Activities of Ashley FOX related to 2008/0255(COD)
Shadow opinions (1)
OPINION Proposal for a regulation of the European Parliament and of the Council amending, as regards information to the general public on medicinal products for human use subject to medical prescription, 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 (2)
Amendment 9 #
Proposal for a regulation – amending act
Recital 4
Recital 4
(4) Directive 2001/83/EC provides that certain types of information are subject to control by the Member States' national competent authorities prior to their dissemination. This concerns information about non-interventional scientific studies based on experimental observation, or accompanying measures to prevention and medical treatment, or information which presents the medicinal product in the context of the condition to be prevented or treated. In the case of medicinal products for human use authorised pursuant to Title II of Regulation (EC) No 726/2004, provision should also be made for certain types of information to be subject to prior vetting by the European Medicines Agency (hereinafter referred to as the 'Agency'), unless the content of that information had already been vetted by a competent national authority, and for the Agency, or a competent national body, to monitor the measures to be taken by the manufacturer following a report of adverse reactions, and the consequent immediate updating of the literature.
Amendment 12 #
Proposal for a regulation – amending act
Article 1 – point 1
Article 1 – point 1
Regulation (EC) No 726/2004
Article 20b – paragraph 1
Article 20b – paragraph 1
1. By way of derogation from Article 100g(1) of Directive 2001/83/EC, medicinal product-related information referred to in Article 100b(d) of that Directive shall be subject to vetting by the Agency or a competent national authority prior to its dissemination.