Activities of Michail TREMOPOULOS related to 2008/0257(COD)
Plenary speeches (1)
Pharmacovigilance of medicinal products (amendment of Regulation (EC) No 726/2004) - Pharmacovigilance (amendment of Directive 2001/83/EC) (debate)
Amendments (2)
Amendment 15 #
Proposal for a regulation – amending act
Recital 2 a (new)
Recital 2 a (new)
Amendment 66 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation EC/726/2004
Article 28e a (new)
Article 28e a (new)
Article 28(ea) Environmental monitoring Member States shall appoint one or several authorities to monitor the adverse environmental effects of medicinal products. If one of these authorities identifies an environmental risk that is higher than that indicated in the evaluation pursuant to Article 8(3)(ca), or if it finds new adverse environmental effects, it shall forthwith transmit all findings to the competent authority, which shall forward those findings to the Agency. The Agency shall, upon receiving such information, assess whether the risk- benefit balance remains favourable, taking into account the new findings.