3 Amendments of Elena Oana ANTONESCU related to 2008/0260(COD)
Amendment 42 #
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 174 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 102 – paragraph 1 – point 1
Article 102 – paragraph 1 – point 1
(1) take all appropriate measures to encourage patients, doctors, pharmacists and other health-care professionals to report suspected adverse reactions to the national competent authority or the marketing authorisation holder; those measures shall include training for health professionals and for patients and a public information campaign for patients;
Amendment 180 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 102 – point 1 a (new)
Article 102 – point 1 a (new)
(1a) facilitate direct patient reporting through the provision of alternative reporting formats (email, telephone, fax and letter) in addition to web-based formats;