Activities of Pilar AYUSO 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 37 #
Proposal for a regulation – amending act
Article 1 – point 4
Article 1 – point 4
Regulation EC/726/2004
Article 10a – paragraph 1
Article 10a – paragraph 1
1. After the granting of a marketing authorisation, the Agency may require a marketing authorisation holder to conduct a post-authorisation safety study if there are concerns about the risks of an authorised medicinal product. The requirement shall be made in writing, provide a detailed justification on the basis of scientific arguments and include the objectives and timeframe for submission and conduct of the study.
Amendment 39 #
Proposal for a regulation – amending act
Article 1 – point 5 b
Article 1 – point 5 b
Regulation EC/726/2004
Article 14 – paragraph 3
Article 14 – paragraph 3
3. Once renewed, the marketing authorisation shall be valid for an unlimited period, unless the national competent authority decides, on justified grounds relating to pharmacovigilance or to insufficient exposure to the product, to proceed with one additional five-year renewal in accordance with paragraph 2.”
Amendment 41 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation EC/726/2004
Article 21 – paragraph 2 – subparagraph 2
Article 21 – paragraph 2 – subparagraph 2
The requirement shall be made in writing, provide a detailed justification, on the basis of scientific arguments and include the timeframe for submission of the detailed description of the risk- management system.
Amendment 48 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation EC/726/2004
Article 25
Article 25
The Agency, in collaboration with the Member States, shall develop standard web-based structur and all relevant stakeholders, shall develop standard structured forms and procedures, including web-based forms, for the reporting of suspected adverse reactions by health-care professionals and patients. To ensure the traceability of biological medicinal products prescribed, dispensed or sold in the territory of the Union the standard forms and procedures shall include the name of the MAH, the INN, the name of the medicinal product as defined in Article 1(2) and the batch number.
Amendment 56 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation EC/726/2004
Article 26 – paragraph 10 a (new)
Article 26 – paragraph 10 a (new)
(10a) Before the launch of this portal, the Agency consults relevant stakeholders (including patient groups, healthcare professionals and industry representatives) to get their opinion.
Amendment 64 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation EC/726/2004
Article 28 – paragraph 6
Article 28 – paragraph 6
6. The final opinions and final decisions referred to in paragraphs 3 to 5 of this Article shall be made public by means of the European medicines safety web-portal referred to in Article 26.
Amendment 71 #
Proposal for a regulation – amending act
Article 1 – point 13 – point b
Article 1 – point 13 – point b
Regulation EC/726/2004
Article 57 – paragraph 2 – point b
Article 57 – paragraph 2 – point b
(b) marketing authorisation holders shall, by -/- (insert date - eighteenthirty months after the entry into force of the amending regulation) at the latest, electronically submit to the Agency information for all medicinal products authorised or registered in the Community, using the format referred to in point (a);
Amendment 86 #
Proposal for a regulation – amending act
Article 2 – paragraph 1
Article 2 – paragraph 1
1. The requirement for the inclusion of a summary of the essential information necessary to use the medicine safely and effectively in the summary of the product characteristics and the package leaflet provided for in point 3a of Article 11 and in point (aa) of Article 59(1) of Directive 2001/83/EC as amended by Directive …/…/EC, which applies to medicinal products authorised pursuant to Regulation (EC) No 726/2004 by virtue of its Article 9(4)(a) and (d), shall apply to a marketing authorisation granted before the date set out in the second paragraph of Article 3 of this Regulation from renewal of that authorisation or from the expiry of a period of three years starting from that date, whichever is the earliest.