Activities of Françoise GROSSETÊTE related to 2008/0257(COD)
Plenary speeches (2)
Explanations of vote
Pharmacovigilance of medicinal products (amendment of Regulation (EC) No 726/2004) - Pharmacovigilance (amendment of Directive 2001/83/EC) (debate)
Amendments (2)
Amendment 39 #
Proposal for a regulation – amending act
Article 1 – point 5 b
Article 1 – point 5 b
Regulation EC/726/2004
Article 14 – paragraph 3
Article 14 – paragraph 3
3. Once renewed, the marketing authorisation shall be valid for an unlimited period, unless the national competent authority decides, on justified grounds relating to pharmacovigilance or to insufficient exposure to the product, to proceed with one additional five-year renewal in accordance with paragraph 2.”
Amendment 48 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation EC/726/2004
Article 25
Article 25
The Agency, in collaboration with the Member States, shall develop standard web-based structur and all relevant stakeholders, shall develop standard structured forms and procedures, including web-based forms, for the reporting of suspected adverse reactions by health-care professionals and patients. To ensure the traceability of biological medicinal products prescribed, dispensed or sold in the territory of the Union the standard forms and procedures shall include the name of the MAH, the INN, the name of the medicinal product as defined in Article 1(2) and the batch number.