23.11.2005 EN Official Journal of the European Union L 304/1
COUNCIL REGULATION (EC) No 1905/2005
of 14 November 2005
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 Products (1), and in particular Article 12 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Parliament (2),
Whereas:
(1) 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 Agency (3), 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.
(2) Regulation (EC) No 726/2004 also provides for new tasks for the Agency. Furthermore, the existing tasks have also been changed following amendments 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 products (4) and to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (5).
(3) 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.
(4) 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.
(5) 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.
(6) 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, since the levels of fees laid down in this Regulation are set as maximum fees, the Management Board should establish, for certain services for which this is laid down in the Regulation, detailed classifications and lists of reduced fees.
(7) 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 Director 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 origin (6).
(8) 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.
(9) 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.
(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,
Regulation (EC) No 297/95 shall be amended as follows:
1. the second paragraph of Article 1 shall be replaced by the following:
2. Article 3 is amended as follows:
(a) the title shall be replaced by the following:
(b) paragraph 1 is amended as follows:
(i) in point (a) the first and second subparagraph shall be replaced by the following:
(ii) points (b) and (c) shall be replaced by the following:
‘(b) Reduced fee
(c) Extension fee
(c) paragraph 2 is amended as follows:
(i) in point (a) the first subparagraph shall be replaced by the following:
(ii) in point (b) the first subparagraph shall be replaced by the following:
(d) paragraph 4 is amended as follows:
(i) the sole subparagraph shall be replaced by the following:
(ii) the following subparagraph shall be added:
(e) paragraph 6 shall be replaced by the following:
3. Article 4 shall be replaced by the following:
4. Article 5 is amended as follows:
(a) the title shall be replaced by the following:
(b) paragraph 1 is amended as follows:
(i) point (a) shall be amended as follows:
— the first and second subparagraph shall be replaced by the following:
— the fourth subparagraph shall be replaced by the following:
(ii) point (b) shall be replaced by the following:
‘(b) Reduced fee
(iii) point (c) shall be replaced by the following:
‘(c) Extension fee
(c) paragraph 2 is amended as follows:
(i) in point (a) the first subparagraph shall be replaced by the following:
(ii) point (b) shall be replaced by the following:
(d) paragraph 4 is amended as follows:
(i) the sole subparagraph shall be replaced by the following:
(ii) the following subparagraph shall be added:
(e) paragraph 6 shall be replaced by the following:
5. Article 6 shall be replaced by the following:
6. Article 7 is amended as follows:
(a) the title shall be replaced by:
(b) in paragraph 1 the second subparagraph shall be replaced by the following:
(c) paragraph 2 shall be deleted and the numbering of paragraph 1 shall be deleted;
7. Article 8 shall be replaced by the following:
8. in Article 9 the second paragraph shall be replaced by the following:
9. Article 10 shall be replaced by the following:
10. Article 11(2) shall be replaced by the following:
11. Article 12 is amended as follows:
(a) the second paragraph shall be replaced by the following:
(b) the third and fourth paragraphs shall be replaced by the following:
(c) the following paragraph shall be added:
Transitional period
This Regulation shall not apply to valid applications pending at 20 November 2005.
Entry into force
This Regulation shall enter into force on the day following 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.