Activities of Jens ROHDE related to 2008/0257(COD)
Plenary speeches (1)
Explanations of vote
Shadow opinions (1)
OPINION Proposal for a regulation of the European Parliament and of the Council amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
Amendments (2)
Amendment 26 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation (EC) No 726/2004
Article 25 – paragraph 1 a (new)
Article 25 – paragraph 1 a (new)
To ensure the traceability of biological medicinal products prescribed, dispensed or sold on EU territory the standard forms and procedures shall include the name of the marketing authorisation holder, the International Non-proprietary Name (INN), the name of the medicinal product as defined in point 20 of Article 1 of Directive 2001/83/EC and the batch number.
Amendment 28 #
Proposal for a regulation – amending act
Article 1 – point 14
Article 1 – point 14
Regulation (EC) No 726/2004
Article 61 a – paragraph 1
Article 61 a – paragraph 1
1. The Pharmacovigilance Risk Assessment Advisory Committee shall be composed of the following: (a) tenone members and tenone alternates appointed by the Management Board, on the basis of proposals by the national competent authorities; (b) five members and five alternates per Member State, appointed by the national competent authority in consultation with the Management Board; (b) two additional members and two alternates, one a representative of healthcare professionals and one a representative of patients, appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament. The alternates shall represent and vote for the members in their absence. TA Member State may request another Member State to take its place in the Ccommission may adapt the number of members and alternates in the light of technical and scientific needs. Those measures, designed to amend non- essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a)ttee. The alternates shall represent and vote for the members in their absence.