Activities of António Fernando CORREIA DE CAMPOS 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 (6)
Amendment 4 #
Proposal for a regulation – amending act
Recital 1
Recital 1
(1) On 20 December 2007, the Commission submitted a Communication to the European Parliament and the Council concerning the "Report on current practices with regard to the provision of information to patients on medicinal products". The report concludes that Member States have adopted divergent rules and practices with regard to the provision of information, resulting in a situation where patients and the public at large have unequal access to information on medicinal products. Experience gained from the application of the current legal framework has also shown disparities in the interpretation of the Community rules on advertising, and between national provisions on information, highlighting the urgent need for a more precise distinction between advertising and information.
Amendment 5 #
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'), and for the Agency 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 6 #
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 dissemination, unless this information is given on an internet website where responsibility for monitoring the content disseminated rests with a Member State in accordance with Article 100h of Directive 2001/83/EC.
Amendment 7 #
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, stating the grounds for its decision, within 6120 days after receipt of the notification. If the Agency does not object within 6120 days, the information shall be deemed accepted and may be published.
Amendment 8 #
Proposal for a regulation – amending act
Article 1 – point 1 a (new)
Article 1 – point 1 a (new)
Regulation (EC) No 726/2004
Article 57 – paragraph 1 – point l
Article 57 – paragraph 1 – point l
(1a) In Article 57(1), point (l) shall be replaced by the following: (l) Creating a database on medicinal products, to be accessible to the general public, in all the official languages of the EU, and ensuring that it is updated, and managed independently of the commercial interests of pharmaceutical companies; the database shall facilitate the search for information already authorised for package leaflets; it shall include a section on medicinal products authorised for the treatment of children; the information provided to the public shall be worded in an appropriate and comprehensible manner, designed for the non-expert public;
Amendment 9 #
Proposal for a regulation – amending act
Article 1 – point 2 a (new)
Article 1 – point 2 a (new)
Regulation (EC) No 726/2004
Article 57 – paragraph 2
Article 57 – paragraph 2
(2a) In Article 57, paragraph 2 shall be replaced by the following: 2. The database provided for in paragraph 1(l) shall include the summaries of product characteristics, the patient or user package leaflet and the information shown on the labelling. The database shall be developed in stages, priority being given to medicinal products authorised under this Regulation and those authorised under Chapter 4 of Title III of Directive 2001/83/EC and of Directive 2001/82/EC respectively. The database shall subsequently be extended to include any medicinal product placed on the market within the Community. Where appropriate, the database shall also include references to data on clinical trials currently being carried out or already completed, contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC. The Commission shall, in consultation with the Member States, issue guidelines on data fields which could be included and which may be accessible to the public. This database shall be actively promoted to European citizens. The information submitted by holders of marketing authorisation and approved by the national authorities shall be sent to the Agency by those authorities and included in its database available to the public.