Activities of Anja WEISGERBER related to 2008/0255(COD)
Plenary speeches (1)
Information on medicinal products (Community code relating to medicinal products) - Information on medicinal products (Community procedures for the authorisation and supervision of medicinal products) (debate)
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 (4)
Amendment 10 #
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 disseminationbeing made available. This concerns information about non-interventional scientific studies, 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').
Amendment 13 #
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 prior to its disseminationbeing made available.
Amendment 14 #
Proposal for a regulation – amending act
Article 1 – point 1
Article 1 – point 1
Regulation (EC) No 726/2004
Article 20b – paragraph 2
Article 20b – paragraph 2
2. For the purposes of paragraph 1, the marketing authorisation holder shall submit to the Agency a mock-up of the information to be disseminatedmade available.
Amendment 15 #
Proposal for a regulation – amending act
Article 1 – point 1
Article 1 – point 1
Regulation (EC) No 726/2004
Article 20b – paragraph 3
Article 20b – paragraph 3
3. The Agency may object to the information submitted or parts thereof on grounds related to non-compliance with the provisions of Title VIIIa of Directive 2001/83/EC within 60 days after receipt of the notification. If the Agency does not object within 60 days, the information shall be deemed accepted and may be published.