Considerations on COM(2012)49 - Amendment of Regulation (EC) No 726/2004 as regards information to the general public on medicinal products for human use subject to medical prescription - Main contents
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dossier | COM(2012)49 - Amendment of Regulation (EC) No 726/2004 as regards information to the general public on medicinal products for human use ... |
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document | COM(2012)49 |
date | February 10, 2012 |
(2) The introduction of a new Title VIIIa in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on a Community code relating to medicinal products for human use[6] addresses those concerns through various provisions intended to ensure the availability of good-quality, objective, reliable and non promotional information on medicinal products for human use subject to prescription and to place emphasis on the rights and interests of patients.
(3) Disparities in the provision of information on medicinal products for human use are not justified in the case of medicinal products authorised pursuant to Title II of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency[7] for which a single summary of the products characteristics and package leaflet are approved for the whole CommunityUnion. Therefore Title VIIIa of Directive 2001/83/EC should also apply to those products.
(4) Directive 2001/83/EC provides, with some exceptions, that certain types of information are is subject to control by the Member States' national competent authorities prior to their dissemination being 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 this information to be subject to prior vetting by the European Medicines Agency (hereinafter referred to as the Agency), and to clarify the operation of the control mechanism in the case of information made available through Internet websites registered with the Member States in accordance with Directive 2001/83/EC.
(5) To ensure the adequate funding of these activities related to information, provision should be made for the collection of fees charged to marketing authorisation holders by the Agency.
(6) Information on medicinal products is already provided at Union level by several databases and portals managed by the Agency or the Commission concerning inter alia medicinal products and clinical trials, such as the Orphanet portal for rare diseases and orphan drugs[8]. It is appropriate to link these different sources of information to facilitate access by the public. The European medicines web portal created by Regulation (EC) No 726/2004, as amended by Regulation (EU) No 1235/2010[9], should be the single point of reference for access to that information.
(7) As the prior vetting of information by the Agency will be financed by applicants' fees which are to be adjusted, it is appropriate to provide for a deferred application of the provisions on the pre-vetting of information by the Agency.
(8) Since the objective of this Regulation, namely to provide for specific rules on information on medicinal products for human use subject to prescription authorised pursuant to Regulation (EC) No 726/2004 cannot be sufficiently achieved by Member States and can be better achieved at CommunityUnion level, the CommunityUnion may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve this objective.
(9) Regulation (EC) No 726/2004 should therefore be amended accordingly.