2 Amendments of Daciana Octavia SÂRBU related to 2008/0260(COD)
Amendment 40 #
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. It is essential that a strengthened system of pharmacovigilance does not lead to the premature granting of market authorisations. 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 Agency12 (hereinafter referred to as the ‘Agency’).
Amendment 63 #
Proposal for a directive – amending act
Recital 20 a (new)
Recital 20 a (new)
(20a) Reporting through health professionals should be especially encouraged in cases where their input could be essential to understanding the adverse reaction. In order to facilitate this reporting, health professionals’ access to medication data contained in the patient health record should be facilitated, in accordance with data protection rules.