6 Amendments of Ashley FOX related to 2008/0257(COD)
Amendment 16 #
Proposal for a regulation – amending act
Article 1 — point 11
Article 1 — point 11
Regulation (EC) No 726/2004
Article 26 — point 3
Article 26 — point 3
(3) a summary of risk management systems for medicinal products authorised in accordance with this Regulation;
Amendment 17 #
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 19 #
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 22 #
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;
Amendment 23 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation (EC) No 726/2004
Article 26 – point 10
Article 26 – point 10
(10) Assessment conclusions, recommendations, opinions and decisions taken by the committees referred to in points (a) and (aa) of Article 56(1) of this Regulation and the coordination group, the national competent authorities and the Commission in the framework of the procedures of Articles 28, 28a and 28b of this Regulation and of sections 2 and 3 of Chapter 3 of Title IX of Directive 2001/83/EC. All information of the safety web-portal, including all of the information set out in points 1 to 10 of this Article shall be presented in an understandable way for the general public. Information on safety and potential risks of a medicinal product shall be provided in the context of the overall proven benefits.
Amendment 25 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation (EC) No 726/2004
Article 27 – paragraphs 1 and 2
Article 27 – paragraphs 1 and 2
1. The Agency shall monitor selectedthe medical literature for reports of suspected adverse reactions to medicinal products for human use containing certain active substances. It shall publish the list of active substances being monitored and the publications subject to this monitoring. 2. The Agency shall enter into the Eudravigilance database relevant information from the selected literature.