19.12.98 Official Journal of the European Communities L 345/3 (Acts whose publication is obligatory) COUNCIL REGULATION (EC) No 2743/98 of 14 December 1998 amending Regulation (EC) No 297/95 on fees payable to the European Agency for the Evaluation of Medicinal Products 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 (') (here- inafter referred to as the ‘Agency’), and in particular Article 10 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Parlia- ment (%), Whereas under Article 57(1) of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medi- cinal products for human and veterinary use and estab- lishing a European Agency for the Evaluation of Medi- cinal Products (%), the revenues of the Agency consist of a contribution and the fees paid by undertakings for obtaining and maintaining a Community marketing authorisation and for other services provided by the Agency; Whereas the amounts and structure of the fees established by Regulation (EC) No 297/95 must be reviewed by 31 December 1997; Whereas, 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 opera- tional and procedural provisions established by the above- mentioned Regulation; Whereas for certain fees, however, the services to which they relate should be specified so as to facilitate their collection and improve the transparency and practical implementation of this Regulation; (") OJ L 35, 15. 2. 1995, p. 1. (3 OJ C 328, 26. 10. 1998. () OJ L 214, 24. 8. 1993, p. 1. Regulation as amended by Commission Regulation (EC) No 649/98 (O] L 88, 24. 3. 1998, p. 7). Whereas new fees must also be established to cover all the services now provided by the Agency; Whereas an annual fee must be introduced to ensure coverage of the costs connected with the supervision of authorised medicinal products; whereas a given part of this fee will have to be allocated to the competent national authorities required under the terms of Regula- tion (EEC) No 2309/93 to supervise the market on behalf of the Community; whereas, moreover, the rules for distribution amongst those authorities will have to be adopted by the Agency’s Management Board in accord- ance with the procedure laid down in this Regulation; Whereas in certain exceptional cases and for imperative reasons of public or animal health it must be possible to reduce the abovementioned fees; whereas, therefore, without prejudice to more specific provisions of Community law, any decision to reduce fees will have to be taken by the Executive Director on the basis of a critical examination of the situation specific to each case after consultation of the competent scientific committee, HAS ADOPTED THIS REGULATION: Article 1 Regulation (EC) No 297/95 is hereby amended as follows: 1. Article 1 shall be replaced by the following: ‘Article 1 Scope Fees for obtaining and maintaining a Community authorisation to market medicinal products for human and veterinary use and for other services supplied by the Agency shall be levied in accordance with this Regulation. The amounts of these fees shall be laid down in ecus.