OpenLegislation

Article 11 Implementing rulesF1

United Kingdom

Original text. Later amendments are not shown.

  1. 1..

    On a proposal from the Executive Director and following a favourable opinion from the Commission, the Agency's Management Board shall fix the rules for repaying a part of the resources deriving from the annual fees to the competent national authorities involved in Community market supervision.

  2. 2..

    F2Without prejudice to the provisions of Regulation (EC) No 726/2004, the Management Board of the Agency may, on a proposal from the Executive Director and following a favourable opinion from the Commission, specify any provision necessary for the application of this Regulation. Those provisions shall be made publicly available.

  3. 3..

    In the event of disagreement as to the classification of an application in one of the fee categories laid down in this Regulation, the Executive Director shall give a ruling after consultation of the competent scientific committee.

Annotations

Textual amendments

F1

Inserted by Council Regulation (EC) No 2743/98 of 14 December 1998.

F2

Substituted by Council Regulation (EC) No 1905/2005 of 14 November 2005 amending Regulation (EC) No 297/95 on fees payable to the European Medicines Agency.

Notes on the whole EU Regulation

Textual amendments

F1

Regulation revoked in part (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(b) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)