2 Amendments of Frédérique RIES related to 2008/0257(COD)
Amendment 24 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation (EC) No 726/2004
Article 25
Article 25
The Agency, in collaboration with the Member States, shall develop standard web-based structured form and relevant stakeholders, shall develop standard content, formats and procedures for the reporting of suspected adverse reactions by health-care professionals and patients and the traceability of biological medicinal products prescribed, dispensed, or sold on EU territory.
Amendment 49 #
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 structured form and relevant stakeholders, shall develop standard content, format and procedures for the reporting of suspected adverse reactions by health-care professionals and patients and the traceability of biological medicinal products prescribed, dispensed, or sold in the territory of the Union.