Proposal for a Council Regulation amending Regulation (EC) No 297/95 on fees payable to the European Medicines Agency  {SEC(2005) 407}
Date: 2005-03-31
Institutions: European Commission
Subjects: European organisation, marketing standard, medicinal product, payment, pharmaceutical legislation, veterinary medicinal product

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 31.03.2005 
COM(2005) 106 final 

2005/0023 (CNS) 

Proposal for a 

COUNCIL REGULATION 

amending Regulation (EC) No 297/95 on fees payable 
to the European Medicines Agency 

(presented by the Commission) 

{SEC(2005) 407} 

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EXPLANATORY MEMORANDUM 

1. 

INTRODUCTION AND BACKGROUND 

The pharmaceutical legislation has recently been revised. In this context, Regulation 
(EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 
laying  down  Community  procedures  for 
the  authorisation,  supervision  and 
surveillance of medicinal products for human and veterinary use and establishing a 
European  Medicines  Agency1  (EMEA,  referred  to  as  “the  Agency”)  has  been 
adopted by the Council and the European Parliament. It repeals Regulation (EEC) No 
2309/93/EC. 

As laid down in Article 67(3) of the Regulation, the Agency's revenue shall consist 
of  a  contribution  from  the  Community  and  fees  paid  by  undertakings  for  obtaining 
and  maintaining  Community  marketing  authorisations  and  for  other  services 
provided by the Agency2. 

It is acknowledged that the current fee scheme, as laid down in Council Regulation 
(EC)  No  297/95  on  fees  payable  to  the  EMEA3,  does  neither  take  into  account  the 
new  tasks  of  the  Agency,  nor  the  modifications  of  existing  tasks  introduced  by  the 
revised legislation. It is therefore necessary to amend it. 

When  drafting  this  proposal,  the  Commission  has  asked  the  EMEA  to  provide 
extensive feedback based on the experience gained with the application of the current 
system. In addition, a public consultation was held in July-September 2004, so as to 
take  into  account  the  position  of  relevant  parties,  in  particular  the  pharmaceutical 
industry (see Section 2.4). 

2. 

JUSTIFICATION 

2.1. 

Objectives 

Three major objectives have been pursued by the Commission in its proposal:  

– 

– 

– 

To  adapt  the  existing  fee  scheme  to  the  revised  legislation  and  the  new 
responsibilities conferred to the Agency, taking in consideration the experience 
with the current system; 

To ensure proportionality between the amount of the fees and the nature of the 
service actually provided by the Agency; 

To alleviate the financial pressure put on applicants, without undermining the 
Agency’s ability to perform its tasks. 

1 
2 
3 

OJ L 136, 30.4.2004, p. 1. 
Regulation (EC) No 726/2004, Article 67(3). 
Council  Regulation  (EC)  No  297/95  of  10  February  1995,  OJ  L  035  15.2.1995  p.  1,  as  amended  by 
Council  Regulation  (EC)  No  2743/98  of  14  December  1998,  OJ  L  345  19.12.98  p.  3  and  by 
Commission Regulation (EC) No 494/2003 of 18 March 2003, OJ L 73 19.3.2003 p. 6. 

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2.2. 

Experience gained with the application of the current system 

The EMEA has provided the Commission with an in-depth analysis of the operation 
of  the  current  system4.  Forward-looking  perspectives,  such  as  the  consequences  of 
the EU enlargement or the impact of the revision of the pharmaceutical legislation, 
were also taken in consideration. This analysis has led to the broad conclusion that 
the  general  principles,  as  well  as  the  overall  structure  of  the  fees,  have  indeed 
enabled  the  Agency  to  fulfil  its  mission  since  1995;  they  should  therefore  be 
maintained. Nevertheless, a number of key issues still require further optimisation. 

Firstly, post-authorisation activities have taken an increasing part of the EMEA costs 
associated with the management of a medicinal product throughout its lifecycle. This 
is especially relevant for innovative medicines, which constitute the ‘core business’ 
of the Agency, and which often require special risk management strategies as well as 
tailor-made pharmacovigilance programmes. Such  costs  are not  adequately covered 
by the corresponding fees, like the annual fee. 

In  addition,  the  Agency’s  revenues  heavily  depend  on  the  payment  of  initial  fees 
related to new applications. Despite the introduction of the annual fee in 1998, such 
dependence  is  still  significant,  and  may  hamper  the  EMEA’s  capability  to  perform 
long-term, multi-annual tasks, by affecting its financial stability. 

In  the  field  of  veterinary  medicines,  experience  suggests  that  the  costs  of  service 
incurred for the evaluation of these products are of the same order of magnitude as 
those for medicinal products for human use. However, this has to be balanced with 
the  very  specific  nature  of  the  animal  health  market  and  the  related  issues.  Such 
specificity should be taken into account in the proposal. 

Finally, Council Regulation (EC) No 297/95, as amended, has given flexibility to the 
Management Board and to the Executive Director of the EMEA to adapt certain fees, 
under clearly-defined circumstances, to the particular situation of the application and 
the  related  product.  Likewise,  the  use  of  graduated  fees  has  also  enabled  to  better 
reflect  the  actual  level  of  scientific  input  and  service  provided.  In  the  light  of  the 
abovementioned  principle  of  proportionality,  such  flexibility  could  be  further 
extended to other types of fees. 

2.3. 

Impact of the revised pharmaceutical legislation 

The  revision  of  the  pharmaceutical  legislation  has  a  direct  impact  on  the  Agency’s 
mission  and  responsibilities.  Regulation  (EC)  No  726/2004  provides  for  new  tasks, 
as well as modifications of already-existing ones. 

Post-authorisation  activities  have  been  substantially  strengthened.  For  instance,  the 
Agency  has  to  record  the  status  of  marketing  authorisations  for  medicinal  products 
granted in accordance with Community procedures, by monitoring when and where 
products  are  actually  marketed  in  the  Member  States,  or  cease  to  be5.  Besides,  the 
maintenance  of  marketing  authorisation  dossiers  and  of  the  various  databases 

4 

5 

Report to the European Commission on financing the European Agency for the Evaluation of Medicinal 
Products, EMEA Management Board, March 2004. 
Regulation (EC) No 726/2004, Article 13(4) and 38(4). 

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provided for in the legislation has to be managed by the Agency6. Finally, the risk-
benefit balance of authorised medicinal products is subject to permanent follow-up7. 

Regulation  (EC)  No  726/2004  foresees  new  kinds  of  scientific  services  to  be 
provided  by  the  EMEA,  such  as  the  evaluation  of  traditional  herbal  medicinal 
products8,  or  the  assessment  of  applications  for  medicinal  products  intended 
exclusively  for  markets  outside  the  Community,  in  the  context  of  cooperation  with 
the World Health Organisation9. New types of fees have therefore to be created, not 
only  for  these  services  but  also  for  those  which  were  not  taken  into  account  in  the 
last  revision  of  Council  Regulation  (EC)  No  297/95,  like  the  consultation  on 
ancillary substances incorporated in medical devices10, or the certification of plasma 
master files and vaccine antigen master files11. 

New provisions in Regulation (EC) No 726/2004 on generics and similar biological 
medicinal products12 also call for the definition of related fees. In this respect, it is 
anticipated  that  the  average  cost  for  the  assessment  of  similar  biological  medicinal 
products, although lower than for a full, stand-alone dossier, will still be significantly 
higher than for a standard generic. 

Lastly, it is specified in the revised legislation that provisions shall be adopted by the 
Commission,  establishing  the  circumstances  in  which  small  and  medium-sized 
enterprises  (SMEs)  may  pay  reduced  fees,  defer  payment  of  the  fee,  or  receive 
administrative  assistance13.  Thus,  the  situation  of  SMEs  has  to  be  considered 
separately, i.e. outside the scope of the present proposal. 

2.4. 

Outside consultation 

Interested parties, in particular the pharmaceutical industry, have been consulted. In 
July  2004,  the  Commission  launched  an  external  consultation  on  its  draft  proposal, 
and  received  eight  contributions  from  industry  associations,  regulators,  and 
individual companies. Some of them, especially the ones from industry associations, 
were the result of wider, internal consultation. Contributions were carefully taken in 
consideration for the refinement of the Commission’s draft. 

The  vast  majority  of  respondents  welcomed  the  proposal,  the  opportunity  to 
comment,  and  explicitly  supported  the  outlined  objectives  and  key  principles.  In 
particular,  the  principle  of  proportionality  between  the  fees,  the  corresponding 
services, and the related costs, was strongly emphasised.  

6 
7 
8 
9 
10 
11 
12 
13 

Regulation (EC) No 726/2004, Article 57(1)d and 57(1)l. 
Regulation (EC) No 726/2004, Article 16(2) and 41(4). 
Regulation (EC) No 726/2004, Article 62(1). 
Regulation (EC) No 726/2004, Article 58. 
In accordance with Council Directive No 93/42/EEC, as amended. 
As defined in Directive No 2003/63/EC, Annex I, Part III, Sections 1.1 and 1.2. 
Directive 2001/83/EC as amended by Directive 2004/27/EC, Article 10(4). 
Regulation (EC) No 726/2004, Article 70(2). 

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3. 

PRESENTATION OF THE PROPOSAL 

A  comparison  of  the  current  fees  vs.  the  proposal,  including  references  to  the 
relevant Articles, is annexed to the Explanatory Memorandum. 

In view of the abovementioned considerations, the general structure of the fees and 
the underlying principles have not been changed. Moreover, given the increase that 
was  already  implemented  in  March  2003,  most  of  the  fees  have  been  kept  to  the 
same level, or slightly reduced. 

3.1. 

Annual fee 

As  mentioned  in  Section  2.2,  costs  related  to  post-authorisation  activities  are,  at 
present,  not  appropriately  covered.  If  no  action  is  taken,  this  discrepancy  could 
increase  with  the  entering  into  force  of  the  revised  legislation  and  the  new 
responsibilities of the Agency. While it is required by law that activities relating to 
pharmacovigilance and to market surveillance shall receive adequate public funding 
commensurate with the tasks conferred14, such funding alone may not be sufficient to 
fully cover administrative costs described in Section 2.3, e.g. maintaining up-to-date 
marketing  authorisation  dossiers  and  the  various  databases.  Besides,  the  EMEA’s 
financial  stability  is  affected  by  its  dependence  on  initial  fees  linked  to  new 
applications. For these reasons, it is hence proposed to increase the annual fee, both 
in the human and veterinary sectors, by 10%. 

3.2.  Medicinal products for human use 

Most of the fees for services related to medicinal products for human use have been 
kept to the same level. In addition to the annual fee increase (see Section 3.1), it is 
suggested: 

– 

– 

– 

to reduce the fee for generic  medicinal products, in order to better reflect the 
actual cost of the evaluation of the marketing authorisation application; 

to  harmonise  extension  fees,  Type  II  variation  fees,  and  fees  associated  with 
the submission of additional presentations of a given medicinal product; 

to  reduce  the  fee  for  Type  IA  variations,  so  as  to  better  reflect  the 
administrative nature of the service provided. 

3.3. 

Veterinary medicinal products 

Taking  into  account  the  specific  nature  of  the  animal  health  market  and  the 
commercial and regulatory environment in which the related companies evolve, it is 
proposed to keep all fees related to veterinary medicinal products to the same level, 
apart from the annual fee (see Section 3.1), and the fee for Type IA variations, which 
has been reduced for the reason outlined above. 

14 

Regulation (EC) No 726/2004, Article 67(4). 

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3.4. 

Scientific services 

New types of fees have been defined for a wide range of scientific services provided 
by the Agency. These are related to (see Section 2.3): 

– 

– 

– 

– 

opinions on traditional herbal medicinal products; 

assessment  of  applications  for  medicinal  products  intended  exclusively  for 
markets outside the Community, in the context of cooperation with the World 
Health Organisation. 

consultation  of  the  Committees  on  ancillary  substances,  including  blood 
derivatives, incorporated in medical devices; 

evaluation and certification of plasma master files and vaccine antigen master 
files; 

Experience acquired by the EMEA on these services has shown that they can lead to 
the mobilisation of significant scientific, administrative and financial resources. This 
is further reflected by the proposed levels of the fees. 

3.5. 

Other provisions 

As already laid down in Council Regulation (EC) No 297/95, substantial flexibility 
has been given to the Management Board and the Executive Director of the EMEA 
for the practical implementation of this Regulation. In particular, the option to draw-
up detailed lists of reduced fees for certain services, under well-defined conditions, 
has been extended to other fee categories. 

As  mentioned  in  Section  2.3,  a  specific  fee  has  been  defined  for  similar  biological 
medicinal  products.  The  calculation  of  the  fee  is  based  on  the  complex  nature  of 
these  medicines,  the  expected  costs  for  the  dossier  evaluation,  and  the  particular 
status of this emerging and fast-growing market. 

Regarding due date and belated payment, the time period within which fees shall be 
payable has been extended from 30 to 45 days. Moreover, a special deferral rule has 
been proposed for applications concerning medicines to be used in human pandemic 
situations (such as pandemic influenza vaccines). 

Finally, an indexation clause has been introduced, in order to easily adapt the fees to 
inflation variations. 

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(in Euros) 

Human
Full fee 

Reduced fee 

Extension fee 

Type I variation 

Type II variation 

Renewal 
Inspection 
Transfer 
Annual fee 
Referral 

Scientific advice 
Scientific services 
Administrative services 

Veterinary
Full fee 

Full fee vaccines 

Reduced fee 

Reduced fee vaccines 

EN 

base 
addit. strength/form 
addit. presentation 
base 

addit. strength/form 
addit. presentation 

new strength/form etc. 
new presentation 

base 
addit. strength/form 
addit. presentation 
vaccines 
addit. strength/form/pres. 
base 

addit. strength/form 
addit. presentation 
vaccines 
addit. strength/form/pres. 

Current

232000 
23200 
5800 
116000 

23200 
5800 

58000 
11600 
5800 

69600 

11600 
17400 
5800 
75600 
58000 

69600 

5800 

116000 
11600 
5800 
58000 
5800 
58000 

11600 
5800 
29000 
5800 

generic 
bio-similar 

max 

IA 
IB 
max 

max 

max 

max 
max 
max 

immunologicals 

generic 
bio-similar 

immunologicals 

7 

Proposal

232000 
23200 
5800 
90000 
150000 
9000 
5800 

69600 
5800 
2500 
5800 
69600 

11600 
17400 
5800 
83200 
58000 

69600 
232000 
5800 

116000 
11600 
5800 
58000 
5800 
58000 
98000 
11600 
5800 
29000 
5800 

Dif.

0% 
0% 
0% 
-22% 
NEW 
-61% 
0% 

20% 
-50% 
-57% 
0% 
0% 

0% 
0% 
0% 
10% 
0% 

0% 
NEW 
0% 

0% 
0% 
0% 
0% 
0% 
0% 
NEW 
0% 
0% 
0% 
0% 

Ref.

Art. 3(1)(a) 
Art. 3(1)(a) 
Art. 3(1)(a) 
Art. 3(1)(b) 
Art. 3(1)(b) 
Art. 3(1)(b) 
Art. 3(1)(b) 

Art. 3(1)(c) 
Art. 3(1)(c) 
Art. 3(2)(a) 
Art. 3(2)(a) 
Art. 3(2)(b) 

Art. 3(3) 
Art. 3(4) 
Art. 3(5) 
Art. 3(6) 
Art. 4 

Art. 8(1) 
Art. 8(2) 
Art. 8(3) 

Art. 5(1)(a) 
Art. 5(1)(a) 
Art. 5(1)(a) 
Art. 5(1)(a) 
Art. 5(1)(a) 
Art. 5(1)(b) 
Art. 5(1)(b) 
Art. 5(1)(b) 
Art. 5(1)(b) 
Art. 5(1)(b) 
Art. 5(1)(b) 

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Extension fee 

Type I variation 

Type II variation 

Renewal 
Inspection 
Transfer 
Annual fee 
Referral 
MRL fee 

Scientific Advice 
Scientific services 
Administrative services 

new strength/form etc. 
new presentation 
vaccines 

vaccines 

base 
amend/extend existing 
clinical trials 

29000 
5800 
5800 
5800 

34800 
5800 

5800 
17400 
5800 
25200 
34800 
58000 
17400 
17400 

34800 

5800 

max 

(vaccines 
IA 
IB 
max 

max 

max 

max 
max 
max 

29000 
5800 
5800 
2500 
5800 
34800 
5800 

5800 
17400 
5800 
27700 
34800 
58000 
17400 
17400 

34800 
116000 
5800 

0% 
0% 
0% 
-57% 
0% 
0% 
0% 

0% 
0% 
0% 
10% 
0% 
0% 
0% 
0% 

0% 
NEW 
0% 

Art. 5(1)c 
Art. 5(1)c 
Art. 5(1)c 
Art. 5(2)(a) 
Art. 5(2)(a) 
Art. 5(2)(b) 
Art. 5(2)(b) 

Art. 5(3) 
Art. 5(4) 
Art. 5(5) 
Art. 5(6) 
Art. 6 
Art. 7 
Art. 7 
Art. 7 

Art. 8(1) 
Art. 8(2) 
Art. 8(3) 

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2005/0023 (CNS) 

Proposal for a 

COUNCIL REGULATION 

amending Regulation (EC) No 297/95 on fees payable 
to the European Medicines Agency 

THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community,  

Having regard to Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to 
the European Agency for the Evaluation of Medicinal Products15, and in particular Article 12 
thereof, 

Having regard to the proposal from the Commission16, 

Having regard to the opinion of the European Parliament17, 

Whereas: 

(1) 

(2) 

15 

16 
17 
18 
19 

20 

Article 67(3) of Regulation (EC) No 726/2004 of the European Parliament and of the 
Council of 31 March 2004 laying down Community procedures for the authorisation, 
supervision and surveillance of medicinal products for human and veterinary use and 
establishing  a  European  Medicines  Agency18,  stipulates  that  the  revenue  of  the 
European Medicines Agency (hereinafter referred to as ‘the Agency’) shall consist of a 
contribution  from  the  Community  and  fees  paid  by  undertakings  for  obtaining  and 
maintaining  Community  marketing  authorisations  and  for  other  services  provided  by 
the Agency. 

Regulation  (EC)  No  726/2004  also  provides  for  new  tasks  for  the  Agency. 
Furthermore,  the  existing  tasks  have  also  been  changed  following  amendments  to 
the  Council  of 
Directive  2001/83/EC  of 
6 November 2001  on  the  Community  code  relating  to  medicinal  products  for  human 
use19, and to Directive 2001/82/EC of the European Parliament and of the Council of 
6 November 2001 on the Community code relating to veterinary medicinal products20. 

the  European  Parliament  and  of 

OJ  L  35,  15.2.1995,  p.  1.  Regulation  as  last  amended  by  Commission  Regulation  (EC)  No  494/2003 
(OJ L 73 19.3.2003 p. 6). 
OJ C , , p. . 
OJ C , , p. . 
OJ L 136, 30.4.2004, p. 1. 
OJ L 311, 28.11.2001, p. 67. Directive as last amended by Directive 2004/27/EC (OJ L 136, 30.4.2004, 
p. 34). 
OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive 2004/28/EC (OJ L 136, 30.4.2004, 
p. 58). 

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(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

In view of the experience gained since 1995, it is appropriate to maintain the general 
principles  and  overall  structure  of  the  fees,  as  well  as  the  main  operational  and 
procedural  provisions  established  by  Regulation  (EC)  No  297/95;  in  particular,  the 
calculation of the level of fees charged by the Agency should be based on the principle 
of the service actually provided and should be related to specific medicinal products. 
The  proportionality  between  the  fees  and  the  assessment  related  costs  of  each 
application, as well as the provision of the service requested, should also be ensured. 

Regulation  (EC)  No  726/2004  lays  down  provisions  for  new  post-authorisation 
activities  to  be  carried  out  by  the  Agency.  These  tasks  include  the  recording  of  the 
actual  marketing  of  medicinal  products  authorised  in  accordance  with  Community 
procedures,  the  maintenance  of  marketing  authorisation  dossiers  and  of  the  various 
databases  managed  by  the  Agency,  as  well  as  the  continuous  follow-up  of  the  risk-
benefit balance of authorised medicinal products. In addition, it is necessary to reduce 
the Agency’s dependence on fees related to new applications. The annual fee should 
therefore be increased by 10% to accommodate those changes. 

New categories of fees have to be created to cover new, specific tasks now provided 
by the Agency, such as new types of scientific opinions related to a medicinal product. 

The  Management  Board  of  the  Agency  should  be  competent  to  specify  provisions 
necessary  for  the  application  of  this  Regulation,  on  a  proposal  from  the  Executive 
Director and following a favourable opinion from the Commission. In particular, the 
Management  Board  should  establish,  for  certain  services  where  the  level  of  the 
corresponding  fee  is  set  as  a  maximum,  detailed  classifications  and  lists  of  reduced 
fees. 

The  Executive  Director  should  also  keep  the  competence  to  decide,  in  exceptional 
circumstances, on reductions of the fees, in particular as regards certain cases related 
to  specific  medicinal  products  and  where  a  reduction  is  necessary  for  imperative 
reasons of public or animal health. Likewise, the Executive Directive should have the 
possibility  to  decide  on  exemptions  from  the  obligation  to  pay  a  fee  in  the  case  of 
medicinal  products  for  the  treatment  of  rare  diseases,  for  the  treatment  of  diseases 
affecting minor animal species and for the addition of animal species in the case of the 
determination of maximum residue limits in accordance with the procedure laid down 
in Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community 
procedure  for  the  establishment  of  maximum  residue  limits  of  veterinary  medicinal 
products in foodstuffs of animal origin21.  

In accordance with Article 70(2) of Regulation (EC) No 726/2004, the circumstances 
under which small and medium-sized enterprises may pay reduced fees, defer payment 
of the fee or receive administrative assistance are not to be covered by this Regulation. 

In  order  to  allow  an  immediate  budgetisation,  the  fees  should  be  due  on  the  date  of 
validation but should be payable within a certain number of days. 

(10)  Provisions  should  be  laid  down  to  report  on  the  implementation  of  this  Regulation 
after experience has been gained and to review, if necessary, the level of the fees. 

21 

OJ L 224, 18.8.1990, p.1. Regulation as last amended by Commission Regulation (EC) No 1875/2004 
(OJ L 326, 29.10.2004, p. 19). 

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(11) 

It  is  appropriate  to  include  an  indexation  mechanism  for  automatically  adjusting  the 
fees in relation to official inflation rates indices. 

(12)  For the sake of consistency, this Regulation should apply at the same time as the full 
entering  into  force  of  Regulation  (EC)  No  726/2004.  It  should  not  apply  to  valid 
applications pending at the time of its application. 

(13)  Regulation (EC) No 297/95 should therefore be amended accordingly, 

HAS ADOPTED THIS REGULATION: 

Regulation (EC) No 297/95 is amended as follows: 

Article 1 

(1) 

(2) 

In the second paragraph of Article 1 “ecus” is replaced by “euros”. 

Article 3 is amended as follows: 

(a) 

In  the  title  “Regulation  (EEC)  No  2309/93”  is  replaced  by  “Regulation  (EC) 
No 726/2004 of the European Parliament and of the Council* 

______________________________________________________ 

* OJ L 136, 30.4.2004, p. 1”. 

(b)  Paragraph 1 is amended as follows: 

(i) 

Point (a) is amended as follows: 

– 

The first subparagraph is replaced by the following: 

“A  full  fee  of  EUR  232  000  shall  apply  for  an  application  for  a 
marketing authorisation supported by a full dossier. That fee shall 
cover  a  single  strength  associated  with  one  pharmaceutical  form 
and one presentation.” 

– 

The second sentence of the second subparagraph is replaced by the 
following: 

increase 

“That 
shall 
pharmaceutical form and one presentation.” 

cover  one 

additional 

strength  or 

(ii)  Points (b) and (c) are replaced by the following: 

“(b)  Reduced fee 

A  reduced  fee  of  EUR  90  000  shall  apply  to  applications  for  a 
marketing  authorisation  pursuant  to  Articles  10(1),  10(3)  and  10c 
of  Directive  2001/83/EC  of  the  European  Parliament  and  of  the 
Council**.  That  fee  shall  cover  a  single  strength  associated  with 

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one pharmaceutical form and one presentation.   

A specific reduced fee of EUR 150 000 shall apply to applications 
for a marketing authorisation pursuant to Article 10(4) of Directive 
2001/83/EC. That fee shall cover a single strength associated with 
one pharmaceutical form and one presentation.   

The  reduced  fees  referred  to  in  the  first  and  second  subparagraph 
shall  be  increased  by  EUR  9  000  for  each  additional  strength  or 
pharmaceutical  form  submitted  at  the  same  time  as  the  initial 
application  for  authorisation.  That  increase  shall  cover  one 
additional  strength  or  pharmaceutical  form  and  one  presentation. 

The  reduced  fees  referred  to  in  the  first  and  second  subparagraph 
shall be increased by EUR 5 800 for each additional presentation of 
the same strength and pharmaceutical form, submitted at the same 
time as the initial application for authorisation. 

(c)  Extension fee 

An extension fee of EUR 69 600 shall apply for each extension of a 
marketing  authorisation  within  the  meaning  of  Annex  II  to 
Commission Regulation (EC) No 1085/2003***, which has already 
been granted. 

A reduced extension fee falling within the range of EUR 17 400 to 
EUR  52  200  shall  apply  for  certain  extensions.  Those  extensions 
shall be included in a list, which shall be drawn up in accordance 
with Article 11(2). 

The extension fee and the reduced extension fee shall be increased 
by  EUR  5  800  for  each  additional  presentation  of  the  same 
extension submitted at the time of the extension application. 

_______________________________________________________ 

** OJ L 311, 28.11.2001, p. 67. 

*** OJ L 159, 27.06.2003, p. 24.” 

(c)  Paragraph 2 is amended as follows: 

(i) 

In  point  (a)  the  first  subparagraph  is  replaced  by  the  following:  

“A Type I variation fee shall apply for a minor variation to a marketing 
authorisation,  as  defined  in  Article  3(2)  of  Regulation  (EC)  No 
1085/2003. For Type IA variations, the fee shall be EUR 2 500. For Type 
IB variations, the fee shall be EUR 5 800.” 

(ii) 

In point (b) the first subparagraph is replaced by the following: 

EN 

12 

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“A Type II variation fee of EUR 69 600 shall apply for a major variation 
to  a  marketing  authorisation,  as  defined  in  Article  3(3)  of  Regulation 
(EC) No 1085/2003. 

A reduced Type II variation fee falling within the range of EUR 17 400 
to EUR 52 200 shall apply for certain variations. Those variations shall 
be included in a list, which shall be drawn up in accordance with Article 
11(2).” 

(d) 

In paragraph 4 the following subparagraph is added:  

“The  inspection  fee  shall  differ  according  to  the  extent  and  nature  of  the 
inspection  and  on  the  basis  of  the  conditions  laid  down  in  accordance  with 
Article 11(2).”  

(e)  Paragraph 6 is replaced by the following: 

“6. Annual fee  

An annual fee of EUR 83 200 shall apply for each marketing authorisation of a 
medicinal product. That fee shall cover all authorised presentations of a given 
medicinal product. 

A reduced annual fee falling within the range of EUR 20 800 to EUR 62 400 
shall apply for certain types of medicinal products. Those medicinal products 
shall be included in a list, which shall be drawn up in accordance with Article 
11(2).” 

(3) 

Article 4 is replaced by the following: 

“Article 4 

Medicinal  products  for  human  use  covered  by  the  procedures  laid  down  in 
Directive 2001/83/EC 

Referral fee 

A referral fee of EUR 58 000 shall apply where the procedures laid down in Articles 
30(1)  and  31  of  Directive  2001/83/EC  are  initiated by the applicant of a marketing 
authorisation or the holder of an existing marketing authorisation. 

Where  more  than  one  applicant  of  marketing  authorisations  or  holder  of  existing 
marketing  authorisations  are  concerned  by  the  procedures  referred  to  in  the  first 
subparagraph,  the  applicants  or  holders  may  be  grouped  for  the  purpose  of  the 
payment  of  one  single  referral  fee.  If  however,  the  same  procedure  concerns  more 
than 10 different applicants or holders, the fee will be charged by the application of a 
flat-rate fee.” 

EN 

13 

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(4) 

Article 5 is amended as follows: 

(a) 

In  the  title  “Regulation  (EEC)  No  2309/93”  is  replaced  by  “Regulation  (EC) 
No 726/2004”. 

(b)  Paragraph 1 is amended as follows: 

(i) 

Point (a) is amended as follows: 

– 

The first subparagraph is replaced by the following: 

“A  full  fee  of  EUR  116  000  shall  apply  for  an  application  for  a 
marketing authorisation supported by a full dossier. That fee shall 
cover  a  single  strength  associated  with  one  pharmaceutical  form 
and one presentation.” 

– 

The second sentence of the second subparagraph is replaced by the 
following:  

increase 

shall 
“That 
pharmaceutical form and one presentation.” 

cover  one 

additional 

strength  or 

– 

the 

In 
“immunological veterinary medicinal products”. 

subparagraph,  “vaccines” 

fourth 

is 

replaced  by 

(ii)  Point (b) is replaced by the following: 

“A reduced fee of EUR 58 000 shall apply to applications for a marketing 
authorisation  pursuant  to  Articles  13(1),  13(3)  and  13c  of  Directive 
2001/82/EC of the European Parliament and of the Council****. That fee 
shall cover a single strength associated with one pharmaceutical form and 
one presentation. 

A  specific  reduced  fee  of  EUR  98  000  shall  apply  to  applications  for  a 
to  Article  13(4)  of  Directive 
marketing  authorisation  pursuant 
2001/82/EC.  That  fee  shall  cover  a  single  strength  associated  with  one 
pharmaceutical form and one presentation. 

The reduced fees referred to in the first and second subparagraph shall be 
increased by EUR 11 600 for each additional strength or pharmaceutical 
form  submitted  at  the  same  time  as  the  initial  application  for 
authorisation.  That  increase  shall  cover  one  additional  strength  or 
pharmaceutical form and one presentation. 

The reduced fees referred to in the first and second subparagraph shall be 
increased  by  EUR  5  800  for  each  additional  presentation  of  the  same 
strength  and  pharmaceutical  form,  submitted  at  the  same  time  as  the 
initial application for authorisation. 

In the case of immunological veterinary medicinal products, the fee shall 

EN 

14 

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be  reduced  to  EUR  29  000,  with  each  additional  strength  and/or 
pharmaceutical  form  and/or  presentation  entailing  an  increase  of  EUR 
5 800. 

For  the  purposes  of  this  point  (b),  the  number  of  target  species  is 
irrelevant. 

**** OJ L 311, 28.11.2001, p. 1.” 

(iii)  Point (c) is replaced by the following:   

“(c) 

Extension fee   

An  extension  fee  of  EUR  29  000  shall  apply  for  each  extension  of  a 
marketing  authorisation  within  the  meaning  of  Annex  II  to  Regulation 
(EC) No 1085/2003, which has already been granted.   

A reduced extension fee falling within the range of EUR 7 200 to EUR 
21  700  shall  apply  for  certain  extensions.  Those  extensions  shall  be 
included  in  a  list,  which  shall  be  drawn  up  in  accordance  with  Article 
11(2). 

The  extension  fee  and  the  reduced  extension  fee  shall  be  increased  by 
EUR  5  800  for  each  additional  presentation  of  the  same  extension 
submitted at the time of the extension application.” 

(c)  Paragraph 2 is amended as follows: 

(i) 

In  point  (a)  the  first  subparagraph  is  replaced  by  the  following: 

“A Type I variation fee shall apply for a minor variation to a marketing 
authorisation, as defined in Article 3(2) of Commission Regulation (EC) 
No 1085/2003. For Type IA variations, the fee shall be EUR 2 500. For 
Type IB variations, the fee shall be EUR 5 800.” 

(ii)  Point (b) is replaced by the following:   

“A Type II variation fee of EUR 34 800 shall apply for a major variation 
to  a  marketing  authorisation,  as  defined  in  Article  3(3)  of  Regulation 
(EC) No 1085/2003. 

A reduced Type II variation fee falling within the range of EUR 8 700 to 
EUR 26 100 shall apply for certain variations. Those variations shall be 
included  in  a  list,  which  shall  be  drawn  up  in  accordance  with  Article 
11(2). 

In the case of immunological veterinary medicinal products, the fee shall 
be EUR 5 800. 

In the event of the same variation being introduced, the fee referred to in 

EN 

15 

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the  first,  second  and  third  subparagraph  shall  cover  all  authorised 
strengths, pharmaceutical forms and presentations.” 

(d) 

In paragraph 4 the following subparagraph is added:  

“The  inspection  fee  shall  differ  according  to  the  extent  and  nature  of  the 
inspection  and  on  the  basis  of  the  conditions  laid  down  in  accordance  with 
Article 11(2).” 

(e)  Paragraph 6 is replaced by the following: 

“6. Annual fee  

An annual fee of EUR 27 700 shall apply for each marketing authorisation of a 
medicinal product. That fee shall cover all authorised presentations of a given 
medicinal product. 

A  reduced  annual  fee  falling  within  the  range  of  EUR  6  900  to  EUR  20  800 
shall apply for certain types of medicinal products. Those medicinal products 
shall be included in a list, which shall be drawn up in accordance with Article 
11(2).” 

(5) 

Article 6 is replaced by the following: 

“Article 6 

Veterinary  medicinal  products  covered  by  the  procedures  laid  down  in 
Directive 2001/82/EC 

Referral fee 

A referral fee of EUR 34 800 shall apply where the procedures laid down in Articles 
34(1)  and  35  of  Directive  2001/82/EC  are  initiated by the applicant of a marketing 
authorisation or the holder of an existing marketing authorisation. 

Where  more  than  one  applicant  of  marketing  authorisations  or  holder  of  existing 
marketing  authorisations  are  concerned  by  the  procedures  referred  to  in  the  first 
subparagraph,  the  applicants  or  holders  may  be  grouped  for  the  purpose  of  the 
payment  of  one  single  referral  fee.  If  however,  the  same  procedure  concerns  more 
than 10 different applicants or holders, the fee will be charged by the application of a 
flat-rate fee.” 

(6) 

Article 7 is amended as follows: 

(a) 

In the title, “for veterinary medicinal products” is replaced by “for veterinary 
medicinal  products  in  accordance  with  the  procedures  laid  down  in  Council 
Regulation (EEC) No 2377/90***** 

*****OJ L 224, 18.8.1990, p. 1.” 

EN 

16 

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(b) 

In paragraph 1 the second subparagraph is replaced by the following: 

“An additional fee of EUR 17 400 shall apply for each application to modify an 
existing  MRL,  as  included  in  one  of  the  Annexes  to  Regulation  (EEC)  No 
2377/90.” 

(c)  Paragraph 2 is deleted. 

(7) 

Article 8 is replaced by the following: 

“Article 8 

Various Fees 

1. Fee for scientific advice 

The  scientific  advice  fee  shall  apply  where  an  application  is  made  for  scientific 
advice concerning the conduct of the various tests and trials necessary to demonstrate 
the quality, safety and efficacy of medicinal products. 

When it concerns medicinal products for human use, the fee shall be EUR 69 600. 

When it concerns veterinary medicinal products, the fee shall be EUR 34 800. 

A  reduced  scientific  advice  fee  falling  within  the  range  of  EUR  17  400  to  EUR 
52 200  shall  apply  for  certain  scientific  advice  concerning  medicinal  products  for 
human use. 

A reduced scientific advice fee falling within the range of EUR 8 700 to EUR 26 100 
shall apply for certain scientific advice concerning veterinary medicinal products. 

The  scientific  advice  referred  to  in  the  fourth  and  fifth  subparagraph  shall  be 
included in a list, which shall be drawn up in accordance with Article 11(2). 

2. Fee for scientific services not covered by Articles 3 to 7 or by Article 8(1) 

A  scientific  service  fee  shall  apply  where  an  application  is  made  for  any  scientific 
advice or opinion by a scientific Committee, which is not covered by Articles 3 to 7 
or  by  Article  8(1).  This  includes  any  evaluation  of  traditional  herbal  medicinal 
products, any opinion on medicinal products for compassionate use, any consultation 
on ancillary substances, including blood derivatives, incorporated in medical devices, 
and any evaluation of plasma master files and vaccine antigen master files. 

When it concerns medicinal products for human use, the fee shall be EUR 232 000. 

When it concerns veterinary medicinal products, the fee shall be EUR 116 000. 

The provisions of Article 3 shall apply to any scientific opinion for the evaluation of 
medicinal  products  for  human  use  intended  exclusively  for  markets  outside  the 
Community pursuant to Article 58 of Regulation (EC) No 726/2004. 

EN 

17 

   EN 

 
 
 
A  reduced  scientific  service  fee  falling  within  the  range  of  EUR  2  500  to  EUR 
200 000 shall apply for certain scientific opinions or services concerning medicinal 
products for human use. 

A  reduced  scientific  service  fee  falling  within  the  range  of  EUR  2  500  to  EUR 
100 000 shall apply for certain scientific opinions or services concerning veterinary 
medicinal products. 

The  scientific  opinions  or  services  referred  to  in  the  fifth  and  sixth  subparagraph 
shall be included in a list, which shall be drawn up in accordance with Article 11(2). 

3. Fee for administrative services 

A  fee  falling  within  the  range  of  EUR  100  to  EUR  5  800  shall  apply  for 
administrative  services  where  documents  or  certificates  are  issued  outside  the 
framework  of  services  covered  by  another  fee  provided  for  in  this  Regulation  or 
where  an  application  is  rejected  following  the  conclusion  of  the  administrative 
validation  of  the  related  dossier  or  where  the  information  required  in  the  case  of 
parallel distribution has to be checked.  

A  classification  of  the  services  and  fees  shall  be  included  in  a  list,  which  shall  be 
drawn up in accordance with Article 11(2).” 

(8) 

In Article 9 the second paragraph is replaced by the following: 

“A total or partial exemption from payment of the fees laid down in this Regulation 
may  be  granted,  in  particular  for  medicinal  products  for  treating  rare  diseases  or 
diseases  affecting  minor  animal  species  or  for  extension  of  existing  MRL  to 
additional animal species or for medicinal products available for compassionate use. 

The detailed conditions for the application of the total or partial exemption shall be 
determined in accordance with Article 11(2). 

The fee payable for an opinion on a medicinal product for compassionate use shall be 
deduced from the fee payable for an application for a marketing authorisation of the 
same medicinal product, where such application is submitted by the same applicant.” 

(9) 

Article 10 is replaced by the following: 

“Article 10 

Due date and deferral of the payment 

1.  Fees  shall  be  due  on  the  date  of  the  administrative  validation  of  the  relevant 
application  unless  specific  provisions  stipulate  otherwise.  They  shall  be  payable 
within 45 days of the date of the notification of the administrative validation to the 
applicant. They shall be paid in Euros. 

The  annual  fee  shall  be  due  on  the  first  and  each  subsequent  anniversary  of  the 
notification  of  the  marketing  authorisation  decision.  It  shall  be  payable  within  45 
days of the due date. The annual fee shall relate to the preceding year. 

EN 

18 

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The  inspection  fee  shall  be  payable  within  45  days  from  the  date  on  which  the 
inspection is carried out. 

2.  The  payment  of  the  fee  for  an  application  for  a  marketing  authorisation  of  a 
medicinal product to be used in a human pandemic situation shall be deferred until 
the pandemic situation is duly recognised, either by the World Health Organisation 
or  by  the  Community  in  the  framework  of  Decision  2119/98/EC  of  the  European 
Parliament and of the Council******. Such deferral shall not exceed five years. 

3. Where any fee payable under this Regulation remains unpaid at its due date and 
without  prejudice  to  the  Agency’s  capacity  to  institute  legal  proceedings  conferred 
on  it  by  Article  71  of  Regulation  (EC)  No  726/2004,  the  Executive  Director  may 
decide  not  to  provide  the  requested  services  or  to  suspend  all  the  services  and 
procedures under way until the fee has been paid, including the relevant interest as 
provided  for  in  Article  86  of  Commission  Regulation  (EC,  Euratom)  No 
2342/2002*******. 

****** OJ L 268, 3.10.1998, p.1. 

******* OJ L 357, 31.12.2002, p.1.” 

(10) 

In Article 11 paragraph 2 is replaced by the following: 

“2.  Without  prejudice  to  the  provisions  of  Regulation  (EC)  No  726/2004,  the 
Management Board of the Agency may, on a proposal from the Executive Director 
and  following  a  favourable  opinion  from  the  Commission,  specify  any  provision 
necessary for the application of this Regulation.” 

(11) 

Article 12 is amended as follows: 

(a) 

In  the  second  paragraph,  “Article  73  of  Regulation  (EEC)  No  2309/93”  is 
replaced by “Article 87(2) of Regulation (EC) No 726/2004, with exception of 
the updating provided for in the fifth paragraph of this Article.” 

(b)  The third and fourth paragraphs are replaced by the following: 

“Within five years of the entry into force of this Regulation, the Commission shall 
present a report on its implementation to the Council. 

Any review of the fees shall be based on an evaluation of the Agency’s costs and on 
the  basis  of  the  related  costs  of  the  services  provided  for  by  the  Member  States. 
Those  costs  shall  be  calculated  in  accordance  with  generally  accepted  international 
costing methods.” 

(c)  The following fifth paragraph is added:  

“With  effect  from  1  April  of  each  year,  the  Commission  shall  review  the  fees  by 
reference  to  the  inflation  rate  as  published  in  the  Official  Journal  of  the  European 
Union and update them. “ 

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19 

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Article 2 
Transitional period 

This Regulation shall not apply to valid applications pending at 20 November 2005. 

Article 3 
Entry into force 

This Regulation shall enter into force on [the third] day following that of its publication in the 
Official Journal of the European Union.  

It shall apply from 20 November 2005.  

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels,  

For the Council 
The President 

EN 

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LEGISLATIVE FINANCIAL STATEMENT 

Policy area(s): Internal Market (Article 95 TEC). 

Activit(y/ies):  The  activities  of  the  European  Medicines  Agency  are  included  in  the 
following policies: 

- Improving the protection of public health across the Community; 

-  Maintaining  a  reliable  and  independent  source  of  scientific  advice  and  information  on 
medicinal products; 

- Supporting the achievement of the internal market for the pharmaceutical sector. 

Title of action: PROPOSAL FOR A COUNCIL REGULATION AMENDING COUNCIL 
REGULATION  (EC)  No  297/95  ON  FEES  PAYABLE  TO  THE  EUROPEAN 
MEDICINES AGENCY (EMEA) 

1. 

BUDGET LINE(S) + HEADING(S) 

02.040201  –  European  Agency  for  the  Evaluation  of  Medicinal  Products  —  Subsidy 
under Titles 1 and 2 

02.040202  –  European  Agency  for  the  Evaluation  of  Medicinal  Products  —  Subsidy 
under Title 3 

2. 

OVERALL FIGURES  

2.1. 

Total allocation for action (Part B): € million for commitment 

2.2. 

Period of application: 

The proposed Regulation should apply from 20 November 2005. The overall impact on revenues 
has  been  calculated  for  2005-2010  and  indicates  a  rough  increase  of  the  gross  revenues  of  the 
Agency from 2 to 4 million euro per year. Nevertheless, additional costs resulting from the new 
tasks provided to the Agency by Regulation (EC) No 726/2004 have not yet been fully assessed. 
As a consequence, the effect on the level of subsidy from the UE budget can only be evaluated in 
a further stage. 

The  detailed  results  of  the  calculation  of  revenues  are  provided  in  Section  10:  Annex  of  the 
Legislative Financial Statement.  

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21 

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2.3. 

Overall multiannual estimate of expenditure: 

(a) 

Schedule  of  commitment  appropriations/payment  appropriations  (financial  intervention) 
(see point 6.1.1) 

€ million (to three decimal places) 

[n+1]

[n+2] 

[n+3] 

[n+4] 

Year 
[n] 

[n+5 
and 
subs. 
Years] 

Total 

Commitments 

Payments 

(b) 

Technical and administrative assistance and support expenditure(see point 6.1.2) 

Commitments 

Payments 

Subtotal a+b 

Commitments 

Payments 

(c) 

Overall  financial  impact  of  human  resources  and  other  administrative  expenditure 
(see points 7.2 and 7.3) 

Commitments/ 
payments 

TOTAL a+b+c 

Commitments 

Payments 

2.4. 

Compatibility with financial programming and financial perspective 

[X]  Proposal is compatible with existing financial programming. 

Proposal  will  entail  reprogramming  of  the  relevant  heading  in  the  financial 
perspective. 

Proposal  may  require  application  of  the  provisions  of  the  Interinstitutional 
Agreement. 

EN 

22 

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2.5. 

Financial impact on revenue:22 

[X]  Proposal  has  no  financial  implications  (involves  technical  aspects  regarding 

implementation of a measure) 

OR 

Proposal has financial impact – the effect on revenue is as follows: 

(NB  All  details  and  observations  relating  to  the  method  of  calculating  the  effect  on 
revenue should be shown in a separate annex.) 

(€ million to one decimal place) 

Budget line 

Revenue 

Prior to
action 
[Year 
n-1] 

[Year 
n] 

Situation following action 

[n+1] [n+2]

[n+3]  [n+4]  [n+5]

a) Revenue in absolute terms 

b) Change in revenue 

 ∆ 

(Please specify each budget line involved, adding the appropriate number of rows to the 
table if there is an effect on more than one budget line.) 

3. 

BUDGET CHARACTERISTICS 

Type of expenditure 

New 

EFTA 
contribution 

Contributions 
form applicant 
countries 

Non-comp 

Non-diff 

NO 

YES 

NO 

Heading in 
financial 
perspective 

No 3 (1a) 

4. 

LEGAL BASIS  

As laid down in Article 67(3) of Regulation (EC) No 726/2004, the Agency's revenue shall consist 
of  a  contribution  from  the  Community  and  fees  paid  by  undertakings  for  obtaining  and 
maintaining Community marketing authorisations and for other services provided by the Agency . 

The  current  amounts  and  structure  of  the  fees  are  laid  down  in  Council  Regulation  (EC)  No 
297/95,  of  10  February  1995,  on  fees  payable  to  the  European  Agency  for  the  Evaluation  of 
Medicinal Products. There is hence a clear legal basis for Community action. 

22 

For further information, see separate explanatory note. 

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23 

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5. 

DESCRIPTION AND GROUNDS 

Details of the context of the proposal are given in the Explanatory Memorandum. 

5.1. 

Need for Community intervention 23 

5.1.1.  Objectives pursued 

(For more details, see Section 2 of the Explanatory Memorandum.) 

The main objectives of the proposal are: 

-  To  adapt  the  existing  fee  scheme  to  the  revised  pharmaceutical  legislation  and  the  new 
responsibilities  conferred  to  the  EMEA,  taking  in  consideration  the  experience  with  the  current 
system; 

- To ensure proportionality between the amount of the fees and the nature of the service actually 
provided by the Agency; 

- To alleviate the financial pressure put on applicants, without undermining the Agency’s ability to 
perform its tasks. 

The proposal’s objectives contribute to the three strategic goals of the Community framework for 
the authorisation, supervision and surveillance of medicinal products, and the establishment of the 
European Medicines Agency, i.e.: 

- Protecting public health across the Community; 

- Maintaining a reliable and independent source of scientific advice and information on medicinal 
products; 

- Supporting the achievement of the internal market for the pharmaceutical sector. 

5.1.2.  Measures taken in connection with ex ante evaluation  

(For  more  details,  see  the  Impact  Assessment  and  Sections  2.3  &  2.4  of  the  Explanatory 
Memorandum.) 

Firstly, an Impact Assessment, which accompanies this Financial Statement, was conducted on the 
Commission’s  proposal.  It  primarily  draws  on  experience  with  the  existing  EU  pharmaceutical 
market and regulatory framework, experience with the current fees scheme, extensive consultation 
with stakeholders (in particular industry associations, see below), and feedback from the EMEA. 

Secondly,  the  Commission  launched  in  July  2004  an  external  consultation  on  its  draft  proposal, 
and  received  numerous  contributions  from  industry  associations,  regulators,  and  individual 
companies. Some of them, especially the ones from industry associations, were the result of wider, 
internal consultation. Contributions were carefully taken in consideration for the refinement of the 
Commission’s draft. 

23 

For further information, see separate explanatory note. 

EN 

24 

   EN 

 
                                                 
5.1.3.  Measures taken following ex post evaluation 

(For more details, see Section 2.2 of the Explanatory Memorandum) 

The EMEA has provided the Commission with an in-depth analysis of the operation of the current 
fee system24. Such analysis has led to three main conclusions: 

-  The  general  principles,  as  well  as  the  overall  structure  of  the  fees,  have  indeed  enabled  the 
Agency to fulfill its mission since 1995; they should therefore be maintained. Thus, most of the 
fees should not be changed. 

-  In  order  to  adequately  cover  post-marketing  costs  and  to  reduce  the  Agency’s  revenues 
dependence  on  the  payment  of  initial  fees  related  to  new  applications,  it  appears  necessary  to 
increase the annual fee. 

- In order to ensure flexibility and to better reflect the actual level of scientific input and service 
provided, the use of graduated fees should be extended. 

5.2. 

Action envisaged and budget intervention arrangements 

Achievement of the objectives and expected results can easily be measured, for instance in terms 
of: 

-Number of medicinal products subject to a scientific evaluation by the EMEA; 

-Number of products granted a Community marketing authorisation and placed on the market; 

-Number of scientific advices given for products in the development phase; 

-Number  of  requests  for  post-marketing  studies,  pharmacovigilance  plans  and  risk  management 
systems, and the delivery against those plans; 

-Number of variations applications and line extensions applications submitted to the Agency; 

-Number of arbitration and Community referrals made to the EMEA; 

etc. 

5.3.  Methods of implementation 

Centralised Management, indirectly by delegation to a body set up by the Communities as referred 
to in art. 185 of the Financial Regulation (EMEA) 

24 

Report  to  the  European  Commission  on  financing  the  European  Agency  for  the  Evaluation  of  Medicinal 
Products, EMEA Management Board, March 2004. 

EN 

25 

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6. 

FINANCIAL IMPACT 

6.1. 

Total financial impact on Part B - (over the entire programming period) 

(The method of calculating the total amounts set out in the table below must be explained by the 
breakdown in Table 6.2. ) 

6.1.1.  Financial intervention 

Commitments (in € million to three decimal places) 

Breakdown 

[Year 
n] 

[n+1] 

[n+2] 

[n+3] 

[n+4] 

Total 

[n+5 
and 
subs. 
Years] 

Action 1 

Action 2 

etc. 

TOTAL 

6.1.2.  Technical  and  administrative  assistance,  support  expenditure  and  IT  expenditure 

(commitment appropriations) 

[Year 
n] 

[n+1] 

[n+2] 

[n+3] 

[n+4] 

Total 

[n+5 
and 
subs. 
years] 

and 

Technical 

1) 
administrative assistance 
a) 
offices 

Technical 

assistance 

and 

technical 

b)  Other 
administrative assistance: 
- intra muros: 
- extra muros: 
of  which  for  construction 
and 
of 
maintenance 
computerised  management 
systems 

Subtotal 1 

2) Support expenditure 

a) Studies 

b) Meetings of experts 

c) Information and 
publications 

Subtotal 2 

TOTAL 

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6.2. 

Calculation of costs by measure envisaged in Part B (over the entire programming 
period)25 

(Where there is more than one action, give sufficient detail of the specific measures to be taken for 
each one to allow the volume and costs of the outputs to be estimated.) 

Breakdown  

Commitments (in € million to three decimal places) 

Type  
of outputs 
(projects, files ) 

Number of 
outputs 

Average unit 
cost 

(total for years 
1…n)  

Total cost 

(total for years 
1…n)  

1 

2 

3 

4=(2X3) 

Action 1 

- Measure 1 

- Measure 2  

Action 2 

- Measure 1 

- Measure 2 

- Measure 3 

etc. 

TOTAL COST 

If necessary explain the method of calculation 

7. 

IMPACT ON STAFF AND ADMINISTRATIVE EXPENDITURE  

7.1. 

Impact on human resources 

Staff to be assigned to management of the 
action using existing and/or additional 
resources 

Number of 
permanent posts 

Number of 
temporary posts 

Total 

Description of tasks deriving from the 
action 

If necessary, a fuller description of the 
tasks may be annexed. 

Types of post 

Officials 
temporary staff 

or 

A 

B 

C 

Other human resources 

Total 

25 

For further information, see separate explanatory note. 

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27 

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7.2. 

Overall financial impact of human resources 

Type of human resources 

Amount (€) 

Method of calculation *  

Officials 

Temporary staff 

Other human resources 

(specify budget line) 

Total 

The amounts are total expenditure for twelve months. 

7.3. 

Other administrative expenditure deriving from the action 

Amount € 

Method of calculation 

Budget line 

(number and heading) 

Overall allocation (Title A7) 

A0701 – Missions 

A07030 – Meetings 
A07031 – Compulsory committees 1 
A07032 – Non-compulsory committees 1 

A07040 – Conferences 

A0705 – Studies and consultations 

Other expenditure (specify) 

Information systems (A-5001/A-4300) 

Other expenditure - Part A (specify) 

Total 

The amounts are total expenditure for twelve months. 

1 Specify the type of committee and the group to which it belongs. 

I. 

II. 

Annual total (7.2 + 7.3) 

Duration of action 

III. 

Total cost of action (I x II) 

€ 

years 

€ 

(In the estimate of human and administrative resources required for the action, DGs/Services must 
take into account the decisions taken by the Commission in its orientation/APS debate and when 
adopting  the  preliminary  draft  budget  (PDB).  This  means  that  DGs  must  show  that  human 
resources can be covered by the indicative pre-allocation made when the PDB was adopted.  

Exceptional cases (i.e. those where the action concerned could not be foreseen when the PDB was 
being prepared) will have to be referred to the Commission for a decision on whether and how (by 
means  of  an  amendment  of  the  indicative  pre-allocation,  an  ad  hoc  redeployment  exercise,  a 
supplementary/amending budget or a letter of amendment to the draft budget) implementation of 
the proposed action can be accommodated.) 

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8. 

FOLLOW-UP AND EVALUATION 

8.1. 

Follow-up arrangements 

Most  of  the  effects  of  the  proposal  lend  themselves  to  direct,  quantitative  measurement. 
Furthermore, Articles 67 to 70 of Regulation (EC) No 726/2004 lay down financial provisions for 
the  annual  preparation,  execution,  monitoring  and  reporting  of  the  EMEA  budget,  including 
revenues from fees paid by undertakings. Consequently, adequate monitoring data (such as the set 
of indicators listed in Section 5.3) will be collected in the context of the implementation of these 
Articles. 

8.2. 

Arrangements and schedule for the planned evaluation 

It is foreseen that within five years of the entry into force of the Regulation, the Commission will 
present  a  report  on  its  implementation.  Future  reviews  will  be  based  on  an  evaluation  of  the 
Agency’s costs and on the basis of the related costs of the services provided for by the Member 
States, and calculated in accordance with generally accepted international costing methods. 

Besides,  the  Agency  will  provide  annually  an  extensive  analysis  of  the  application  of  this 
Regulation, through its Annual Report. 

9. 

ANTI-FRAUD MEASURES 

The European Medicines Agency has specific budgetary control mechanisms and procedures. The 
Management Board, which comprises representatives of the Member States, the Commission and 
the  European  Parliament,  adopts  the  budget  (Article  66(f)  of  Regulation  (EC)  No  726/2004),  as 
well as the internal financial provisions (Article 66(g)). The European Court of Auditors examines 
the execution of the budget each year (Article 68.3).  

Regarding fraud, corruption  and  other unlawful activities, the  provisions of  Regulation (EC) No 
1073/1999  of  the  European  Parliament  and  of  the  Council  of  25  May  1999  concerning 
investigations conducted by the European Anti-Fraud Office (OLAF) apply to the EMEA without 
restriction. Besides, a decision concerning co-operation with the OLAF was already adopted on 1 
June 1999 (EMEA/D/15007/99). 

Finally,  the  Quality  Management  System  applied  by  the  Agency  supports  a  continuous  review, 
whose objective is to ensure that the correct procedures are followed and that these procedures and 
policies are pertinent and efficient. Several internal audits are undertaken each year as part of this 
process. 

10. ANNEX: DETAILED CALCULATION OF THE PROPOSAL’S FINANCIAL IMPACT 

The Commission’s proposal aims at amending the current legal framework on the fees payable to 
the EMEA, as laid down in Council Regulation (EC) No 297/95, as amended, in order to take into 
account the new tasks of the Agency, as well as the modifications of existing tasks introduced by 
the recent revision of the pharmaceutical legislation. 

As laid down in Article 67(3) of Regulation (EC) No 726/2004, the Agency’s revenues consist of 
a contribution from the Community, and fees paid by companies. As this proposal introduces new 
fees,  it  is  necessary  to  assess  the  quantitative  impact  of  this  new  scheme,  in  order  to  further 
determine whether or not it would imply a reconsideration of the Community contribution. 

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29 

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Methodology 

Nota Bene: Evidently, the financial impact of Regulation (EC) No 726/2004 as such lies outside 
the scope of this Financial Legislative Statement, since it was already addressed in the context of 
the global revision of the pharmaceutical legislation26. 

The Commission’s proposal introduces, for a limited subset of fee types, changes (either increases 
or decreases) in amounts payable to the EMEA (see Table 1). 

For these fees where changes are introduced, the numbers of corresponding applications have been 
estimated,  in  collaboration  with  the  EMEA,  for  the  2006-2010  time  period27.  This  enables  to 
forecast  the  financial  impact  of  the  fees  changes  over  that  period,  and  to  compare  it  to  the 
Agency’s total revenues forecast, as provided by the EMEA28. 

Results 

The results are given in Tables 2-4. For ease of reference and comparison, the estimates for year 
2004 are also provided. 

The forecast shows that the overall impact of the fees changes: 

-represents 2.8 to 3% of the Agency’s annual revenues from fees; 

-represents 1.9 to 2.5% of the Agency’s total annual revenues (fees + Community contribution); 

Given  that  the  error  margin  for  the  revenues  forecasts  is  about  5-10%,  and  that  the  calculation 
does not take into account inflation, which at present is around 2.1% in the EU, the overall impact 
of  the  fees  changes,  compared  to  the  Agency’s  total  revenues,  is  relatively  moderate  (less  than 
2.5%). 

However, in absolute numbers, this still represents 2 to 4 millions Euros per year and 9% to 15% 
of  the  general  subsidy  entered  in  budget  2005,  which  cannot  be  considered  entirely  negligible. 
This should therefore be taken into account in the next budgetary procedures, when reviewing the 
Community contribution to the EMEA for the 2005-2010 time period. For that review, the ‘fees’ 
parameter  will  also  have  to  be  balanced  with  the  costs  incurred  by  the  Agency  for  the 
implementation of Regulation (EC) No 726/2004. 

26 
27 
28 

For more details, see 2001/0252 (COD) 
As the new Regulation will apply from 20 November 2005, the impact for 2005 is assumed to be negligible. 
For  more  details  on  revenues  forecasts,  see  the  ‘Report  to  the  European  Commission  on  financing  of  the 
EMEA’, Management Board of the EMEA, March 2004. 

EN 

30 

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Table 1: EMEA Fees changes introduced by the Commission’s proposal. Changes are highlighted in bold (4th column) 

(in Euros) 

Human
Full fee 

Reduced fee 

Extension fee 

Type I variation 

Type II variation 

Renewal 
Inspection 
Transfer 
Annual fee 
Referral 

Scientific advice 
Scientific services 
Administrative services 

Veterinary
Full fee 

Full fee vaccines 

Reduced fee 

Reduced fee vaccines 

EN 

base 
addit. strength/form 
addit. presentation 
base 

addit. strength/form 
addit. presentation 

new strength/form etc. 
new presentation 

base 
addit. strength/form 
addit. presentation 
vaccines 
addit. strength/form/pres. 
base 

addit. strength/form 
addit. presentation 
vaccines 
addit. strength/form/pres. 

Current

232000 
23200 
5800 
116000 

23200 
5800 

58000 
11600 
5800 

69600 

11600 
17400 
5800 
75600 
58000 

69600 

5800 

116000 
11600 
5800 
58000 
5800 
58000 

11600 
5800 
29000 
5800 

generic 
bio-similar 

max 

IA 
IB 
max 

max 

max 

max 
max 
max 

immunologicals 

generic 
bio-similar 

immunologicals 

31 

Proposal

232000 
23200 
5800 
90000 
150000 
9000 
5800 

69600 
5800 
2500 
5800 
69600 

11600 
17400 
5800 
83200 
58000 

69600 
232000 
5800 

116000 
11600 
5800 
58000 
5800 
58000 
98000 
11600 
5800 
29000 
5800 

Dif.

0% 
0% 
0% 
-22% 
NEW 
-61% 
0% 

20% 
-50% 
-57% 
0% 
0% 

0% 
0% 
0% 
10% 
0% 

0% 
NEW 
0% 

0% 
0% 
0% 
0% 
0% 
0% 
NEW 
0% 
0% 
0% 
0% 

Ref.

Art. 3(1)(a) 
Art. 3(1)(a) 
Art. 3(1)(a) 
Art. 3(1)(b) 
Art. 3(1)(b) 
Art. 3(1)(b) 
Art. 3(1)(b) 

Art. 3(1)(c) 
Art. 3(1)(c) 
Art. 3(2)(a) 
Art. 3(2)(a) 
Art. 3(2)(b) 

Art. 3(3) 
Art. 3(4) 
Art. 3(5) 
Art. 3(6) 
Art. 4 

Art. 8(1) 
Art. 8(2) 
Art. 8(3) 

Art. 5(1)(a) 
Art. 5(1)(a) 
Art. 5(1)(a) 
Art. 5(1)(a) 
Art. 5(1)(a) 
Art. 5(1)(b) 
Art. 5(1)(b) 
Art. 5(1)(b) 
Art. 5(1)(b) 
Art. 5(1)(b) 
Art. 5(1)(b) 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
new strength/form etc. 
new presentation 
vaccines 

vaccines 

base 
amend/extend existing MRL 
clinical trials 

Extension fee 

Type I variation 

Type II variation 

Renewal 
Inspection 
Transfer 
Annual fee 
Referral 
MRL fee 

Scientific Advice 
Scientific services 
Administrative services 

29000 
5800 
5800 
5800 

34800 
5800 

5800 
17400 
5800 
25200 
34800 
58000 
17400 
17400 

34800 

5800 

max 

(vaccines 
IA 
IB 
max 

max 

max 

max 
max 
max 

29000 
5800 
5800 
2500 
5800 
34800 
5800 

5800 
17400 
5800 
27700 
34800 
58000 
17400 
17400 

34800 
116000 
5800 

0% 
0% 
0% 
-57% 
0% 
0% 
0% 

0% 
0% 
0% 
10% 
0% 
0% 
0% 
0% 

0% 
NEW 
0% 

Art. 5(1)c 
Art. 5(1)c 
Art. 5(1)c 
Art. 5(2)(a) 
Art. 5(2)(a) 
Art. 5(2)(b) 
Art. 5(2)(b) 

Art. 5(3) 
Art. 5(4) 
Art. 5(5) 
Art. 5(6) 
Art. 6 
Art. 7 
Art. 7 
Art. 7 

Art. 8(1) 
Art. 8(2) 
Art. 8(3) 

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Human 

  Current 

Proposal 

Dif. 

Reduced fee 

generic 

116000 

90000 

-26000 

biosimilar 

- 

150000 

150000 

addit. 
strength/form 

new 
strength/form 
etc. 
new presentation 

Type IA 

Maximum 

VAMF/PMF 

Other 

biosimilar 

Type IA 

23200 

9000 

-14200 

58000 

69600 

11600 

11600 

5800 

75600 

- 

- 

- 

- 

5800 

25200 

5800 

2500 

83200 

232000 

-5800 

-3300 

7600 

30000 

30000 

150000 

150000 

98000 

98000 

2500 

27700 

-3300 

2500 

- 

116000 

116000 

Extension fee 

Type I variation 

Annual fee 

Scientific services 

Veterinary 

Reduced fee 

Type I variation 

Annual fee 

Scientific services 

2004 

# files 

0 

- 

0 

8 

4 

280 

214 

- 

- 

- 

25 

35 

- 

2005 

2006 

# files 

0 

- 

0 

# 
files 
3 

3 

0 

financial 
impact 
-78000 

450000 

0 

10 

10 

116000 

5 

300 

241 

- 

- 

- 

30 

38 

- 

5 

330 

264 

15 

3 

0 

35 

42 

0 

-29000 

-1089000 

2006400 

450000 

450000 

0 

-115500 

105000 

0 

2265900 

80397000 

2,8% 

Total Impact 

Total EMEA Revenues from fees 

RELATIVE IMPACT (%) 

Total EMEA Revenue (fees+Community 
contribution) 
RELATIVE IMPACT (%) 

64800000 

73700000 

96619000 

108237000 

117615000 

1,9% 

Table  2:  Financial  impact  of  the  proposal  for  2005-2006.  Financial  figures  are  given  in  Euros.  Estimates  for 
year 2004 are also provided, for information. As the new Regulation will apply from 20 November 2005, the 
impact for 2005 is assumed to be negligible. 

Note:  Regarding  Scientific  services  for  medicinal  products  for  human  use,  the  Commission’s  proposal 
introduces a wide range of fees amounts (from 2500 Euros to 232 000 Euros), depending on the type of service 
actually provided. The calculation is based on the assumption that the fees for certification of Vaccine Antigen 
Master Files and Plasma Master Files (VAMF/PMF) will be about 30000 Euros, and that other services will be 
charged 150000 Euros on average. 

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33 

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Human 

Reduced fee 

Extension fee 

Type I variation 

Annual fee 

Scientific services 

Veterinary 

Reduced fee 

Type I variation 

Annual fee 

Scientific services 

2007 

Dif. 

# files 

generic 

biosimilar 

addit. 
strength/form 

new 
strength/form etc. 
new presentation 

Type IA 

Maximum 

VAMF/PMF 

Other 

Current  Proposa
l 
90000 

116000 

-26000 

- 

150000 

150000 

23200 

9000 

-14200 

58000 

69600 

11600 

11600 

5800 

5800 

2500 

75600 

83200 

-5800 

-3300 

7600 

- 

- 

- 

232000 

30000 

30000 

150000 

150000 

biosimilar 

- 

98000 

98000 

Type IA 

5800 

2500 

25200 

27700 

-3300 

2500 

- 

116000 

116000 

Total Impact 

Total EMEA Revenues from fees 

RELATIVE IMPACT (%) 

Total EMEA Revenue (fees+Community 
contribution) 
RELATIVE IMPACT (%) 

6 

5 

1 

12 

6 

355 

280 

20 

5 

0 

40 

47 

0 

2008 

# files 

8 

6 

1 

14 

7 

380 

307 

18 

5 

0 

46 

53 

0 

financial 
impact 
-156000 

750000 

-14200 

139200 

-34800 

-1171500 

2128000 

600000 

750000 

0 

-132000 

117500 

0 

2976200 

90416000 

3,3% 

128567000 

financial 
impact 
-208000 

900000 

-14200 

162400 

-40600 

-1254000 

2333200 

540000 

750000 

0 

-151800 

132500 

0 

3149500 

99518000 

3,2% 

138446000 

2,3% 

2,3% 

Table 3: Financial impact of the proposal for 2007-2008. Financial figures are given in Euros. 

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Human 

  Current 

Proposal 

Dif. 

# files 

2009 

Reduced fee 

generic 

116000 

90000 

-26000 

biosimilar 

- 

150000 

150000 

23200 

9000 

-14200 

financial 
impact 
-260000 

900000 

-28400 

2010 

# files 

12 

7 

3 

financial 
impact 
-312000 

1050000 

-42600 

10 

6 

2 

addit. 
strength/form 

new 
strength/form 
etc. 
new 
presentation 
Type IA 

Extension fee 

Type I variation 

Annual fee 

Scientific services 

Maximum 

VAMF/PMF 

Other 

biosimilar 

Type IA 

Veterinary 

Reduced fee 

Type I variation 

Annual fee 

Scientific services 

Total Impact 

Total EMEA Revenues from fees 

RELATIVE IMPACT (%) 

Total EMEA Revenue (fees+Community 
contribution) 
RELATIVE IMPACT (%) 

58000 

69600 

11600 

17 

197200 

19 

220400 

11600 

5800 

-5800 

8 

-46400 

9 

-52200 

5800 

75600 

- 

- 

- 

- 

5800 

25200 

2500 

83200 

232000 

-3300 

7600 

30000 

30000 

150000 

150000 

98000 

98000 

2500 

27700 

-3300 

2500 

- 

116000 

116000 

410 

335 

20 

7 

1 

50 

57 

0 

-1353000 

2546000 

600000 

1050000 

98000 

-165000 

142500 

0 

3680900 

110780000 

3,3% 

149493000 

450 

360 

19 

8 

1 

58 

62 

0 

-1485000 

2736000 

570000 

1200000 

98000 

-191400 

155000 

0 

3946200 

121455000 

3,2% 

161145000 

2,5% 

2,4% 

Table 4: Financial impact of the proposal for 2009-2010. Financial figures are given in Euros. 

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