Activities of Jiří MAŠTÁLKA 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 (9)
Amendment 17 #
Proposal for a regulation – amending act
Recital 4
Recital 4
(4) The main tasks of the Agency in the area of pharmacovigilance laid down in Regulation (EC) No 726/2004 should be maintained and further developed, in particular as regards the management of the Community pharmacovigilance database and data-processing network (hereinafter referred to as 'the Eudravigilance database') and, the coordination of safety announcements by the Member States. and the provision of information regarding safety issues to the public. Or. en Justification
Amendment 18 #
Proposal for a regulation – amending act
Recital 5
Recital 5
(5) In order to allow all competent authorities to receive and access, at the same time, pharmacovigilance information for medicinal products for human use authorised in the CommunityUnion, and share it, the Eudravigilance database should be maintained and strengthened as the single point of receipt of such information. Member States should therefore not impose on marketing authorisation holders any additional reporting requirements. Instead, the Eudravigilance database should simultaneously notify the relevant Member States of reports submitted by market authorisation holders. In order to ensure the high quality of information, Member States should support the development of national and regional pharmacovigilance centres' expertise. National competent authorities should collect the reports from these centres and should then transfer data to Eudravigilance database. The database should be fully accessible to the Member States, the Agency and the Commission, and accessible to an appropriate extent to marketing authorisation holders and the public.
Amendment 26 #
Proposal for a regulation – amending act
Recital 11
Recital 11
Amendment 43 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation EC/726/2004
Article 24 – paragraph 2 – subparagraphs 3 a (new)
Article 24 – paragraph 2 – subparagraphs 3 a (new)
The Agency shall work together with organisations representing health professionals, patients and consumers to define “the appropriate level of access”.
Amendment 50 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation EC/726/2004
Article 26 – point 2
Article 26 – point 2
(2) a summary of each meetinggendas for meetings, records of meetings, accompanied by decisions taken, details of votes and explanations of votes, including minority opinions of the committees referred to in points (a) and (aa) of Article 56(1) of this Regulation and the coordination group as regards pharmacovigilance activities;
Amendment 52 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation EC/726/2004
Article 26 – point 3
Article 26 – point 3
(3) risk management systems for medicinal products authorised in accordance with this Regulation, with an explanation of how to operate them;
Amendment 54 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation EC/726/2004
Article 26 – point 6
Article 26 – point 6
(6) information about how to report suspected adverse reactions to medicinal products and standard forms for their web- based reporting by patients and health-care professionals;
Amendment 55 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation EC/726/2004
Article 26 – point 8
Article 26 – point 8
(8) a synopsis of protocols and public abstracts of results as regards post authorisation safety studies conducted in more than one Member State and referred to in Articles 107o and 107q of Directive 2001/83/EC;
Amendment 57 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation EC/726/2004
Article 27 – paragraph 1
Article 27 – paragraph 1
1. The Agency shall monitor selected 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. The Agency shall monitor all medical literature for reports of suspected adverse reactions to medicinal products for human use containing well-established active substances.