The European Parliament adopted a resolution drafted by Francoise GROSSETETE (EPP-ED, FR) on the proposal amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the implementing powers conferred on the Commission. It made some amendments to the Commission’s proposal:
- Article 107 was amended to read that the decision on the final measures concerning the product shall be adopted in accordance with the procedure referred to in Article 121(3). Article 107 concerns a particular medicinal product for which a Member State has considered taking regulatory action on pharmacovigilance grounds;
- the rules of procedure of the Standing Committee shall be made public.