CELEX: 51998PC0648
Language: en
Date: 1998-11-11
Title: 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(Î)
                                                    (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)
          (Î)ÙOJ 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, pharma-
                                                                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, pharma-
                                                                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, pharma-
                                                                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, pharma-
                                                                ceutical forms and presentations.
 ---pagebreak--- 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               This fee shall be increased by ECU 20Ø000 where the
procedures laid down in Articles 19 and 20 of Directive           procedures laid down in Articles 19 and 20 of Directive
81/851/EEC are initiated at the instigation of the                81/851/EEC are initiated at the instigation of the
applicant for or holder of the marketing authorisation.           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              An additional MRL fee of ECU 15Ø000 shall be payable
for each application to amend or extend an existing               for each application to amend or extend an existing
MRL, including to cover new species.                              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            This fee shall be charged where an application is made
for scientific or technical advice concerning a medicinal         for scientific or technical advice concerning a medicinal
product before an application is submitted for autho-             product before an application is submitted for autho-
risation to market it.                                            risation to market it.
—ÙFor medicinal products for human use the fee is set             —ÙFor medicinal products for human use the maximum
    at ECU 60Ø000.                                                    fee is set at ECU 60Ø000.
—ÙFor medicinal products for veterinary use the fee is            —ÙFor 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 expen-
                                                                  diture relating to Member States’ rapporteurs.