Activities of Anja WEISGERBER 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 (8)
Amendment 11 #
Proposal for a regulation – amending act
Recital 15
Recital 15
(15) Where a medicinal product is authorized subject to the requirement to conduct a post-authorisation safety study or subject to conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be intensivecontinuously monitored on the market. PAs with all medicines, 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 kept up to date by the Agency.
Amendment 14 #
Proposal for a regulation – amending act
Article 1 — point 11
Article 1 — point 11
Regulation (EC) No 726/2004
Article 23 – paragraph 1
Article 23 – paragraph 1
The Agency shall establish and make public a list of medicinal products for human use under intensive monitoring.
Amendment 18 #
Proposal for a regulation – amending act
Article 1 — point 11
Article 1 — point 11
Regulation (EC) No 726/2004
Article 26 — point 4
Article 26 — point 4
(4) the list of medicinal products under intensive monitoring referred to in Article 23 of this Regulation whose authorisation is subject to certain conditions or requirements;
Amendment 20 #
Proposal for a regulation – amending act
Article 1 — point 11
Article 1 — point 11
Regulation (EC) No 726/2004
Article 26 – paragraph 4 a (new)
Article 26 – paragraph 4 a (new)
(4a) the most up-to-date electronic version of the package leaflet and Summary of Product Characteristics for all existing and new medicinal products;
Amendment 21 #
Proposal for a regulation – amending act
Article 1 — point 11
Article 1 — point 11
Regulation (EC) No 726/2004
Article 26 – point 4 b (new)
Article 26 – point 4 b (new)
(4b) a brief document history of changes made to the product information. All information on the safety web-portals, including all of that set out in points 1 to 4b of this Article, shall be presented in an understandable way for the general public.
Amendment 31 #
Proposal for a regulation – amending act
Recital 15
Recital 15
(15) 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 intensivecontinuously monitored on the market. PAs with all medicines, 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’).
Amendment 42 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation EC/726/2004
Article 23 – subparagraph 1
Article 23 – subparagraph 1
The Agency shall establish and make public a list of medicinal products for human use under intensive monitoring.
Amendment 53 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation EC/726/2004
Article 26 – points 4, 4 a (new), 4 b (new)
Article 26 – points 4, 4 a (new), 4 b (new)
(4) the list of medicinal products under intensive monitoring referred to in Article 23 of this Regulation;referred to in Article 23 of this Regulation whose authorisation is subject to certain conditions or requirements; (4a) the most up-to-date electronic version of the package leaflet and summary of product characteristics for all existing and new medicinal products; (4b) a brief document history of changes made to the product information; All information on the medicines safety web-portals, including all of the above, shall be presented in a manner that is comprehensible to the general public.