2 Amendments of Werner LANGEN related to 2008/0260(COD)
Amendment 33 #
Proposal for a directive – amending act
Recital 5
Recital 5
(5) For the sake of clarity, the definition of adverse reaction should be amended to ensure that it not only covers noxious and unintended effects derived from the authorised use of a medicinal product at the normal doses, but also noxious and unintended effects derived from medication errors and uses outside the authorised summary of the product characteristics, including the misuse and abuse of the product.
Amendment 36 #
Proposal for a directive – amending act
Recital 9
Recital 9
(9) Where a medicinal product is authorized subject to the requirement to conduct a post-authorisation safety study or where there are conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be intensively monitored on the market. In that connection, it is essential that improving the pharmacovigilance system does not result in marketing authorisations for medicinal products being issued prematurely. Patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products, and a publicly available list of such medicinal products should be maintained up to date by the European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (hereinafter referred to as the ‘Agency’).