2 Amendments of Peter LIESE related to 2008/0257(COD)
Amendment 75 #
Proposal for a regulation – amending act
Article 1 – point 14
Article 1 – point 14
Regulation EC/726/2004
Article 61a – paragraph 1 – point b a (new)
Article 61a – paragraph 1 – point b a (new)
(ba) one representative (and alternate) from the EMEA Patient and Consumer’s Working Party and one representative (and alternate) from the EMEA Healthcare Professionals Working Group.
Amendment 82 #
Proposal for a regulation – amending act
Article 1 – point 18 a (new)
Article 1 – point 18 a (new)
Regulation EC/726/2004
Article 80a (new)
Article 80a (new)
(18a) The following Article is inserted: Article 80a Holders of marketing authorisations may appeal against assessment reports or opinions by the Committee mentioned in point (aa) of Article 56(1) of this Regulation in order to review its decisions by an Agency body independent from the Agency’s Committees. The appropriate measures and procedures shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a) of this Regulation.