Amended proposal for a Council Regulation (EC) amending Regulation (EC) No 297/95 on fees payable to the European Agency for the Evaluation of Medicin al Products
10. 2. 1999 EN Official Journal of the European Communities C 36/17 II (Preparatory Acts) COMMISSION Amended proposal for a Council Regulation (EC) amending Regulation (EC) No 297/95 on fees payable to the European Agency for the evaluation of medicinal productsØ(˛) (1999/C 36/09) COM(1998) 648 final - 98/0135(CNS) (Submitted by the Commission pursuant to Article 189a(2) of the EC Treaty on 12 November 1998) (˛) OJ C 22, 27. 1. 1999, p. 11. Following the opinion of the European Parliament of 7 October 1998, the initial Commission proposal (COM(1998) 21 final) is hereby amended as follows: ORIGINAL TEXT AMENDED TEXT Article 1, point 2) Article 3(2), point a), single subparagraph a) (new) (Regulation (EC) No 297/95) In the event of the same amendment being introduced, this fee shall cover all authorised strengths, pharmaÜ ceutical forms and presentations. Article 3(2), point b), single subparagraph a) (new) (Regulation (EC) No 297/95) In the event of the same amendment being introduced, this fee shall cover all authorised strengths, pharmaÜ ceutical forms and presentations. Article 5(2), point a), single subparagraph a) (new) (Regulation (EC) No 297/95) In the event of the same amendment being introduced, this fee shall cover all authorised strengths, pharmaÜ ceutical forms and presentations. Article 5(2), point b), third subparagraph (new) (Regulation (EC) No 297/95) In the event of the same amendment being introduced, this fee shall cover all authorised strengths, pharmaÜ ceutical forms and presentations. C 36/18 EN Official Journal of the European Communities 10. 2. 1999 ORIGINAL TEXT AMENDED TEXT Article 6, second subparagraph (Regulation (EC) No 297/95) This fee shall be increased by ECU 15Ø000 where the procedures laid down in Articles 19 and 20 of Directive 81/851/EEC are instigation of the initiated at the applicant for or holder of the marketing authorisation. This fee shall be increased by ECU 20Ø000 where the procedures laid down in Articles 19 and 20 of Directive 81/851/EEC are instigation of the initiated at the applicant for or holder of the marketing authorisation. Article 7(1), second subparagraph (Regulation (EC) No 297/95) An additional MRL fee of ECU 10Ø000 shall be payable for each application to amend or extend an existing MRL, including to cover new species. An additional MRL fee of ECU 15Ø000 shall be payable for each application to amend or extend an existing MRL, or to cover new species. Article 8, point 1 (Regulation (EC) No 297/95) This fee shall be charged where an application is made for scientific or technical advice concerning a medicinal product before an application is submitted for authoÜ risation to market it. This fee shall be charged where an application is made for scientific or technical advice concerning a medicinal product before an application is submitted for authoÜ risation to market it. - For medicinal products for human use the fee is set - For medicinal products for human use the maximum at ECU 60Ø000. fee is set at ECU 60Ø000. - For medicinal products for veterinary use the fee is - For medicinal products for veterinary use the set at ECU 30Ø000. maximum fee is set at ECU 30Ø000. The implementing rules for this Article shall be adopted under the procedure laid down in Article 11(2). Article 12, third subparagraph a) (new) (Regulation (EC) 297/95) Future reviews of fees shall be based on a full cost evaluation of the costs of the Agency, including expenÜ diture relating to Member States’ rapporteurs