).

Since December 2012 there have been new modes of application for submitting an Annual Safety Report (ASR) in the form of a Development Safety Update Report (DSUR). The R&D Division (human) follows these reports closely, in order to protect participants of clinical trials.

Another important task is the handling of questions concerning clinical trials or research and development.

The division handles application files for medicines without MA for Compassionate Use (CU) or for medi-cines in Medical Need Programs (MNPs).

The division also participates in discussions around the following important projects:• the issue of faster access to innovation for Unmet Medical Need (UMN) with reimbursement for mol-ecules for which the authorisation procedure is pending, based on the therapeutic importance and the po-tential to access reimbursement outside of indication;

• the amendments to the law of 7 May 2004 on human experiments as well as the revision of the European Directive 2001/20.

R&D Division(human)


Ethics committee

CollaborationEntity

Clinical Trials Entity

Follow-up Entity

CU-MNP Entity

R&D DIVISION (human)

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| Annual Report 2014| Annual Report 201410

Month in 2014 1 2 3 4 5 6 7 8 9 10 11 12 Total2014Total 2013

Total 2012

Total 2011

Applications and substantial amendments

Applications (original) 49 52 44 59 40 33 42 35 61 51 40 62 568 554 496 534

Substantial amendments submitted

116 138 120 152 130 182 185 161 155 162 96 152 1,749 1,776 1,596 1,522

Applications (original + substantial amendments) closed within the statutory timeframes

87.43% 91.63% 87.11% 97.26% 93.65% 91.25% 94.00% 91.78% 88.24% 86.92% 88.59% 91.81% 90.90% 98.2% 88.8% 96%

Questions regarding clinical trials or research and development

Answers to known questions within two days

95% 100% 89% 100% 100% 100% 100% 100% 100% 100% 95% 94% 98% 94% 97.9% 100%

Answers to new questions within five days

49% 77% 72% 89% 76% 85% 80% 57% 63% 76% 56% 52% 69% 64% 79.9% 76%

ASR in the form of a DSUR

Reports received 730 712 / /

SOME FIGURES FOR 2014

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YEAR 2011 2012 2013 2014

Voluntary Harmonisation Procedure (VHP)

Total number of applications 82 117 143 173

Belgium as CMS 38 63 78 59

Belgium as RMS 1 9 5 4

Medicines without MA in CU and medicines in MNPs

General CUs 11 7 4 12

Amended CUs 4 4 5 5

Exceptional CUs 3 7 6 3

General MNPs 20 19 34 22

Amended MNPs 9 20 12 27

Exceptional MNPs 0 10 6 17

General CUs (new regulations) n/a n/a n/a 1

Amended CUs (new regulations) n/a n/a n/a 0

General MNPs (new regulations) n/a n/a n/a 1

Exceptional MNPs (new regulations) n/a n/a n/a 0


KEY TASKS

The main responsibility of the Marketing Authorisation Division (human) consists of following up MA appli-cations of medicinal products for human use. This fol-low-up involves three phases - validation, manage-ment and evaluation - in order to reach a final decision and possibly grant a MA.

The main tasks of the Marketing Authorisation Division (human) are: • receipt and validation of MA applications; • receipt and administrative monitoring of Active

Substance Master Files (ASMF); • co-ordination and follow-up of applications in func-

tion of the deadlines; • ensuring the link between the pharmaceutical

industry, national and international bodies such as the EMA, internal and external assessors and partner institutions such as the Wetenschappelijk Instituut voor de Volksgezondheid (Scientific Institute for the Public Health, WIV-ISP);

• ensuring the secretariat of the Evaluation commis-sion for medicines for human use;

• active participation in consultations with other competent authorities, such as the Co-ordination Group for Mutual Recognition and Decentralised Procedures (CMDh) and the Belgian Regulatory Affairs Society (BRAS) regarding regulatory affairs;

• drafting of Public Assessment Reports (PARs); • administrative closing of files and delivery of MAs.

MARKETING AUTHORISATION DIVISION (human)


Division (human)

CP Entity

MRP/DCP/NP Entity

File Management Co-ordination


Co-ordination

Closing Entity

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National procedure for obtaining a MA (NP) 26 applications were closed for NP in 2014.

Number of submitted applications (IN) and number of applications closed (OUT)

Applications Total in 2011 Total in 2012 Total in 2013 Total in 2014

IN 270 262 221 240

OUT (without variations) 467 274 222 225

Total OUT 538 330 256 287

Notes: • The division recorded a small increase in the number of new applications in

2014. • The total number of applications closed (total OUT) relates to the number of

applications closed without variations (OUT without variations) increased with the number of variations that were closed by the division just after the final approval and which therefore had not yet been granted a MA.

.



IN 44 23 23 18

OUT 32 23 26 25

Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) for obtaining a MA225 applications were closed for the MRP and DCP.



IN 376 449 418 395

OUT 370 384 377 358

Centralised Procedure for obtaining a MA (CP)


Number of submitted files (IN) by type

Type of procedure IN Total in 2011 Total in 2012 Total in 2013 Total in 2014

Full application 10 12 5 12

Line extension 0 1 0 0

Renewal 5 5 3 8

Variation IA 46 44 54 33

Variation IB 31 75 75 94

Notification 21 2 0 3

Grouped variation 8 11 12 19

Grouped variation IA 42 51 50 38

Grouped variation IB 22 25 30 37

Analytical variation (60 days) 24 22 20 30


Clinical variation (60 days) 22 32 47 49


Post Approval Commitment (PAC) 137 165 120 70

Referral 4 4 0 1

Total 376 449 418 395

Note:Due to a change in representation within the Committee for Medicinal Products for Human Use (CHMP) and the limited capacity of preclinical and non-clinical assessors, for a number of months in 2013 the division was unable to act as rapporteur/co-rapporteur/peer reviewer. This led to fewer full applications in 2013 than in 2012. In 2014 the new CHMP team was fully operational and capacity was expanded among the assessors, which enabled us to resume active application for new rapporteurships. For this reason, with 12 new full applications in 2014, we were able to return to the level of previous years.

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Number of applications closed (OUT) by type

Type procedure OUT Total in 2011 Total in 2012 Total in 2013 Total in 2014

Full application 3 11 9 9

Line extension 4 0 1 0

Renewal 11 8 0 9

Variation IA 42 40 51 33

Variation IB 30 78 58 95

Notification 16 2 0 4

Grouped variation 9 10 11 16

Grouped variation IA 43 51 53 40

Grouped variation IB 22 23 30 39





Post Approval Commitment (PAC) 116 117 99 48

Referral 1 5 0 1

Total 370 384 377 358


KEY TASKS

The main task of the Medicines for Veterinary Use Division is, according to the NP, MRP or DCP, the vali-dation, management and closing of files for: • applications for MA; • analytical and clinical variations; • five-yearly renewals (RQs).

The division also provides administrative support to the Belgian delegates in the Committee for Medicinal Products for Veterinary Use (CVMP). This committee evaluates applications for new veterinary medicines via the CP in Europe.

Furthermore, the division is responsible for authorising clinical trials for medicines intended for veterinary use, medical devices for veterinary use, parallel import, management of the infovet mailbox and participation in working groups at European and national level.

In addition, the division ensures the transversality of veterinary issues within the agency. There is close col-laboration with the CVMP by means of administrative and logistics support in realising its tasks.

In 2014 the division actively participated in organising the veterinary TOPRA symposium (The Organisation for Professionals in Regulatory Affairs), which was held in Brussels.

The division is also actively involved in consultation at the European level concerning the revision of the European regulation for veterinary medicines and ana-lyses were also begun for the development of a data collection system for gathering sales data on antimi-crobial products in the veterinary sector.

MEDICINES FOR VETERINARY USE DIVISION

Staff assistant

Vaccines & Antiparasitic Medicines

Entity

Pharmaceuticals Entity


Division

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Number of applications submitted and closed for medicines for veterinary use

ProcedureIN 2013

(calculation according to the old system)

OUT 2013 IN 2013 (MeSeA)IN 2014 (MeSeA)

OUT 2014 (MeSeA)

OUT 2014 (DataPerfect)

NP

Variations IA & IB 763 165 229 187 179 25

Variations II 64 3 43 35 31 23

Renewals 11 1 10 20 5 27

MA applications 33 13 31 15 11 3

Clinical trials 12 11 10 15 16 0

MRP

Variations IA & IB 905 216 391 372 279 13

Variations II 135 15 69 54 31 14

Renewals 75 4 55 59 5 4


DCP


Total 2,151 441 951 820 609 123


Evolution of the number of open files for medicines for veterinary use in the previous database

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Notes:• The total number of files received declined slightly in 2014. This slowdown is in

line with the decrease also seen in the files for medicines for human use.• As a result of the introduction of the application for electronically archiving and

tracking metadata such as information on the composition, manufacturers and pa-tient information leaflets on a medicine (MesExtra UI) and the associated workload for expanding the data models and quality control in closing the files, there was a slight decline in the number of files closed for 2014.

• In 2014 Belgium was the rapporteur for three new applications for obtaining a MA via CP, and was rapporteur or co-rapporteur for 25 variations and 3 renewals.

• In 2014 Belgium is acted as the RMS for one new applications for obtaining a MA via MRP, for 12 variations and 1 repeat use procedure (= procedure whereby, after an initial MRP in a number of member states, there is a second round in which the procedure is repeated in a number of member states that were not initially involved).

NP

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KEY TASKS

The Assessors Division assesses scientific data for in-stances including applications for scientific advice, clini-cal trials and MAs submitted by external stakeholders.

In order to assess scientific data in a professional and efficient manner, there is ongoing maintenance and strengthening of expertise within the division. Various systems have also been developed in order to check and guarantee the quality of the work. Assessors represent the famhp in most international scientific committees and working groups.

All of these aspects contribute to an increase in the national and international recognition of the famhp.

ORGANISATION

The division consists of: • the Preclinical & Clinical Veterinary Entity or the

groups of assessors who deal with the (pre) clini-cal aspects of veterinary medicines and in which each assessor follows up a number of specific therapeutic areas;

• the Non-Clinical (human) Entity in which the var-ious assessors have their own areas of expertise such as vaccines, Advanced Therapy Medicinal Products (ATMPs), biosimilar medicines, nanomedi-cines, early phase clinical trials and paediatrics;

• the Quality Entity or the group of assessors who deal with the quality of medicines (human and veterinary use) with specialists in chemical pro-ducts, biological products, plant based medicines and ATMP medicines;

• the Clinical Human Entity or the group of asses-sors in which some employees concentrate on bio-equivalence (BE) and pharmacokinetics (PK), biostatistics or the methodology of clinical trials, while others follow one or more pharmacothera-peutic areas.

In 2014 the first steps were also taken in the develop-ment of a unit of assessors for medical devices, MedDev.

ASSESSORS DIVISION

Assessors Division

Preclinical & Clinical

Veterinary Entity

Non-Clinical Entity

Clinical Human Entity

Quality Entity



The tables below give an overview of the number of assessment reports closed in 2014, by type of procedure for medicines for human and veterinary use.

Number of assessment reports for medicines for human use

Quality Non-clinical Clinical bio-equivalence and pharmacokinetics Total Total Total Total

First round

From second round

First round

From second round

First round

From second round

First round

From second round

2011 2012 2013 2014

MA

NP new 53 57 40 16 40 40 2 6 197 221 224 254

NP variation and renewal 147 144 242 202 274 196 8 8 919 822 1,057 1,221

MRP & DCP 74 69 34 18 286 232 54 14 808 1,013 1,002 781

CP 53 26 74 52 102 60 14 20 351 371 408 400

Scientific technical advice

51 50 110 42 221 210 240 253

Clinical trial

218 30 164 68 38 64 0 0 770 643 742 582

Total 594 326 604 356 850 592 120 48 3,407 3,139 3,673 3,490

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Number of assessment reports for medicines for veterinary use

Quality (pre-)Clinical Total Total Total Total

First round From second round First roundFrom second

round 2011 2012 2013 2014

MA

NP new 5 5 4 4 24 22 10 17

NP variation and renewal 59 38 6 24 265 189 139 126

MRP & DCP 3 14 60 46 95 45 72 123

CP 5 9 8 18 29 23 39 40

Scientific advice

0 6 1 3 0 6

Clinical trial

0 0 0 0 20 4 1 0

Total 71 65 84 92 434 286 261 311


KEY TASKS

The most important responsibility of the Scientific-Technical Advice & Knowledge Management Unit (STA-KM) consists of ensuring a centralised, effective and transparent service that guarantees the handling of national STA applications within the statutory time-frame. For each STA application, and in close collabora-tion with the Assessors Division, the most suitable in-ternal and/or external experts are involved in providing direct and high quality advice. In doing so, there must be a guarantee of absolute confidentiality and any po-tential conflict of interest (COI) for those involved must be avoided. The famhp follows an analogue method for COI management as it does at EMA level.

For STA applications that require multidisciplinary advice, the STA-KM Unit works closely with divisions within the famhp, with other national public services and institutions such as WIV-ISP, the Federal Agency for Nuclear Control (FANC) and the National Institute of Health and Disability Insurance (RIZIV-INAMI), as well as with other national and international author-ities for joint STA applications such as the Medicines Evaluation Board (CBG-MEB), the EMA and the World Health Organization (WHO).

In the context of Unmet Medical Needs (UMN) the STA-KM Unit collaborates closely with the experts from the RIZIV-INAMI on the further development of

the procedure for processing joint STA-HTA (Health Technology Assessment) requests at the national level.

The most important tasks of the STA-KM Unit are:

• Validation, management, comprehensive coordi-nation and closing of applications for national STA;

• handling general as well as specific file rela-ted questions (FAQs) about national STA ser-vices which are received by telephone, post or e-mail through the unit’s general e-mail address: [email protected];

• consistent follow-up of previously granted national and European advice reports via channels including the Belgian representatives of the Scientific Advice Working Parties (SAWP and SAWP-Veterinary), the Committee for Advanced Therapies (CAT), the Committee for Medicinal Products for Human Use (CHMP), and the Paediatric Committee (PDCO) of the EMA;

• administrative management of European advice requests co-ordinated by Belgian SAWP members;

• management of the STA-SAWP database at the famhp;

• co-ordination of portfolio meeting requests, high-level informative meetings between the parties requesting advice and experts and division heads of the famhp;

SCIENTIFIC-TECHNICAL ADVICE & KNOWLEDGE MANAGEMENT UNIT

Scientific- Technical Advice & Knowledge Man-

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• management of the internal and external expertise network at national and European level including the management of the expert database and the Knowledge Management (KM) project;

• improvements to an expansion of new strategic partnerships and interaction mechanisms with external experts in line with the further expan-sion, consolidation and distribution of external expertise;

• co-ordination of and participation in various pro-jects within the famhp that are important for building up expertise and the further expansion of national STA services such as the UMN projects and national Medical Devices Plan (PMH-PDM) and the revisited GMC;

• active participation in the working group for deve-loping the EARLY PHASE DEVELOPMENT spearhead.

MOST IMPORTANT REALISATIONS IN 2014

• implementation of a procedure for portfolio meet-ings (see the Famhp Times paper);

• communication about the STA services, to small and medium-sized enterprises (SMEs) in the SME newsletter of pharma.be, the general association of the pharmaceutical industry in Belgium;

• review of the famhp/WIV- guideline on Clinical

Trial Applications (CTAs) with Genetically Modified Organisms (GMOs) and the prior national STA;

• optimisation of the STA procedures and of the operational working of the unit and the procedure for handling SAWP advice based on an internal audit of the STA-KM Unit;

• internal training on the procedures for national STA and SAWP;

• an updated version of the STA-SAWP database for optimal use within the famhp;

• an updated version of the expert database in-cluding adding the expertise on medical devices within the famhp;

• participation in the structuring of a needs analysis and draft regulations for UMN;

• implementation of a document management sys-tem (DMS) at famhp level; development of the mission and vision of the DMS system, the basic structure of the Sharepoint DMS-system, the basic document governance rules and the delivery of identified quick wins.


Table 1 2013IN2013OUT

2014IN

2014OUT

Total number of national STA applications 34 38 33 35

According to procedure TYPE III STA29 30

20 20

TYPE II STA 11 12

TYPE I STA 5 8 2 3

According to spearheads VACCINES 12 12 9 10

EARLY PHASE DEVELOPMENT 10 13 14 13

ONCOLOGY 2 2 7 8

According to use Human use 34 36 33 35

Veterinary use 0 1* 0 0

* One STA application was not related to medicines for human or veterinary use.

FIGURES FOR 2014

Tables 1 and 2 respectively provide an overview of the number of national and European advice reports that were processed in 2014 as compared to 2013. Table 3 shows the number of questions (FAQs) hand-led by the STA-KM Unit concerning national STA and the timeframe within which these questions were answered.

Table 4 gives an overview of the number of portfolio meetings that were organised by the STA-KM Unit at the request of pharmaceutical companies (2014 com-pared to 2013), either concerning multiple therapeutic areas or on specific areas falling within the scope of the famhp spearheads.

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Table 2 2013IN2013OUT

2014IN

2014OUT

Total number of European SAWP/SAWP-V applications 90 90 86 86

According to procedure Scientific Advice 87 87 81 81

Qualification procedures and HTA 2 2 4 4

According to spearheads VACCINES 6 4 4 6

EARLY PHASE DEVELOPMENT 4 3 1 2

ONCOLOGY 11 12 24 25

According to use Human use (SAWP) 89 89 85 85

Veterinary use (SAWP-V) 1 1 1 1

Table 3: number of FAQs processed

Month in 2014 1 2 3 4 5 6 7 8 9 10 11 12 Total in 2014

Questions received 15 10 16 12 12 4 9 8 10 14 10 5 125

Answered within 5 days 13% 30% 6% 8% 8% 0% 0% 0% 10% 0% 0% 20% 8%

Table 4: number of portfolio meetings held

2013 2014

General portfolio meetings 1 2

Vaccine portfolio meetings 1 2

Oncology portfolio meetings 1 2

In 2014, the Homeopathic & Herbal Medicines Unit focused on documenting our service and monitoring the activities carried out by this unit. This data should offer better insight into the various activities, the time spent on them and the related costs. Analysis of this data will form the basis for further optimisation of the core processes and increased cost-effectiveness.

HOMEOPATHY

The ultimate goal is the prompt processing of the MA applications for homeopathic medicines. In order to achieve this goal, in 2014 the following two projects for improvement were completed: • In collaboration with the industry stakeholders,

the database for notified homeopathic medicines was updated. The new list of notified homeopathic medicines was reduced from 18,000 in 2003 to the current number of 5,654.

• In terms of file management, there were various consultation opportunities in the course of the year between the sector and the administration. The purpose of these bilateral meetings is to re-inforce the interaction between the sector and the administration and to set priorities for the file management. Systematic consultation was also organised with the stakeholders in order

to define the working points for the year 2015 and reflection was begun on the availability of homeopathic raw materials and on adverti-sing files for notified homeopathic medicines. In addition, together with the sector there was consideration of how the patient information leaf-lets for homeopathic medicines should be modi-fied in order promote better use of these products.

Finally, at the end of 2014, a version of the e-Sub-mission and e-Approval system (MeSeA) was rolled out in a form specially adapted to the needs of file management for homeopathic medicines which should enable these files to be processed more efficiently in the future.

HERBAL MEDICINES

In 2014 the unit continued to work on more efficient processing of files for herbal medicines, taking into consideration the fact that the majority of the appli-cations are submitted via the national procedure for obtaining a MA (NP).The unit also played an active role in the European reg-istration procedures for herbal medicines which were launched with Belgium as reference member state.The unit played a leading role in the start-up and

HOMEOPATHIC & HERBAL MEDICINES UNIT

| Jaarverslag 201426

Homeopathic & Herbal

Medicines Unit

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activities of the Working Group on the Use of Medicinal Cannabis. This working group was given a mandate by both the Commission for Medicines for Human Use and the Committee on Herbal Medicinal Products to update the existing advice from the Commission for Medicines for Human Use dating from 17 March 2006 on medicinal cannabis in light of current scientific in-sights. The proposal for advice was based on scientific assessment reports drawn from the available data on the quality of the raw materials, about the use of medicinal cannabis and about the safety of cannabis (products). This draft advise report to the Minister was ratified by both commissions. Based on the advice, the Minister may decide whether or not to amend the existing regulations and whether new measures may need to be taken.

KEY TASKS

The role of the Homeopathic & Herbal Medicines Unit is to grant and follow-up registrations and MAs for homeopathic medicines and herbal medicines. This unit is therefore charged with evaluating and managing, in the broadest sense of the word, application files for registration and MA for homeopathic medicines and herbal medicines, as well as with treating applications for variations to existing registrations and MAs.The unit works with internal and external experts to guarantee the quality, safety and efficacy of this cate gory of medicines, in consideration of the specific regulations.

The unit also plays a role in the granting of STA.

The Homeopathic & Herbal Medicines Unit coordinates the tasks and ensures the secretariat of two indepen-dent committees: • the Evaluation commission for homeopathic me-

dicinal products for human and veterinary use (HCG-HCM);

• the Evaluation commission for traditional herbal medicines for human use (CKG-CMP).

Employees of the unit represent the famhp at European level in committees and working groups such as the Committee on Herbal Medicinal Products (HMPC), the Homeopathic Medicinal Products Working Group

(HMPWG ) and the European Directorate for the Quality of Medicines & HealthCare (EDQM).


BALANCE 2014 - HOMEOPATHIC MEDICINES

The file management for homeopathic medicines was optimised and processes were refined. This resulted in more efficient processing of the files, allowing the successful completion of 52 files related to homeo-pathic medicines.

The following evolution was seen in the results:

NP = national procedure

0

10

20

30

40

50

60

201420132012201120102009

42 1

3

8

52

Number of files closed for homeopathic medicines per year 0

5

10

15

20

PSUR(Periodic SafetyUpdate Report)

Notification -change indatabase

Variation -Type IB NP

Variation -Type IA NP

New Registration(new & line

extension) NP

New authorisation(full &

abridged & lineextension) NP

NP referencedossier

NP gentlemen'sagreement

Broken down per file type

2012 2013 2014

Homeopathic medicines for human use

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0

10

20

30

40

50

60

70

80

20142013201220112010200920082007

Initial assessment module 3

Assessment answers module 3





The evolution in the evaluation of files reflects the processing of the backlog and the start of the evaluation of newly submitted files. Giving priority in the evaluations to long-standing files is in line with the results of the ana-lysis carried out in the context of the improvement project intended to ultimately result in a phased prioritisation.


BALANCE 2014 – HERBAL MEDICINES

2012 saw an exceptional 144 files closed for herbal medicines thanks to the implementation of a new follow-up system and an increase in staff. This led to a large number of files being closed that had been waiting for closing for some time.As in previous years, in 2014, the new approach in file management proved its worth: 94 files for herbal medicines were successfully closed.

CMS = Concerned Member StateDCP = Decentralised Procedure obtaining a MAMRP = Mutual Recognition Procedure for obtaining a MA NP = national procedureRMS = Reference Member State

0

30

60

90

120

150

201420132012201120102009

5965

57

144

10494

Number of files closed for herbal medicines by year

0

10

20

30

40

50

60

70

NP reference

dossier

Pub NP gentlemen's agreement

PSURAdministrative variation

Variation Type II - Clinical

MRP CMS

Variation Type II -

Analytical MRP CMS

Variation - Type IB MRP CMS

Variation - Type IA MRP CMS

Renewal MRP CMS

Variation - Type IB

MRP RMS

Variation Type II -

Clinical NP

Variation Type II -

Analytical NP

Variation - Type IB NP

Variation - Type IA NP

Renewal NP

New Registration

(new & line

extension) DCP CMS

New Registration

(new & line

extension) DCP RMS

New Registration

(new & line

extension) MRP CMS

New Registration

(new & line

extension) NP

New authorisation

(full & abridged

& line extension) DCP CMS

New authorisation

(full & abridged

& line extension) MRP CMS

New authorisation

(full & abridged

& line extension)

NP

Broken down per file type:

Herbal medicines

2009 2010 2011 2012 2013 2014

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4

6

8

10

12

14

16

18

New Registration (new & line extension)

DCP CMS


DCP RMS


MRP CMS


NP

New authorisation (full & abridged&line extension) DCP CMS

New authorisation (full & abridged&line extension) MRP CMS

New authorisation (full & abridged&line

extension) NP

Herbal medicines - new MA - Registration

For the national variations, in detail:

0

10

20

30

40

50

60

70

Variation Type II Clinical NPVariation Type II Analytical NPVariation Type IB NPVariation Type IA NP

Herbal medicines - variations NP 2009 2010 2011 2012 2013 2014

2009 2010 2011 2012 2013 2014

For the applications for marketing authorisation or registration, in detail:

KEY TASKS

The main tasks of this unit are: • contributing to the improvement of the quality

of pharmacy made and officinal preparations; • processing applications for authorisations; • processing files within the activities of the

European Pharmacopoeia Committee.

PHARMACOPEIA/API UNIT


Pharmacopeia/API Unit

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Results achieved

Situation on 31 December 2011 2012 2013 2014

Total number of applications for authorisation to be processed 1,285 100.00% 760 100.00% 568 100.00% 1,203 100%

Total number of authorisations granted 663 51.60% 417 54.87% 92 16.20% 313 26.02%

Total number of licences revoked 622 48.40% 813 52.38% 14 2.46% 4 0.33%

Remaining number of authorisation applications pending on 31 December 622 48.40% 343 45.13% 462 81.34% 892 74.15%

of which: pending on company level 303 48.71% 269 78.43% 363 78.57% 881 73.23%

pending on administration level 115 18.49% 68 19.83% 97 21.00% 11 0.91%

pending on assessors level 2 0.32% 0 0.00% 0 0% 0 0%

ready to be granted 204 32.80% 3 1.46% 2 0.43% 0 0%


Director-general of the DG POST authorisation




Call Center Entity

Change MAH/ Batch Releaser

Entity

Parallel Import Entity

Management support

Variations without/with Minor

Impact on MA/ EC Decisions,

EU Recommends Entity

Cluster Entity


Medical Devices Entity

Proper Use Division

Information & Documentation

Entity


Database of Medicinal Products

Entity

Advertising Entity

RMP – Risk Management

Plan Entity


haemo, bio)


ADR Co-ordination

Human PhV/Evaluation Entity

Veterinary PhV Entity

Management support

Humane PhV/File management/

ADR Entity

File manager

Europa Co-ordination

Materiovigilance Entity

Bio- en Haemovigilance

Entity


DIRECTORATE-GENERAL POST AUTHORISATIONcompetent for all activities following approval of the first marketing authorisation for a medicine or health product


35

KEY TASKS

The main task of the Marketing Authorisation Division (Variations & Renewals) is dealing with applications for variations and renewals of MAs for medicinal products. The files pass through various phases: loading into the database, evaluation of the requested variations and administrative closing.

The division is divided into several entities, with the most important tasks being: • Variations without/with Minor Impact on MA/

EC Decisions, EU Recommends Entity (Marketing Authorisations – MAs, European Commission, European Union)

This entity deals with all variations IA/IB that have little or no impact on the MA, SPC and the patient information leaflet. The files are loaded into the database, evaluated by our staff and closed.

Given the pressing nature of these variations to the SPC and patient information leaflet in terms of safe use of the respective medicines, these files are handled by a separate entity that has to guarantee the information is included in the SPC and patient information leaflet as soon as possible.

• Change MAH/Batch Releaser Entity (Marketing Authorisation Holder)

This entity is responsible for the transfer of MAH and variations to batch releasers responsible for batches of medicines.

• Cluster Entity This entity deals with all other variations that may

have a significant impact on the MA, SPC, patient information leaflet and packaging or mock-up (=a flat design, in colour with the final font and final font size, that gives a clear view of the three- dimensional presentation of the packaging). As well as uploading the files to the database and evaluating and managing these files during the evaluation phase, these files are administratively closed by a customised MA, along with the ap-proved SPC and patient information leaflet, to be sent to the MAH.

The Marketing Authorisation Division (Variations & Renewals) is the responsible for handling applications for parallel import and applications for withdrawals of MAs, within the Parallel Import Unit.

The Call Center Entity for MA is also part of this division.

MARKETING AUTHORISATION DIVISION (Variations & Renewals)

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Call Center Entity

Change MAH/ Batch Releaser

Entity

Parallel Import Entity

Management support

Variations without/with Minor

Impact on MA/ EC Decisions,

EU Recommends Entity

Cluster Entity


Situation 2011 2012 2013 2014

Entity IN OUT IN OUT IN OUT IN OUT

Variations without/with Minor Impact on MA 4,055 4,110 4,599 4,302 4,698 5,347 4,039 4,061

EC Decisions, EU Recommends 174 123 259 169 334 169 599 416

Change MAH/Batch Releaser 400 633 385 621 297 384 268 305

Cluster 3,970 4,571 3,314 3,385 2,409 2,932 2,267 2,600

Notes: • 293 files were closed following the scrapping of MA, 72 files work revoked by the MA holder and 17 files were rejected. • Figures included in IN but not in the OUT figures for this division are included here: – 50 files were entered twice; – 76 files were dealt with by the Homeopathic & Herbal Medicines Unit; – 37 files were closed at the same time as the application for a new authorisation by the Marketing Authorisation Division (human).


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KEY TASKS

The Vigilance Division (pharmaco, materio, haemo, bio) monitors the safety in use of medicines for human and veterinary use (= pharmaco vigilance), of medical devices (= materiovigilance), of blood and unstable blood products of human origin (= haemovigilance) and of human tissue material (= biovigilance). This res-ponsibility includes gathering information, evaluating that information and, if necessary, taking corrective measures.

The main tasks of the division are: • collection and evaluation of: - individual reports of adverse reactions from MAH

and healthcare professionals (medicines for hu-man and veterinary use);

- Periodic Safety Update Reports (PSURs) - for medicines for human and veterinary use;

- Risk Management Plans (RMPs) - for medicines for human and veterinary use;

- incidents after using medical devices; - information about serious adverse events and

reactions with blood and blood components; - information about serious adverse reactions and

events with human tissue material (MLM-MCH); • participation in the evaluation of applications for

five-yearly renewals (RQ) (medicines for human and veterinary use);

• participation in activities relating to vigilance in the European context (medicines for human and veterinary use);

• dissemination of information about vigilance for the attention of healthcare professionals and the public;

• implementation of measures proposed following evaluation of pharmacovigilance data (medicines for human and veterinary use). This is done in collaboration with the Marketing Authorisation Division (Variations & Renewals) of the DG POST authorisation and with the DG PRE authorisation;

• implementation of measures proposed after eva-luation of data about materiovigilance, haemovi-gilance and biovigilance.

VIGILANCE DIVISION (pharmaco, materio, haemo, bio)


haemo, bio)


ADR Co-ordination

Human PhV/Evaluation Entity

Veterinary PhV Entity

Management support

Humane PhV/File management/

ADR Entity

File manager

Europa Co-ordination

Materiovigilance Entity

Bio- en Haemovigilance

Entity


Activity (number of applications submitted) 2011 2012 2013 2014 Evolution 2013-2014

Pharmacovigilance of medicines for human use

PSUR 1,700 1,705 1,154 796 - 31%

Individual reports of adverse reactions 4,601 5,279 5,259 5,387 + 2%

Pharmacovigilance for medicines for veterinary use

PSUR 744 670 840 901 + 7%

Individual reports of adverse reactions 314 442 272 389 + 43%

Materiovigilance

Number of reports 1,641 1,714 2,001 2,335 + 17%

Haemovigilance

Number of serious adverse events and reactions 943 917 989 853 - 14%

Biovigilance

Number of serious adverse events and reactions 33 9 47 130 + 177%

Backlog EudraVigilance (January 2005-April 2008): evolution of the % of reports yet to be processed

Electronic forms 0% 0% 0% 0% 0%

Yellow paper forms 34% 34% 34% 34% 34%


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KEY TASKS

In 2014 then Medical Devices Entity continued with the implementation of the Belgian Medical Devices Plan (PMH-PDM).

The entity followed European work in line with: • the development of European regulations about

variations to notified bodies; • the European recommendations about audits car-

ried out by notified bodies; • the consultation about the future European regu-

lations relating to medical devices.

The entity continued to actively contribute to the sys-tematic updating of the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices.

The Medical Devices Entity deals with applications for distribution notifications, applications for export certificates, notifications of clinical trials for medical devices without a CE mark, notifications for activities of manufacturers of custom medical devices, notification for trading of class one medical devices, applications for accreditation within the context of the care plan for diabetes and applications for exceptional use. On a daily basis, the entity responds to all sorts of questions and follows up processing of fees.

HEALTH PRODUCTS DIVISION





Activity 2011 2012 2013 2014

IN OUT IN OUT IN OUT IN OUT

Declaring taxes 829 829 897 897 2,160 2,160 1,027 1,027

Notifications for distribution 245 240 315 325 331 290 522 509

Export certificates 690 791 1,336 1,359 1,431 1,397 1,508 1,459

Clinical trials 36 22 26 21 46 39 30 (until 31 October)

35 (until 31 October)

Customised manufacturer notifications 45 45 35 35 13 13 28 28

Notifications class I manufacturers 200 582 189 364 203 156 332 358

Approval in the context of the care plan for diabetes 1 1 0 0 1 1 2 2

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KEY TASKS

The main tasks of the Proper Use Division are: • ensuring the application of the Sunset Clause and

therefore withdrawal of the respective MAs. If an authorised for registered medicine is not actually traded for a period of three consecutive years, then the MA or registration for that medicine will expire in accordance with the Law on medicines of 25 March 1964 (article 6, § 1ter);

• providing information about medicines and health products;

• in terms of medical advertising: setting stand-ards and, particularly in terms of public advertis-ing, carrying out prior controls on advertisers for medicines and information campaigns on radio or television that refer to medicines;

• assessing and approving Additional Risk Minimi-sation Activities (RMA) which are compulsory for some medicines in order to be granted a MA.

2011 2012 2013 2014

MA withdrawn in line with the Sunset Clause

919(April 2010-2011)

217 188 174

Notification and visa for advertising to the public at large

Number of evaluated advertising notifications 548 580 562 420

Number of visa applications for radio/TV advertising 68 65 94 89

Number of visa applications for radio/TV information campaigns 3 1 0 1

Submitted RMA files

38 42 51 64


PROPER USE DIVISION

Proper Use Division

Information & Documentation

Entity


Database of Medicinal Products

Entity

Advertising Entity

RMP – Risk Management

Plan Entity


Director-General of the

DG INSPECTIONManagement

Support

Administrative Support

Data Management Entity

Detection Entity


Authorisations, Declarations & Certificates

Entity

Recognition Human Tissue Material Entity

Establishment of Pharmacies

Entity

Register of the Pharmacies Entity

Special Regulated Substances

Entity

Precursors Team

Narcotics Team

Detached Customs Officers from FPS

Finance Team

Industry Division

Medicines GM(D)P Entity

Medicines GCP Entity

Medicines PhVig Entity


(NBs, fabrication, clinical studies)

Human Tissue Material & Blood

Entity

File Management Entity - Persons

Recognition

Rapid Alert Entity - Sampling Plan

Distribution Division

Distribution Entity &

Publicity Medical Devices

Distribution Entity & Publicity

Medicines

Detached Inspectors/

Controllers Entity

File Management Entity

Public Pharmacies Entity

Hospital Pharmacies/Medicinal Stocks

at Healthcare Professionals Entity

Medicinal Stocks at Veterinarians

Entity


Dispensing Division

Special Investigation Unit

DIRECTORATE-GENERAL INSPECTIONcompetent for all inspection and control activities

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KEY TASKS

The tasks of the Industry Division include both testing in the field and administrative checks on numerous partners. This concerns activities of the industry for industrial and pharmacy made raw materials, the phar-maceutical industry, MAH, blood institutions, human tissue or HTM banks and the medical devices industry. Up until September 2014 the division’s tasks also included checks on the distributors of medicines, of Active Pharmaceutical Ingredients (APIs) and of me-dical devices. From September 2014 onwards, the tasks of the Industry Division were split and divided between the Industry Division and new Distribution Division, which is focused on checking the distribution channels for APIs, medicines and medical devices, and checks on advertising and other promotional activities for medicines and health products.

The activities of the Industry Division are focused on the correct application of the regulations and the technical directives in the following areas: • Good Clinical Practices (GCP), collection of data

from the trials and protection of participating pa-tients, regardless of the status of the products used: medicines, medical devices, blood, cells and tissue;

• Good Manufacturing Practices (GMP) in the field of the manufacture of medicines as well as APIs and

raw materials for pharmacy made preparations; • pharmacovigilance, specifically the collection and

assessment of the data provided by the MAH such as reports of suspected adverse reactions and other safety issues;

• the manufacture of medical devices including oversight of the notified bodies;

• blood banks and MLM-MCH banks.

In addition to establishing the Distribution Division, the major change has been expansion of the team. The new staff members, including inspectors, file mana-gers and administrative staff, have nearly finished their training and will soon be able to assume their new roles. This reinforcement is already being felt in the number of consultation meetings with the sector and the number of days of fieldwork.


See more in the DG INSPECTION overview table.

Industry Division

Medicines GM(D)P Entity

Medicines GCP Entity

Medicines PhVig Entity


(NBs, fabrication, clinical studies)

Human Tissue Material & Blood

Entity

File Management Entity - Persons

Recognition

Rapid Alert Entity - Sampling Plan

INDUSTRY DIVISION

KEY TASKS

This new division was created in September 2014. The Distribution Division took over a part of the tasks of the Industry Division and is focused on the inspection of the distribution channels for Active Pharmaceutical Ingredients (APIs), medicines and medical devices, as well as checks on advertising and other promotional activities for medicines and health products.

DISTRIBUTION DIVISION


Distribution Division

Distribution Entity &

Publicity Medical Devices

Distribution Entity & Publicity

Medicines

Detached Inspectors/

Controllers Entity


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KEY TASKS

Inspection of retail pharmacies, hospital pharmacies and medicinal stocks at veterinarians.

In 2014 a team of inspector pharmacists/vets carried out inspections into retail pharmacies, hospital phar-macies and medicinal stocks at veterinarians.

In September 2014 a new entity was created with-in the Dispensing Division: the Hospital Pharmacies/ Medicinal Stocks at Healthcare Professionals Entity. This entity currently counts six inspectors and four trainees. Four inspectors are focused primarily on is inspection of medical devices in hospitals. In a subsequent phase, their activities will be expanded to cover other areas such as the central sterilisation departments in hospi-tals and the activities of dentists and ophthalmologists as well as private clinics.These inspectors are directly involved in drawing up the checklists and procedures related to the introduction of this new area for inspection.

As well as the standard routine checks, they also con-ducted more specific theme actions. In order to improve communication around effectiveness of the inspections, these sorts of actions are governed by much closer communication in respect of upcoming checks and any potential sanctions that may result.

Another valuable facet of the impact of the inspection team is the regular collaboration with a variety of legal prosecutors for various files relating to medicines and health products.

As well as actions in the field, the inspectors from the Dispensing Division also took part in countless consul-tation meetings with the respective sector and worked on transversal projects with a view to the revision, improvement or design of regulations. The inspectors of hospital pharmacies worked mainly with the con-sultation groups set up to fully rewrite the regulations relating to instructions for hospital pharmacists.Inspectors for retail pharmacies ensured the basis for the consultation group in relation to the regulations for permanent development of those pharmacists.



DISPENSING DIVISION

Public Pharmacies Entity

Hospital Pharmacies/Medicinal Stocks

at Healthcare Professionals Entity

Medicinal Stocks at Veterinarians

Entity


Dispensing Division

KEY TASKS

The Authorisations Division was set up in 2012 in order to consolidate handling of the whole range of autho-risations within one division in the DG INSPECTION. Its inspectors provide input for handling authorisa-tion applications. The inspectors’ conclusions and the authorisations granted are essential elements of the control policy that determines inspection planning.

The key tasks of the Authorisations Division are recei-ving authorisation applications, validating such appli-cations and ultimately delivering authorisations.

This includes: • manufacturing authorisations (GMP); • authorisations for manufacturing, import and dis-

tribution of APIs; • notification of medical brokers; • wholesale authorisations; • export declarations; • Certificates of Pharmaceutical Products (PPs); • accreditations for blood, cells and tissues; • authorisations of establishments of retail

pharmacies; • registrations of pharmacies; • authorisations of substances that fall under the

RD of 12 April 1974; • drugs precursors that need to meet the United

Nations (UN) Convention of 1988;

• narcotic substances and psychotropic materials that need to meet the UN Convention of 1961 and 1971.

MAs are not handled by this division, rather within the DG PRE authorisation and the DG POST authorisation.

The main realisations for 2014 were in the area of authorisations for narcotics and for GMP or GDP.

With regard to narcotics, the web interface for autho-risation applications became fully operational this year. Industrial operators can now submit their applications online. Eliminating the manual processing within the famhp not only reduces the risk of error, but also ena-bles the applications to be processed more rapidly.

The division also significantly streamlined the admin-istrative processes for GMP and GDP whereas in the past, for historical reasons, a Belgian model and a European model were issued, a clear choice has now been made to work exclusively with the European model. This European model, for which a GDP variant was also made available in 2014, is recognised within the European Union and is available in the Eudra GMDP database of the EMA. Moreover, the European model is more convenient as a list of medicines no longer needs to be attached. All of these measures will enable faster and more accurate processing.

AUTHORISATIONS DIVISION



Authorisations, Declarations & Certificates

Entity

Recognition Human Tissue Material Entity

Establishment of Pharmacies

Entity

Register of the Pharmacies Entity

Special Regulated Substances

Entity

Precursors Team

Narcotics Team

Detached Customs Officers from FPS

Finance Team

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Our colleague Roy Vancauwenberghe lost the fight against his illness in the night of November 28, 2014. Since September 1991 Roy worked at the General Pharmaceutical Inspection and within the famhp he was the great inspirer of the Special Investigation Unit of the DG INSPECTION.

KEY TASKS

The key task of the Special Investigation Unit (SOE-USE) is combating illegal trade in medicines and health products. This involves official investigations, assistance in prosecutions and checks of postal packages from third countries.

In 2014 assistance was provided for judicial investiga-tions in 129 files. This figure is unchanged since last year. However, in 2014 there was a sharp increase in the number of posted items that were checked. A total of 3,781 posted items were seized and 176 larger shipments were checked in transit. That these posted items represent a significant increase in files is reflected by the fact that a total of no fewer than 576 official investigations were carried out. Of these 576 files, 282 concerned substances regulated by the Royal Decree (RD) of 12 April 1974 with respect to some actions relating to materials with a hormonal, anti-hormonal, anabolic, beta-adrenergic, anti-infectious, antiparasitic and anti-inflammatory effect (mainly doping) and 294 concerned other medicines.

Given the unit’s transversal role, the activities of the SOE-USE involve intensive internal collaboration with other divisions of the DG INSPECTION. At the national level, there is an important network for collaboration between the judicial authorities, police, customs, the Federal Agency for the Safety of the Food Chain (FASFC)

and the FPS Economy through various forms of multidis-ciplinary consultation, chief among which is the opera-tional consultation within the Multidisciplinary Hormone Entity, the network of between points of contact be-tween various government authorities and agencies is.

It should also be noted that in the fight against illegal practices on the Internet, in 2014 close collaboration was established with the Cybersquad of the Customs authorities, primarily because many of the intercepted parcels had been ordered over the Internet.

In addition to participation in various platforms for combating fraud nationally, in 2014, the SOE-USE was involved in numerous international initiatives, chief among which are: • Pangea VII, the International operation to combat

the online sale of falsified medicines and other illegal medicines coordinated by Interpol in 2014;

• meetings of the Working Group Enforcement Officers (WGEO) of the Heads of Medicines Agencies (HMA) for consultation related to the fight against pharmaceutical crime;

• meetings of the Committee of Medical Experts ( CMED) of the European Council for combating crime.



Special Investigation Unit


Activity 2011 2012 2013 2014

Number of inspections

retail pharmacies 667 414 319 602

hospital pharmacies 83 60 51 68

medicinal stocks at veterinarians 538 524 476 448

pharmaceutical companies – GMP 87 264* 205 221*

pharmaceutical companies – GDP 130 - - n/a*

number of official reports

inspectors of retail pharmacies 189 144 131 171

inspectors of hospital pharmacies 2 10 1 13

inspectors of the pharmaceutical industry 10 43 34 52

Narcotics and psychotropic substances, number

inspections of stock and accounts at manufacturers, wholesale-distributors, importers and exporters (Fr) 197 242 277 256

licence reviews – import (Fr) 309 340 399 412

licence reviews – export (Fr) 33 64 150 178

inspections of stock and accounts at manufacturers, wholesale-distributors, importers and exporters (Nl) 237 219 231 297

licence reviews – import (Nl) 620 997 1,073 1,193

licence reviews – export (Nl) 86 82 76 93

Narcotics and psychotropic substances, import/export licences

number 7,088 7,157 7,499 8,155

average period for issuing this license 8 days 4 days 4 days 2 days

FIGURES FOR THE DG INSPECTION

Note is:* Total number GMDP-inspections, there is no distinction made between GMP and GDP inspections.

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Activity 2011 2012 2013 2014

Narcotics and psychotropic substances, narcotics order forms (per 100 forms)

number 6,052 5,607 5,672 6,019

average period for sending the narcotics order forms 5 days 4 days 3 days 2 days

Precursors, number

activity licences to market participants 94 65 92 102

import/export licences – export 408 435 454 672

import/export licences – import 29 25 29 7

import/export licences – Pre Export Notifications (PENs) 376 330 380 664

import/export licences – intra-community trade 3,227 2,016 2,489 -

import/export licences – suspicious orders and transactions 64 64 59 61

Hormones and antibiotics, number

new licences (Nl) 56 62 45 40

renewals (Nl) 139 139 66 71

extension of certificates (Nl) 215 167 151 138

new licences (Fr) 61 36 33 29

renewals (Fr) 72 86 69 33

extension of certificates (Fr) 91 71 96 87

Export, number

EUDRA-certificates 68 89 94 116

EUDRA-repeat orders - 608 694 1,006

GMP-certificates 888 624 767 469

certificates of Pharmaceutical Products (PP) 3,382 3,228 3,044 3,154

certificate for Medical Device (CMD) 848 See DG POST authorisation

other certificates (e.g. certified copies, analysis reports) 539 435 856 823

export declarations 159 172 227 217

declarations of toll manufacturing activity 135 131 145 100


Activity 2011 2012 2013 2014

RAS of quality, of which

of Belgian origin 111 129 142 134

of European origin 141 137 182 168

of class 1 55 62 84 81

of class 2 117 136 150 144

of class 3 50 44 42 31

unclassified 0 1 1 2

fraud/counterfeit 30 23 47 44

for medicines for human use 219 241 291 272

for medicines for veterinary use 20 17 23 25

for raw materials 5 2 2 3

for medicines for research or Investigational Medicinal Products (IMPs) 8 3 7 2

Total 252 266 324 302

“14.12.2006” and “30.06.2004” licences, number

new applications 23 24 29 53

applications for amended licences 171 174 172 203

Number of applications for variations submitted to the Advisory Commission

urgent applications 29 19 33 21

applications processed according to normal procedures 89 73 94 111

Commission for the establishment of retail pharmacies, French language chamber, number

applications 48 85 93 129

decisions 36 87 78 97

Registry of pharmacies, French language chamber, number

applications for amendments 441 396 591 436

current applications (monthly average) 120 152 200 203

attestations/authorisations delivered 403 448 452 570

51

Dire

ctor

ate-

Gen

eral

INSP

ECTI

ON

Activity 2011 2012 2013 2014

Commission for the establishment of retail pharmacies, Dutch language chamber, number

new applications 77 90 104 436

ministerial decisions 78 88 111 203

Registry of pharmacies, Dutch language chamber, number

application for amendments 649 611 864 907

current applications (monthly average) 176 59 171 79

attestations/authorisations delivered 567 517 740 720

SOE-USE

number of applications: infringements of the RD of 12 April 1974 54 67 132 282

number of applications: other infringements of medicinal products regulations (other than the RD of 12 April 1974) 142 60 153 294

warnings 35 41 21 29

assistance to public prosecutors number of opened files 53 47 128 129

number of postal packages inspected 1,078 1,072 1,989 3,781

number of transit files (Bierset) 222 118 252 176

Recognition of pharmacists-clinical biologists

French language chamber’s, number - - - -

new training plans 8 7 8 7

approvals issued 5 8 8 9

Dutch language chamber, number - - - -

new training plans 10 10 6 12

approvals issued 14 10 7 23


Co-ordinator of B&BMc & ICT-strategie

Division


B&Mc Division


B&Mc

Logistics

Translation UnitICT Division


MeSeA & Filenet

Projects and Development


Portals, Intranet, TQM, Cockpit, Architecture,

Capacity planning, Projects

Helpdesk Infrastructure

SUPPORT SERVICES

53

Supp

ort

Serv

ices

KEY TASKS

DThe main tasks of the B&MC Division (budget and management control) are:

• compiling and monitoring the annual budget; • recording income and expenditure; • compiling the annual financial accounts; • paying invoices; • logistics or service provision.

2014 saw the integration of and the targeted support for the decentralised bookkeeping activities. For the sake of greater efficiency, certain financial activities will be directly managed by the operational divisions. In 2014, the B&MC Division developed a collaboration with these divisions in order to optimise the integration of these transactions. For the processing of payments by pharmacies related to narcotics as well as transfers of the contributions for the sale of medical devices, each manager underwent a specific information ses-sion in order to ensure smooth integration into the accounting software of the famhp.

This approach was also applied for expenditures. Thanks to the appointment of a head of management control, the famhp is now able to document the expenditures as a whole, in order to enable accurate day-to-day monitoring of the budget. The B&MC Division is now systematically tracking the evolution of expenditures

in order to prevent any overruns and to ensure the correct use of the allocated budgets.

The monitoring of the income and expenditures and the professionalism of the individuals involved was emphasised in the most recent report by the company auditors concerning the 2013 annual accounts, in which the method of working was described as accurate and transparent. The number of recommendations has been radically reduced and now generally concern manage-ment advice rather than regularisation transactions.

The division also devoted attention to the external partners of the famhp. The B&MC Division drew up a plan in steps with a checklist and practical tips for the approval of the financial reports of the institutions subsidised by the famhp. Thanks to this plan, the bud-getary transparency of these institutions was increased.

In 2014 the B&MC Division made a conscious choice to modernise its activities. Examples of this include the development of a standard document for invoices that is better adapted to the current requirements, the definition and follow-up of monthly indicators for the workload and organisation of systematic consultation between the staff member in charge of “budget” and the one in charge of Logistics, either through bilate-ral meetings with each department of the famhp or through meetings of the network of SPOCs (single points of contact).

B&Mc Division


B&Mc

Logistics

B&MC DIVISION


An important project for the famhp remains the ProCost project, the aim of which is to measure the real cost of the activities within the famhp. The B&MC Division took the lead in developing a measuring instrument for the real costs of the activities and services of the famhp. Thanks to the collaboration of all of the depart-ments, the famhp will be better able to demonstrate the quality and efficiency of its processes in the future.

A modernisation project was also launched for the Logistics services. From now on, every requests made to Logistics will be electronically recorded and valida-ted. This digitisation will enable effective monitoring of the activities, improvement of customer satisfaction and better distribution of the workload.The famhp is also increasingly participating in a range of trade fairs. The logistical support provided for the organisation of these events is highly appreciated by the services involved and is regarded as being of high quality.


See the Some Budgetary Elements section.

KEY TASKS

De key tasks of the ICT Division are made up of meet-ing the IT needs of the famhp -staff and partners. As part of their day-to-day responsibilities, the ICT teams provide support to all famhp staff in terms of IT ser-vices and equipment, in line with the strategic goals of the famhp.

The ICT Division is divided into: • Helpdesk This section ensures the installation of computer

material such as computers (PC), keyboard/mouse and telephones, registers all intervention requests relating to software and hardware and tries to resolve problems as quickly as possible. The main-tenance and management of the IT material and technical equipment, maintenance of the network and the mainframe and the necessary operations in the patching room are intended to ensure the optimal functioning of the IT material and to give users access to the necessary equipment at all times.

• Infrastructure This section manages the network, network

rights, databases (such as Oracle), working en-vironments (such as Windows), manages and maintains the servers and maintains supervision of the dataroom..

ICT DIVISION

ICT Division


MeSeA & Filenet

Projects and Development


Portals, Intranet, TQM, Cockpit, Architecture,

Capacity planning, Projects

Helpdesk Infrastructure

55

Supp

ort

Serv

ices

• Projects and Development This section is responsible for the specific appli-

cations of the various sections of the famhp and for the development of new applications for ICT projects within the famhp and with the famhp partners.

Total number of intervention requests made to the Helpdesk

2011 2012 2013 2014

3,276 3,140 3,569 3,631

Top five intervention requests made to the Helpdesk 2014

1 Problem with software or application 421

2 Software installation 402

3 Problem with e-mails or Outlook-archive 284

4 Application for network access 273

5 Problems or questions related to software 271

- The new application/module for managing files for homeopathic medicines was officially delivered.

- Improvements were made to MeSeA VET and thanks to the common codebase approach, this was also instantly made available in the MeSeA application for the management of files for ho-meopathic medicines.

- The MeSeA applications have a disaster recovery plan (DRP environment). In the event of serious problems with the production environment, such as for example, a fire in the server room, we can switch over to a reserve environment.

- A complete monitoring-environment was in-stalled on the MeSeA applications (hardware, storage, network and applications). This should enable us to proactively monitor critical system resources (such as storage, network capacity, server capacity) and also actively monitor the service level agreement (SLA) and provide users


In 2014 the ICT Division, specifically the Projects & Developments and Infrastructure teams, working close-ly with the ICT network of Single Points of Contact (SPOCs) and respective staff from other famhp di-visions, successfully completed a series of projects, such as:

• MeSeA (the Medicines e-Submission and e- Approval system)

- MesExtra UI was put into production. This is a new module that manages the data on authorised medicines in a clear manner, via a new interface.

- The patient information leaflets approved via the central procedure for MA are now no longer displayed on the website as a single large docu-ment, but have been divided into separate files, per language group.

- The module for medicines for veterinary use now has a functionality offering a convenient way to perform complex searches.


with more targeted information in the event of problems.

- A DEMO project was developed in order to il-lustrate the potential of content analytics in the MeSeA applications.

- A proof of concept was delivered for the purpose of carrying out the filenet 5.2-migration in 2015; in addition, a vision was drafted indicating what the next steps in the programme should be after the filenet 5.2-migration (both technical and on behalf of the user).

- MeSeA Helpdesk support was launched in order to provide fast, reliable IT support in direct con-tact with the users.

• Hosting for the interactive website for the Ethics Committees in Belgium and hosting for haemovigilance was provided via a tender procedure.

• Extra plus revised New release in order to map the availability of

medicines in Belgium.

• Common European Submission Platform (CESP) Connector.

This is an automatic connector to CESP, the European platform for the electronic submission of MA and registration files for medicines for human and vete-rinary use. A modification was carried out within the

Irish authority HPRA as well as within the famhp in order to be able to automatically distribute answers to questions. A mechanism was also implemented that automatically detects double uploads.

• Sharepoint-platform The use of a document management system

(DMS) light was realised for a larger number of users:

- definition of the governance-rules; - procedure for the rapid creation of websites using

standard documents; - use of conference rooms; - management of legislation files.

• Traceability system of implantable medical devices

In April 2014 the system was put into production for a pilot project involving a limited

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