Activities of Anne DELVAUX related to 2008/0257(COD)
Plenary speeches (2)
Explanations of vote
Explanations of vote
Amendments (5)
Amendment 21 #
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 28 #
Proposal for a regulation – amending act
Recital 11
Recital 11
(11) In order to protect public health, there should be adequate funding of activities related to pharmacovigilance by the Agency. Provision should be made to allow adequate funding for pharmacovigilance activities through the collection of fees charged to marketing authorisation holders. The management of those collected funds should be under a permanent control of the Management Board in order to guarantee the independence ofing to pharmacovigilance by the Agency.
Amendment 29 #
Proposal for a regulation – amending act
Recital 15
Recital 15
(15) WFor any new authorised medicinal product on the market for less then 3 years or 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 intensively monitored on the market. Patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products, identified by a black triangle and a corresponding explanatory sentence on the summary of product characteristics, and on the patient information leaflet, and a publicly available list of such medicinal products should be kept up to date by the Agency.
Amendment 46 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation EC/726/2004
Article 24 – paragraph 2 – subparagraphs 2 and 3
Article 24 – paragraph 2 – subparagraphs 2 and 3
The Agency shall ensure that health-care professionals and the public have appropriate levels of access to the Eudravigilance database, with personal data protection being guaranteed. The Agency shall work together with organisations representing health professionals, patients and consumers to define “the appropriate level of access”. The data held on the Eudravigilance database shall be made publicly accessible in an aggregated format together with an explanation of how to interpret the data.
Amendment 80 #
Proposal for a regulation – amending act
Article 1 – point 18 – point b
Article 1 – point 18 – point b
Regulation EC/726/2004
Article 67 – paragraph 4
Article 67 – paragraph 4
"4. Activities relating to pharmacovigilance, to the operation of communications networks and to market surveillance shall be under the permanent control of the Management Board in order to guarantee the independence of the Agency. Thisey shall not preclude the collection of fees to be paid by marketing authorisation holders for the carrying out of these activities by the Agencyreceive adequate public funding commensurate with the tasks conferred."