Regulation 2005/1905 - Amendment of Regulation (EC) No 297/95 on fees payable to the European Medicines Agency - Main contents
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official title
Council Regulation (EC) No 1905/2005 of 14 November 2005 amending Regulation (EC) No 297/95 on fees payable to the European Medicines Agency| Legal instrument | Regulation |
|---|---|
| Number legal act | Regulation 2005/1905 |
| Original proposal | COM(2005)106  |
| CELEX number i | 32005R1905 |
| Document | 14-11-2005 |
|---|---|
| Publication in Official Journal | 23-11-2005; Special edition in Croatian: Chapter 13 Volume 063,OJ L 175M , 29.6.2006,Special edition in Romanian: Chapter 13 Volume 049,Special edition in Bulgarian: Chapter 13 Volume 049,OJ L 304, 23.11.2005 |
| Effect | 20-11-2005; Application See Art 3 24-11-2005; Entry into force Date pub. + 1 See Art 3 |
| End of validity | 31-12-2024; Implicitly repealed by 32024R0568 |
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... |
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