S.L. 458.35 Art. 51Decisions to be adopted by the Commission.

(1) On the basis of the opinion of the Agency’s Committee for Medicinal Products for Human Use referred to in regulation 50, the Commission shall:

(a) adopt a decision addressed to the Member States concerning the measures to be taken in respect of marketing authorisations granted by the Member States and concerned by the procedure provided for herein; and

(b) where the opinion states that regulatory action concerning the marketing authorisation is necessary, adopt a decision to vary, suspend or revoke the marketing authorisations granted in accordance with the centralised procedure provided for in Regulation

(EC) No 726/2004 and concerned by the procedure provided for herein.

(2) Articles 33 and 34 of Directive 2001/83/EC as amended shall apply to the adoption of the decision referred to in sub-regulation (1)(a) and to its implementation by the Member States.