Verbatim report of proceedings

Thursday, 29 November 2007 - Brussels

7.12. Community code relating to medicinal products for human use (implementing powers conferred on the Commission) (vote)

- Report: Françoise Grossetête (A6-0277/2007)

  Siim Kallas, Vice-President of the Commission. − Commission Statement

The Commission is preparing a legislative proposal, which is on its 2008 legislative programme, to amend the Community drug-monitoring system for medicinal products for human use. There will be a radical overhaul of Title IX (‘Pharmacovigilance’) of Directive 2001/83/EC.

In this proposal, the Commission undertakes to propose recourse to the regulatory procedure referred to in Articles 5 and 7 of Decision 1999/468/EC for the adoption of final public-health protection measures in respect of marketing authorisations which may be necessitated as a result of evaluation of pharmacovigilance data (measures provided for in the new proposal to amend or replace the fourth subparagraph of Article 107(2) of Directive 2001/83/EC).

In its future proposals, the Commission also intends to maintain the existing situation whereby, under Article 107, the Commission may request Member States to take temporary measures immediately where urgent action to protect public health is necessary, without recourse to any committee procedure; it will continue recourse to the management procedure referred to in Articles 4 and 7 of Decision 1999/468/EC for the adoption of any other decision of an individual nature in relation to marketing authorisations for medicinal products.