Activities of Antonyia PARVANOVA 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)
Shadow opinions (1)
OPINION Proposal for a regulation of the European Parliament and of the Council amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
Amendments (9)
Amendment 24 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation (EC) No 726/2004
Article 26 – paragraph 1 a (new)
Article 26 – paragraph 1 a (new)
Before the launch of this portal, the Agency consults relevant stakeholders (including patient groups, healthcare professionals and industry representatives) to get their opinion.
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 38 #
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.
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 44 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation EC/726/2004
Article 24 – paragraph 2 – subparagraph 1
Article 24 – paragraph 2 – subparagraph 1
2. The Eudravigilance database shall be fully accessible to the competent authorities of the Member States and to the Agency and the Commission. It shall also be accessible to marketing authorisation holders to the extent necessary for them to comply with their pharmacovigilance obligations. The Agency shall work together with all stakeholders, including research institutions, health professionals, patients and consumer organisations, in order to define the "appropriate level of access" to the Eudravigilance database.
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 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.