3 Amendments of Patrizia TOIA related to 2008/0257(COD)
Amendment 16 #
Proposal for a regulation – amending act
Recital 7
Recital 7
(7) In order to ensure the availability of the necessary expertise and resources for pharmacovigilance assessments at Community level, it is appropriate to create a new scientific committee within the Agency, the Pharmacovigilance Risk Assessment Advisory Committee. That committee should be composed of independent scientific experts with competence in the safety of medicines including the detection, assessment, minimisation and communication of risk, and the design of post-authorisation safety studies and pharmacovigilance audit. The scientific experts serving on the committee should be independent both in relation to authorisation holders and in relation to the Agency itself, especially when safety studies are being conducted on medicines.
Amendment 17 #
Proposal for a regulation – amending act
Recital 15
Recital 15
(15) WFor three years following the placing on the market of a newly authorised medicinal product or where a medicinal product is authorizsed 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, which should be labelled with a black triangle and a corresponding explanatory sentence summarising the product characteristics, which should be displayed on the patient information leaflet, and a publicly available list of such medicinal products should be kept up to date by the Agency.
Amendment 22 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation (EC) No 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 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.