3 Amendments of Andrés PERELLÓ RODRÍGUEZ related to 2008/0260(COD)
Amendment 168 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 101 – paragraph 2
Article 101 – paragraph 2
2. Member States shall by means of the pharmacovigilance system referred to in paragraph 1 evaluate all information scientifically, consider options for risk minimisation and prevention and take regulatory action as necessary. To that end they shall also obtain the relevant information concerning use of the medication so as to assess the impact of the risks on public health. They shall perform a regular audit of their pharmacovigilance system and report the results to the Commission on [insert concrete date - two-years after the date of transposition referred to in Article 3(1)] at the latest and then every two years thereafter.
Amendment 257 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 n – paragraph 1
Article 107 n – paragraph 1
1. This Chaptee procedures laid down in Articles 107o to 107r shall apply to non- interventional post-authorisation safety studies which are initiated, managed or financed by the marketing authorisation holder, voluntarily or following a requirement in accordance with Articles 21a or 22a, and which involve the collection of data from patients or health- care professionals.
Amendment 270 #
Proposal for a directive – amending act
Article 1 – point 28
Article 1 – point 28
Directive 2001/83/EC
Article 2 a (new)
Article 2 a (new)
Article 2a Transitional provision 1. With regard to the requirement for the marketing authorisation holder to submit information on adverse reactions electronically to the Eudravigilance database, laid down in Article 107(3) of the present Directive, Member States shall ensure that the said requirement is applied once the functionalities of the database make it possible to provide information on adverse reactions that is complete and of proper quality and includes essential health data, codified data on the medicinal products, proper differentiation of follow-up reports and the elimination of duplicate cases. 2. The Agency’s Management Board shall confirm, on the basis of an independent inquiry, that the functionalities referred to in paragraph 1 are operational.