COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Amendment of the financial statement accompanying Regulation (EC) No 297/95
Date: 2012-09-25
Institutions: European Commission
Subjects: European Medicines Agency, financial management, financing, tax

EUROPEAN COMMISSION 

Brussels, 25.9.2012  
COM(2012) 543 final 

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL 
COMMITTEE AND THE COMMITTEE OF THE REGIONS 

Amendment of the financial statement accompanying Regulation (EC) No 297/95 

EN 

   EN 

 
 
 
  
 
COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL 
COMMITTEE AND THE COMMITTEE OF THE REGIONS 

Amendment of the financial statement accompanying Regulation (EC) No 297/95 

Regulation  (EC)  No 726/2004  of  the  European  Parliament  and  of  the  Council  of  31  March 
20041 laying down Community procedures for the authorisation and supervision of medicinal 
products for human and veterinary use and establishing a European Medicines Agency, set up 
the  European  Medicines  Agency,  repealing  Council  Regulation  (EEC)  No 2309/932.  Article 
67(3)  of  this  regulation  establishes  that  the  revenue  of  the  Agency  shall  consist  of  a 
contribution from the European Union, and the fees paid by the undertaking for obtaining and 
maintaining  a  Community  marketing  authorisation  and  for  other  services  provided  by  the 
Agency.  

Council  Regulation  (EC)  No 297/95  of  10  February  19953  on  fees  payable  to  the  European 
Medicines Agency ('EMA') sets out the different types of fees payable for services provided, 
including the possibility for waivers and reductions of certain fees. 

For  neither  the  establishment  of  Regulation  (EC)  No 297/95  nor  its  amendments  in  19984, 
20035  and  20056  the  corresponding  financial  statements  (if  applicable)  provided  for  the 
human resource element required to handle fee-related applications.  

The Budgetary Authority agreed to additional staff for fee-related activities in 2010. For 2011 
and  2012  no  additional  fee-financed  staffing  was  provided;  the  additional  posts  agreed  for 
2012  correspond  to  the  implementation  of  the  new  pharmacovigilance  activities  only.  In 
DB2013  the  Commission  agreed  on  an  increase  of  the  EMA  establishment  plan  with 
21 additional posts, to be financed by fees from the industry. With this Communication, the 
Commission  wants  to  address  the  justification  of  this  increase.  In  fact,  the  fee-related 
activities of EMA have developed substantially since 2010, with the consequential expansion 
of the workload for the Agency, yet with no corresponding increase in staff.  

To  provide  for  the  evaluation  of  medicines,  the  Agency  needs  to  hire  highly  specialised 
administrators, who are to follow a lengthy and costly on-the-job training. As a consequence, 
for long-term increases in workload, the Agency has to recruit temporary agents rather than 
contract  agents.  The  latter  are  recruited  for  short-term  increases  in  workload  as  well  as  for 
project  related  work.  As  the  Agency  is  scaling  down  project-related  work,  the  number  of 
contract agents can be reduced. At the same time, fee-related income of the Agency, based on 
Recovery  Orders/invoices  sent7,  increased  from  EUR  171,9  million  in  2010  to  EUR  179,8 
million  in  2011  and  is  estimated  to  further  increase  to  EUR  200,8  million  in  2013.  This 

1 
2 
3 
4 
5 
6 
7 

OJ L 136, 30.4.2004, p. 1, as last amended by Regulation No 1235/2010 (OJ L 348, 15.12.2010). 
OJ L 214, 24.8.1993, p. 1. 
OJ L 35, 15.2.1995, p. 1. 
OJ L 345, 19.12.1998, p. 3. 
OJ L 73, 19.3.2003, p. 6. 
OJ L 304, 23.11.2005, p. 1. 
As  opposed  to  the  amount  of  Recovery  Orders  cashed,  which  is  important  to  determine  the  level  of 
revenues for budgetary purposes. 

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corresponds to a 5.9% increase for the period 2010-12 and a 16.8% increase over the period 
2010-13, which translates into the corresponding increase in workload.  

These recent developments in fee-related activities are of a long-term nature and the Agency 
requires  21  additional  temporary  agents  as  of  2013.  While  asking  for  this  increase,  the 
Agency  has  taken  into  account,  in  accordance  with  the  Commission  proposal,  to  reduce  its 
staff with 5% over 5 years as from 2013 and also considered all means of redeployment and 
process improvement. 

It  needs  to  be  highlighted  as  well  that  the  current  fee-financed  increase  in  staffing  is  not 
linked to the implementation of the new pharmacovigilance legislation, applicable as of July 
2012.  It  is  currently  estimated  that  the  Agency  will  be  in  a  position  to  charge  fees  for 
pharmacovigilance  activities,  as  foreseen  in  the  legislation,  in  2014  at  the  earliest.  Related 
staff  covered  by  the  anticipated  fee  income  will  only  be  requested  as  and  when 
pharmacovigilance fees are estimated to be received.  

On  the  basis  of  the  elements  mentioned  above,  it  is  necessary  to  update  the  legislative 
financial statement. The new statement is attached herewith. 

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REVISED LEGISLATIVE FINANCIAL STATEMENT 

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE 

1.1.  Title of the proposal/initiative 

1.2.  Policy area(s) concerned 

1.3.  Nature of the proposal/initiative 

1.4.  Objective(s)  

1.5.  Grounds for the proposal/initiative 

1.6.  Duration and financial impact 

1.7.  Management mode(s) envisaged 

2. 

MANAGEMENT MEASURES 

2.1.  Monitoring and reporting rules 

2.2.  Administration and controls 

2.3.  Measures to prevent fraud and irregularities 

3. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE 

3.1.  Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget 
line(s) affected 

3.2.  Estimated impact on expenditure 

3.2.1. Summary of estimated impact on expenditure 

3.2.2. Estimated impact on operational appropriations 

3.2.3. Estimated impact on appropriations of an administrative nature 

3.2.4. Compatibility with the current multiannual financial framework 

3.2.5. Third-party contributions 

3.3.  Estimated impact on revenue 

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1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE 

1.1. 

Title of the proposal/initiative 

Council  Regulation  (EC)  No 297/95  of  10  February  1995  on  fees  payable  to  the  European 
Medicines Agency – amendment of the financial statement. 

1.2. 

Policy area(s) concerned in the ABM/ABB structure8 

Policy Area(s) concerned: Heading 1a – Competitiveness for Growth and Employment 

1.3. 

Nature of the proposal/initiative 

(cid:133) The proposal/initiative relates to a new action 

(cid:133)  The  proposal/initiative  relates  to  a  new  action  following  a  pilot  project/preparatory 
action9 

(cid:59) The proposal/initiative relates to the extension of an existing action 

(cid:133) The proposal/initiative relates to an action redirected towards a new action 

1.4. 

Objectives 

1.4.1.  The Commission's multiannual strategic objective(s) targeted by the proposal/initiative 

To  harness  European  economic  integration  (the  "single  market")  to  the  broader  goal  of 
sustainable growth by mobilizing economic, social and environmental policies.  

1.4.2. 

Specific objective(s) and ABM/ABB activity(ies) concerned 

Specific objective 

The EMA shall levy fees to the pharmaceutical industry for obtaining and maintaining an EU 
market authorisation for medicinal products for human use and for other services rendered by 
the Agency. 

ABM/ABB activities concerned 

Heading 1A – Competitiveness for Growth and Employment  

17 03 10: EUROPEAN MEDICINES AGENCY 

8 
9 

ABM: Activity Based Management – ABB: Activity Based Budgeting. 
As referred to in Article 49(6)(a) or (b) of the Financial Regulation. 

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Expected result(s) and impact 

Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted. 

In  light  of  the  continous  increase  in  the  activities  of  the  Agency,  notably  the  number  of 
applications  in  the  pre-  and  post-authorisation  phase  of  the lifecycle  of  a  medicinal  product, 
the number of staff dealing with these applications which are also increasingly complex, needs 
to increase at a proportional level. The initial financial statement should therefore be revised to 
adapt  to  the  reality  of  the  agency's  staffing  needs.  The  extra  staff  will  be  funded  by  the  fee 
income generated through these activities and is therefore neutral for the EU budget.  

a) Increase in activities e.g. numbers of applications/workload 

Applications for designation of orphan medicinal products (input) 

Applications for designation of MUMS 

PIP applications including waivers and deferrals 

Clinical indications in PIP applications 

Modification of agreed PIPs 

Scientific advice and follow-up requests (HUM) 

Protocol assistance and follow-up requests (HUM) 

Scientific Advice (VET) 

New medicinal products (non-orphan) (HUM) 

New medicinal products (orphan) (HUM) 

Similar biological products (HUM) 

Generic, hybrid products, etc. (HUM) 

Scientific opinions for non-EU markets (HUM) 

Paediatric use market. authorisat. (HUM) 

Advanced therapy re-registration * (HUM) 

Applications for new medicinal products (VET) 

Generic applications (VET) 

Type-IA variations (HUM) 

Type-IB variations (HUM) 

Type-II variations (HUM) 

Line extensions (HUM) 

Type-I variation applications (VET) 

Type-II variation applications (VET) 

Line-extension applications (VET) 

Certificates requested 

New MRL applications 

MRL ext./mod. applications 

MRL extrapolations 

MRL for use under the 'cascade' 

Art. 9, Biocides 

Review of draft Codex MRLs 

2009 

164 

4 

273 

364 

311 

77 

11 

36 

11 

1 

48 

0 

0 

14 

1 

897 

470 

1.186 

24 

73 

40 

12 

2010 

2011 

2012 est. 

2013 est. 

174 

18 

326 

403 

110 

332 

68 

21 

34 

12 

1 

42 

1 

1 

0 

16 

2 

166 

18 

187 

220 

177 

354 

79 

26 

47 

14 

3 

33 

1 

1 

1 

8 

3 

2.057 

1.093 

2.875 

1.260 

966 

29 

134 

28 

3 

873 

31 

241 

46 

7 

180 

18 

220 

258 

225 

413 

80 

26 

52 

13 

5 

39 

1 

0 

2 

9 

3 

3.300 

1.350 

870 

25 

275 

52 

7 

185 

18 

220 

226 

280 

454 

89 

26 

56 

13 

3 

38 

0 

2 

10 

3 

3.700 

1.400 

870 

25 

310 

65 

7 

2.144 

2.396 

3.104 

3.200 

3.400 

1 

8 

5 

4 

2 

0 

6 

3 

4 

0 

4 

6 

3 

4 

2 

1 

3 

5 

2 

5 

3 

1 

3 

2 

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Art. 13 of Reg. (EC) No 1234/2008 (HUM) 

Art. 6(12) of Reg. (EC) No 1084/2003 (HUM) 

Art. 6(13) of Reg. (EC) No 1084/2003 (HUM) 

Art. 31 of Dir. 2001/83/EC (HUM) 

Art. 36 of Dir. 2001/83/EC (HUM) 

Art. 5(3) of Dir. 2001/83/EC (HUM) 

Art. 107(2) of Dir. 2001/838/EC (HUM) 

Art. 29(4) of Dir. 2001/83/EC (HUM) 

Art. 30 of Dir. 2001/83/EC (HUM) 

Art. 29 of Reg. (EC) No 1901/2006 (HUM) 

Art. 20 of Reg. (EC) No 726/2004 (HUM) 

Art. 20 foll. Art. 20 proc. of Reg (EU) 1235/2010 (HUM) 

Art. 20 foll. Art. 107j(2) proc. of Dir. 2010/84/EU (HUM) 

Art. 20 foll. Art. 107i proc. of Dir 2010/84/EU (HUM) 

Art. 31 foll. Art. 32-34 of Dir. 2001/83/EC (HUM) 

Art. 31 foll. Art. 107j(2) proc. of Dir. 2010/84/EU (HUM) 

Art. 107i of Dir. 2010/84/EU (HUM) 

Arbitration and Community referral procedures (VET) 

GMP inspections (including PMF) 

GCP inspections 

Pharmacovigilance inspections 

GLP inspections 

Parallel-distribution Initial notifications 

Parallel-distribution Notifications of change 

Number of quality defects reported 

0 

0 

0 

6 

0 

3 

3 

6 

8 

1 

1 

2 

0 

10 

5 

7 

2 

2 

6 

0 

28 

42 

- 

- 

- 

- 

- 

- 

12 

229 

62 

5 

4 

2.599 

4.590 

111 

- 

- 

- 

- 

- 

- 

12 

375 

65 

9 

1 

2.551 

2.150 

154 

5 

1 

4 

0 

2 

5 

13 

10 

6 

- 

- 

- 

- 

- 

- 

9 

175 

58 

- 

0 

2.247 

5.527 

80 

1 

5 

1 

5 

2 

5 

3 

8 

6 

2 

6 

1 

4 

3 

12 

330 

65 

9 

2 

2.600 

2.000 

177 

5 

5 

3 

11 

5 

10 

2 

11 

7 

12 

360 

70 

10 

2 

2.800 

1.600 

218 

b) Increase  in  revenue from fees and charges (based on Recovery Orders/Invoiced amounts) 
compared to posts: 

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2010 Outturn 

2011 Outturn 

2012 

2013 PDB 

Total 
increase 
2010-2011 

Total increase 
2010-2012 

Total increase 
2010-2013 

Revenue 

Fees+charges (Recovery Orders) 

171.972.868 

179.791.829 

182.155.000 

200.797.000 

7.818.961 

10.182.132 

28.824.132 

Increase n/n-1 

4,55% 

1,31% 

10,23% 

4,55% 

5,92% 

16,76% 

Posts 

- of which for fee related activities 

- of which for general public health 
policies 

-  of  which  for  pharmacovigilance 
legislation 

=  net  increase  fee  related  tasks 
n/n-1 

567 

457 

110 

0 

567 

457 

110 

0 

590 

457 

110 

23 

611 

479 

109 

23 

0 

0 

0 

0 

23 

0 

0 

23 

44 

22 

-1 

23 

0,00% 

0,00% 

4,81% 

0,00% 

0,00% 

4,81% 

Please note that the amounts for fees and charges mentioned in the table above are based upon 
the recovery orders/invoices sent. For budgetary purposes, the amount of the recovery orders 
cashed is taken into account. 

1.4.3. 

Indicators of results and impact 

Specify the indicators for monitoring implementation of the proposal/initiative. 

N/A 

1.5. 

Grounds for the proposal/initiative 

1.5.1.  Requirement(s) to be met in the short or long term 

In accordance with Article 27 (6) of the EMA Financial Regulation (based on the Framework 
Financial  Regulation),  the  budgetary  authority  shall  adopt  the  establishment  plan  of  the 
Agency. The Agency informs its partner DG (DG SANCO) of its budgetary and staffing needs 
for n+2 with its annual financial statement.  

The EMA is financed at 80-85% by fees from the pharmaceutical industry and at 15-20% by 
an EU balancing contribution. The Agency must be enabled to recruit sufficient staff, financed 
by fee income, to process the applications for which fees are paid.  

1.5.2.  Added value of EU involvement 

As  indicated  in  recital  21  of  Regulation  (EC)  No 726/2004,  the  Agency’s  budget  should  be 
composed  of  fees  paid  by  the  private  sector  and  contributions  paid  out  of  the  Community 
budget to implement Community procedures. 

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1.5.3.  Lessons learned from similar experiences in the past 

N/A 

1.5.4.  Coherence and possible synergy with other financial instruments 

N/A 

1.6. 

Duration and financial impact 

(cid:59) Proposal/initiative of unlimited duration 

–  Implementation from 2013 

–  followed by full-scale operation. 

1.7.  Management mode(s) envisaged10 

(cid:133) Centralised direct management by the Commission 

(cid:59) Centralised indirect management with the delegation of implementation tasks to: 

–  (cid:133)  executive Agencies 

–  (cid:59)  bodies set up by the Communities11 

–  (cid:133)  national public-sector bodies/bodies with public-service mission 

–  (cid:133)  persons entrusted with the implementation of specific actions pursuant to Title V of the 
Treaty  on  European  Union  and  identified  in  the  relevant  basic  act  within  the  meaning  of 
Article 49 of the Financial Regulation 

(cid:133) Shared management with the Member States 

(cid:133) Decentralised management with third countries 

(cid:133) Joint management with international organisations (to be specified) 

If more than one management mode is indicated, please provide details in the ‘Comments’ section. 

Comments 

10 

11 

Details  of  management  modes  and  references  to  the  Financial  Regulation  may  be  found  on  the  BudgWeb  site: 
http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html 
As referred to in Article 185 of the Financial Regulation. 

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2. 

MANAGEMENT MEASURES 

2.1.  Monitoring and reporting rules 

Specify frequency and conditions. 

N/A  

2.2. 

Administration and controls 

2.2.1.  Risk(s) identified 

N/A 

2.2.2.  Control method(s) envisaged 

The  Agency’s  accounts  will  be  submitted  for  the  opinion  of  the  Court  of  Auditors,  and 
subject  to  the  discharge  procedure.  The  Commission’s  Internal  Audit  Service  will  be  the 
agency's internal auditor. 

2.3.  Measures to prevent fraud and irregularities 

Specify existing or envisaged prevention and protection measures. 

The Agency is subject to monitoring by the Anti-Fraud Office. 

3. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE 

3.1. 

Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget  line(s) 
affected 

•  Existing expenditure budget lines 

The  increase  in  the  EMA  budget  expenditure  to  finance  21  additional  posts  for  the 
establishment plan as of 2013 will be fully covered by the fees paid by the industry.12 

12 

For more information, see Annex 1. 

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In order of multiannual financial framework headings and budget lines. 

Budget line 

Heading of 
multiannu
al financial 
framework  Number  

[Description…...….] 

17 03 10 01 – Title 1 and 2 

1a 

European Medicines Agency (EMA) – 
Expenditure 
administrative 
on 
management 

Type of 
expendi-
ture 

Differentiat
ed/Non-
differentiat
ed 
appropriati
ons 
13 

Contribution 

from 
EFTA 
countries
14 

from 
candidate 
countries15 

from 
third 
countries

within the 
meaning of 
Article 
18(1)(aa) 
of the 
Financial 
Regulation 

NDA 

YES 

No 

No 

No 

3.2. 

Estimated impact on expenditure 

3.2.1. 

Summary of estimated impact on expenditure 

The appropriations required for budget line 17.03 10 01/02/03 European Medicines Agency 
(EMA) remain unchanged. 

Heading of multiannual 
financial framework:  

DG SANCO 

TOTAL appropriations 
under HEADING 1a 
of the multiannual financial 
framework 

EUR million (to three decimal places) 

Number 1a 

Competitiveness for growth and employment 

Year 
201316 

Year 
2014 

Year 
2015 

TOTAL 

Commitments 

=4+ 6 

N.A 

N.A 

N.A 

N.A 

Payments 

=5+ 6 

N.A 

N.A 

N.A 

N.A 

3.2.2.  Estimated impact on operational appropriations 

–  (cid:59)  The proposal/initiative does not require the use of operational appropriations 

13 
14 
15 
16 

DA= Differentiated appropriations / NDA= Non-differentiated appropriations. 
EFTA: European Free Trade Association. 
Candidate countries and, if applicable, the western Balkan potential candidate countries. 
Year N is the year in which implementation of the proposal/initiative starts. 

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3.2.3.  Estimated impact on appropriations of an administrative nature 

3.2.3.1.  Summary 

–  (cid:59)  The proposal/initiative does not require the use of administrative appropriations 

3.2.3.2.  Estimated human resources requirements 

–  (cid:59)  The proposal/initiative does not require the use of human resources 

No additional human and administrative resources will be needed in DG SANCO as a result of this Legislative Financial Statement. 

3.2.4.  Compatibility with the current multiannual financial framework 

–  (cid:59)  Proposal is compatible with the current multiannual financial framework. 

No  change  in  appropriations  for  the  agency's  contribution  on  budget  line  17.0310.  Additional  staffing  will  be  financed  by  Agency’s  own 
resources financed by fees from pharmaceutical industry. 

3.2.5.  Third-party contributions 

–  (cid:59) Proposal/initiative does not provide for cofinancing by third parties 

EFTA contribution is due on the EU subsidy to the EMA, which is not impacted by the current proposal 

–  The proposal/initiative provides for the co-financing estimated below: 

3.3. 

Estimated impact on revenue 

–  (cid:59)  Proposal has no financial impact on revenue. 

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Annex 1: 

Indicative Budget, detailed description of additional posts and staffing forecast 

1. 

Indicative Budget 

The agency's indicative budget can be summed up as follows:  

Income 

2012 

2013 

Expenditure

2012 

2013 

Fees+Charges 182.255 190.370 

EU subsidies 

38.841

39.230 

Other 

1.393

1.474 

Title 1 

Title 2 

Title 3 

75.046

80.662 

32.700

36.199 

114.743 114.213 

Total income  222.489 231.074 

Total Cost 

222.489 231.074 

Expenditure titles 1 and 2 correspond to a revised total number of staff of 611 temporary agents (TAs), 125 contract agents (CAs) and 15 seconded 
national experts (SNEs) for 2013. 

2. 

Summary of the number of staff requested 

While asking for the increase of the staff requests for 2013, EMA has taken account of the fact that 2013 is the first year of application of the 5% staff 
reductions over five years as per the current proposal for the revised Staff Regulations (=1%/year). 

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As a consequence of the above, for 2013 EMA requests 21 additional posts with the following justification: 

Maximum staffing in FTE 

Fee related posts 

Non-fee related posts 

Total Posts 

Contract Agents (by year-end) 

National Experts (by year-end) 

Total staffing 

2012 

457 

133 

590 

132 

15 

737 

Reduction 1% as per 
instruction 

Increase in fee 
activities 5.9% 

-5 

-1 

-6 

27 

27 

2013 

479 

132 

611 

125 

15 

751 

Difference 
2013-2012 

22 

-1 

21 

-7 

0 

14 

EMA has applied the required 1% reduction in posts to both fee-related and non-fee related activities and has also reduced the number of Contract 
Agents. 

EMA  has  not  received  any  new  posts  for  increases  in  fee-related  activities  in  2011  and  2012.  For  2012  only  23  posts  were  agreed  for  the 
implementation of the Pharmacovigilance legislation.  

In calculating staffing requirements for 2013, despite an estimated increase in fee related workload over 16% (compared to 2010) only the average fee–
related workload increase between 2010 and 2012 (5.9%) has been taken into account (as shown in the table in point 1.4.3. b/). Estimated workload 
increases for the DB will have to be covered by internal staff re-allocation and process improvements, and by using Contact Agents when necessary 
and possible. 

3. 

Detailed description of additional posts 

EMA  is  financed  at  80-85%  from  fees  from  the  pharmaceutical  industry  for  services  provided  and  at  15-20%  by  a  balancing  subsidy  from  the 
European Union. Increases in fee-related workload need to be reflected with increases in staff if these increases are not just temporary but long-term. 

The detailed description of the additional posts requested as well as the justification for each of the posts is shown below. For information purposes, the 
annual average costs, including overheads, of an AD and AST staff member are estimated at 173.000 and 110.000 EUR respectively. As the EMA staff 

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is increased with 17 AD posts and 4 AST posts (this split is built on the actual EPP of the agency, adapted with 10% flexibility), the total additional 
annual cost is estimated at 3 381 000 EUR. However, the number of contract agents is decreased by 7. At an average cost of 105 000 EUR per contract 
agent, the decrease represents 735 000 EUR. The net impact of the staff changes is thus 2 646 000 EUR, fully financed by fees.  

Of the total 21 posts requested 15 are for the direct operational units, Patient Health Protection (P), Human Medicines Development and Evaluation (H) 
and Veterinary Medicines and Product Data Management (V). Two posts are for the Information and Communications Technology (I) unit, directly 
dealing with product related databases.  

Further four posts are for Administration (A) and Directorate (D). In this context it needs to be noted that support staff at the Agency is split for fee-
related and non-fee related support as per the proportion given by the activity-based time recording system in the Agency and the staff requests for 
additional support staff is linked to the increases in fee-related activities. 

Unit 

2012 
Total 
Posts 

Posts requested 

P 

161 

6 

1 

AD6 

1 

AD5 

Post Justifications 

To provide scientific and procedural support in the management of Community referrals and Opinions on scientific matters, in particular with regard to: 
• 
• 
• 

implementation of a robust control system to ensure the quality of the output and improvements in efficiency of procedures 
increase in the number of referrals in view of the effect of the Mediator case in France  
increase in the number of safety referrals, as a result of the revised legislative proposals from the European Commission for art. 107i procedures which 
foresee in a widening of the scope. 

To prepare the replies to the increasing number of requests for access to documents relating to referral procedures, mainly in relation to the identification of 
documents concerned and identification of content to be redacted in each document. This has become a permanent task in 2011, not only because of the number 
of requests, but also the amount/size of documents being requested (i.e. clinical trials reports) and because of the high public impact of the procedures. 

Access to documents 
Request 
Pages released 
Hours spent by Section 

2009 
Not tracked 
Not tracked 
Not tracked 

2010 
16 
1,421 
- 

2011 
38 
15,325 
> 800h 

2012 est. 
40 
16,000 
> 800h 

2013 est. 
42 
18,000 
> 900h 

1 

AD5 

To provide regulatory and procedural advice in relation to the high and increasing number of core activities for products and projects where an increase in the 
range and complexity of the procedures and project involvement is seen, in particular for the quality of opinions exercise, the increasing number of referrals 
where a high level of regulatory support needs to be provided. 

1 

AD8 

To support procedural work related to the coordination of mainly GCP inspections. 
Number of inspections 
GCP 
PhV 
GLP 

2009 
58 
- 
0 

2010 
62 
5 
4 

2011 
64 
9 
2 

2012 est. 
65 
9 
2 

2013 est. 
70 
10 
5 

EN 

15 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Unit 

2012 
Total 
Posts 

Posts requested 

Post Justifications 

To improve triggering of GCP inspections, in particular in relation to clinical trials conducted in third countries but also based on better evaluation of inspection 
intelligence and of information received from applicants in the application dossier.  
• 
• 
• 
• 

To improve follow-up of serious inspection findings with CHMP and with NCAs/inspectors and to the sponsor/applicant. 
To contribute to maintenance of information in scientific memory and corporate GXP inspection findings database. 
To contribute to capacity building for inspectors. 
To support potential use of penalties regulation in relation to PhV inspection findings. 

1 

AST1  To address the following tasks:  

• 

• 

• 

Potential increase of PD notifications due to new parallel distributors: there is a significant increase in the number of new parallel distributors submitting 
notifications to the Agency (20 in 2011) due to the process improvements. Even though that the "traditional" parallel distributors are submitting a similar 
number of notifications, it is expected that the new ones will increase the figures around 10-15% in 2013.  
Annual update for PD: there are currently no fees for notifications of a change. A new procedure involving an annual update with a "Do&Tell" system will 
be introduced in 2013 with a fee. Every annual update will be more complex and will attract a fee (currently changes don't attract fees) 
Increased workload in financial transactions: due to the above points it is necessary for the high level of business and financial transactions of the Sector 
and integration of the business and financial systems to reduce or where possible eliminate manual transactions and reprocessing of information. 

PD (initial notifications) 
Certificate 

2009 
2,247 
2,144 

2010 
2,599 
2,396 

2011 
2,551 
3,104 

2012 est. 
2,600 
3,200 

2013 est. 
2,800 
3,400 

The increased workload in both PD and Certificates and the potential new fees (i.e. Annual update for PD and Urgent Certificates) will multiply by 2 the financial 
transactions. However, the estimated revenue for both activities in 2013 compared with 2010 will be: 
• 
• 
Total in 2013=10M Euros (vs 6.6M in 2010, 50% increase) 

PD: 2010 (5.4M Euros). 2013 (7.8M Euros) 
Certificates: 2010 (1.2M Euros). 2013 (2.2M Euros) 

1 

AD5 

Cooperation in the coordination of inspections in third countries (Art. 111.1). Due to the continuing increase in globalisation of manufacturing and its departure 
from EU to third countries such as Singapore, Malaysia, Indonesia, Korea, India and China (and others can be expected to increase such as Brazil, and perhaps 
Russia) there will be a greater need for EU inspection of non-EU manufacturing sites. There is also a strong need to ensure best use of available inspection 
resource in the Community, to avoid duplication and to improve risk based selection and prioritisation of inspection targets. The EU Regulatory Network seeks 
the assistance of EMA in achieving this. 

H 

184 

6 

2 

AD5 

Two scientific administrators  

• 

For increased complexity and number of procedures, including IMI-related activities and biomarker qualification  

Scientific advice and protocol assistance requests 

2009 
388 

2010 
400 

2011 
433 

2012 est. 
493 

2013 est. 
543 

2 

AD5 

Two scientific administrators 
• 

For increase in maintenance procedures and clinical/non-clinical post-authorisation activities. 

EN 

16 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Unit 

2012 
Total 
Posts 

Posts requested 

Post Justifications 

• 
• 
• 

For increasing number of PSUR assessments  
Change in compilation, format, submission and assessment of PSURs and increased CHMP-PRAC interactions  
Qualitative and quantitative increase in workload related to variation procedures following the entry into force of Variations Regulation (EC) No 1234/2008 

CAPs (maintenance) 

Type IB (C/NC) 

Type II (C/NC) 

2009 
442 

- 

708 

2010 
520 

233 

618 

2011 
569 

235 

530 

2012 est. 
640 

2013 est. 
730 

337 

522 

387 

522 

One assistant  
• 

1 

AST1 

1 

AD8 

• 

• 

For coordination of maintenance procedures (e.g. Article 61(3) notifications, transfer of MAs, etc) and support to clinical/non-clinical post-authorisation 
activities (29% increase in CAPs from 2009 to 2011). 
For increased capacity of procedures management to transfer administrative workload from AD to AST staff 

CAPS (maintenance) 

2009 
442 

2010 
520 

2011 
569 

2012 est. 
649 

2013 est. 
730 

One experienced scientific administrator  
• 

Activities to strengthen the scientific secretariat and to support the committees (CHMP, CAT, PDCO, SAWP) in the field of biostatistics and methodology 
in the context of clinical trials for initial marketing authorisation applications, post-authorisation extensions, and paediatric procedures  
Peer review of biostatistical aspects in assessment reports; pilot activity for assessment of raw biostatistical data 

New initial MAAs 

2009 
96 

2010 
91 

2011 
100 

2012 est. 
112 

2013 est. 
112 

V 

61 

3 

1 

AD6 

One Scientific Administrator will be required due to the increased number of requests for scientific advice (ca. 150% increase since 2009), requests for MUMS 
classification, higher demands to support increasing numbers of initial applications from SME companies or for MUMS products.  

To be able to cope with the increasing number of applications for new technology products, which are expected in the areas cell and tissue products, 
nanotechnology medicinal products also for veterinary applications, other innovative products are certain immunologicals developed for food-producing animals, 
it is considered necessary to recruit one scientific administrator with experience in dealing with such new technology products. 
2012 est. 
26 
24 
12 
327 
12 (tbc) 

Scientific Advice 
MUMS/Limited markets classification 
Initial Applications 
Type I/II 
Referrals submitted (of which class referrals) 

2013 est. 
26 
(tbc) 
14 
tbc 
14 (tbc) 

2011 
26 
21 
11 
282 
12 (3) 

2010 
21 
23 
18 
150 
12 (1) 

2009 
11 
8** 
15 
113 
9 (4) 

EN 

17 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Unit 

2012 
Total 
Posts 

Posts requested 

1 

AD5 

Post Justifications 

One Scientific Administrator for providing input regarding safety issues (Part 3, consumer safety – withdrawal periods, user safety, environmental safety and 
resistance development of antimicrobials) for applications related to: scientific advice, marketing authorisation and referrals (the majority of referrals relate to 
safety issues).  

Full MRL applications 
Extensions/Modifications 
Extrapolations 

2009 
4 
2 
0 

2010 
4 
4 
2 

2011 
1 
7 
5 

2012 est. 
3 
4 
2 

2013 est. 
2 
4 
4 

Moreover, the workload in this area is also related to increasing demand on providing technical input and advice for the EU in international fora in particular 
Codex Alimentarius, and due to increasing demand for MRL reviews/extensions for old substances to adjust to modern requirements for residue control and 
international trade. 
Financial initiating agent and workflow manager, to support the volume of registration and distribution of incoming electronic applications registration 
distribution and financial initiation activities. Integration of processes into SIAMED and SAP. 

1 

AST1 

Scientific Advice and Protocol Assistance 
Initial evaluation + Line extensions 
Re-registration of ATMPs 
Variations 
Arbitration, Referrals and Opinions on scientific matters 
Transfers 
Renewals 
Scientific Services (incl. PMF, VAMF & ATMP 
certification; excl. Art. 58 opinions) 
Annual Fees 

2009 
365 
124 
0 
2227 
43 
20 
58 

26 
431 

2010 
409 
116 
2 
2598 
46 
20 
61 

32 
520 

2011 
433 
131 
6 
5008 
28 
26 
67 

33 
570 

2012 est. 
493 
132 
2 
4920 
50 
15 
48 

27 
650 

2013 est. 
543 
134 
tbc 
5170 
52 
10 
46 

28 
731 

A 

86 

2 

1 

AD5 

The Budget Section deals with the establishment and monitoring of the Agency’s long- and short-term budgets as well as project budgets; activity based 
budgeting and costing and the coordination of financial transactions and support to of financial actors throughout the Agency. 
- 

Strengthening  the  financial  planning,  reporting  and  control  environment  within  the  Agency  will  require  the  Budget  section  to  play  an  increasingly  pro-
active role in working in partnership with the operational units in the effective, efficient and economic management of our financial resources. The potential 
savings generated by these activities is difficult to quantify in advance but will far outweigh the cost of ensuring the Budget section is properly resourced to 
provide this service effectively. 

-  With the implementation of various pieces of pharmaceutical legislation the EMA Fee Regulation and its Implementing Rules need continuous monitoring 

and revision to ensure the financing of the Agency. 

-  With the implementation of SAP_FIN maintenance business support is required. Therefore in 2012 one post was dedicated to this task with the effect that 

the Budget section is unable to progress with important initiatives, such as Activity Based Costing, within existing resources. 

Budget (EUR‘000) 

2009 
194 389 

2010 
208 387 

2011 
208 863 

2012 est. 
222 489 

2013 est. 
240 316 

1 

AST3 

Increased workload in recruitment and Personnel Administration due to staff increases and changes in procedures. 
One AST is required to: 

EN 

18 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Unit 

2012 
Total 
Posts 

Posts requested 

Post Justifications 

• 

• 

• 

Handle workload for family allowance processing, performance/probation report administration and contract agent examinations. The larger number of TA 
and CA staff increases administrative workload in Personnel. 
Probation Reports: EMA is planning to introduce a Long-term Contract Agency Policy, foreseeing that every long-term Contract Agent will have to absolve 
a probation period, and this will affect the number of probation reports in 2012 and 2013 in addition. 
In 
following:.  
Personnel  Administrator, 
- Increase in difficult staff cases, problematic performance management staff cases and need to closely support managers. (10 such cases in 2011 all very 
time consuming) 
- Follow up for Art 16 issues for separated staff and subsequent employment linked to conflict of interests. 
- Secretary to Joint Committee for Art 16 and Disciplinary Committee. 

of  workload 

as  Assistant 

required 

increase 

addition 

due 

the 

the 

to 

to 

2 

Nursery Allowance 
Education allowance applications (B+C) 
Education contribution payments 
PER + 360° reports 
Probation reports 
CA testing procedures 

2009 
64 
210 
276 
186 
109 
48 

2010 
89 
180 
323 
234 
116 
47 

2011 
100 
200 
357 
261 
75 
70 

2012 est. 
120 
230 
440 
380 
90 
85 

2013 est. 
140 
250 
480 
450 
120 
95 

D 

38 

2 

1 

AD5 

1 

AD6 

I 

60 

2 

2 

AD5 

new responsibilities assigned by various new pieces of legislation.  
likely increase in litigation in the core business and in the field of transparency/ access to documents, and procurement and contracts.  
implementation of the penalties regulation which assigns the task to conduct investigation. 

A lawyer to address: 
• 
• 
• 
A Press Officer is needed to support crisis communication activities; including crisis communication plans and coordination with the European medicines 
network, drafting relevant communication material, and responding to queries from journalists and other stakeholders in writing and orally, coordination of 
interviews and press briefings. The post will carry out new tasks: increased volume of safety communications (more referrals, more safety information on 
nationally authorised products), support to national authorities with rapid communication and coordinating safety announcement, etc. 
As projects for the development of new information systems are completed, the information systems must be quality and performance tested then operated, 
maintained and supported. 2 AD posts are required: 
1 AD to provide support for an increasing number of applications, in particular with regards to: 

SIAMED II, Since SIAMED II will be finalised, the development team could be dismantled, requiring new skills from the support team (Flex3) 

• 
• 
• 
• 
• 

Central Repository 
eAF 
eudraGMP 4 
Eudralink 
Records Management 

1 AD as 15 Applications to be added in the portfolio of tested applications 

The tables below show a number of key workload metrics. It should be noted that the requested increases in staff numbers would help reduce the risk of 

EN 

19 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Unit 

2012 
Total 
Posts 

Posts requested 

dependency on external contractors whilst also saving money.  

Post Justifications 

New Application Releases 

Maintenance releases 

“green light” requests 

Internal users 

External users 

CAST analyses 

functional tests 

Performance tests 

2009 
N/A* 

N/A* 

N/A* 

845 

17000 

N/A* 

5* 

1* 

2010 
12 

79 

91 

850 

2011 
11 

89 

100 

900 

2012 est. 
10 

2013 est. 
8 

100 

110 

923 

112 

120 

946 

19,000 

22,000 

25,000 

29,000 

17 

41 

37 

18 

42 

44 

22 

50 

49 

25 

60 

55 

INFRA Tickets (user support) 
* These figures are either not available or reflect Q4 2009 only as these started to be captured, by the relevant sections, following the Agency’s organisation re-structure effective 
from Sept-2009; 
** Only collected from 1-March-2009 

13236** 

92,000 

79,000 

87,000 

82,425 

EN 

20 

EN 

 
  
 
 
 
 
 
 
4. 

Staffing forecasts 

Staffing forecasts are as follows : 

2013 

2012 

Posts 

Function group and grade 

Authorised under the Union budget 

Actually filled as at 31 December 
2011 

Authorised under the Union budget17 

 Permanent 

 Temporary 

 Permanent 

 Temporary 

 Permanent 

 Temporary 

AD 16  

AD 15  

AD 14  

AD 13  

AD 12  

AD 11  

AD 10  

AD 9  

AD 8  

AD 7  

AD 6  

AD 5  

AST 11  

AST 10  

AST 9  

AST 8  

AST 7  

AST 6  

AST 5  

AST 4  

AST 3  

AST 2  

AST 1  

AD total   

AST total   

Grand total   

Total staff 

4 

6 

8 

38 

38 

36 

40 

47 

45 

42 

42 

346 

2 

5 

7 

13 

20 

33 

35 

51 

39 

40 

20 

265 

611 

1 

4 

5 

7 

36 

35 

30 

37 

43 

39 

35 

32 

304 

2 

4 

8 

13 

19 

34 

34 

48 

32 

37 

16 

247 

551 

1 

4 

6 

7 

36 

36 

32 

38 

46 

49 

36 

35 

326 

2 

5 

7 

13 

20 

34 

35 

51 

39 

40 

18 

264 

590 

611 

551 

590 

17 

The Establishment plan 2012 has been revised as allowed by the Art.32 of the Commission Regulation 
2343/2002 of 19 November 2002 and the actual establishment plan for 2012 consists of 329 AD and 
261 AST. The distribution between the new AD and AST grades is related to the actual establishment 
plan of the agency which takes into account the 10% flexibility rule. 

EN 

21 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Grade 

AD8 

AD6 

AD5 

Total AD 

AST3 

AST1 

Total AST 

Overall Total 

New posts (per grade) 

Perm 

Temp - LT 

Temp - ST 

0 

0 

0 

0 

0 

0 

0 

0 

2 

3 

12 

17 

1 

3 

4 

21 

0 

0 

0 

EN 

22 

   EN