Considerations on COM(2011)632 - Amendment of Regulation (EC) No 726/2004 as regards information to the general public on medicinal products for human use subject to medical prescription and as regards pharmacovigilance

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dossier COM(2011)632 - Amendment of Regulation (EC) No 726/2004 as regards information to the general public on medicinal products for human use ...
document COM(2011)632 EN
date October 11, 2011
 
(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' [5] . 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 Union rules on advertising, and between national provisions on information, highlighting the need for a more precise distinction between advertising and information.

(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 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 Union. Therefore Title VIIIa of Directive 2001/83/EC should also apply to those products.

(4) Directive 2001/83/EC provides, with some exceptions, that information is subject to control by the Member States' national competent authorities prior to being made available. In the case of medicinal products for human use authorised pursuant to Title II of Regulation (EC) No 726/2004, provision should be made for 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) In order to ensure transparency on the surveillance of authorised medicinal products, the list of medicinal products subject to additional monitoring established by Regulation (EC) No 726/2004, as amended by Regulation (EU) No 1235/2010 of the European Parliament and of the Council should systematically include medicinal products that are subject to post-authorisation safety conditions.

(7) 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 should be the single point of reference for access to that information.

(8) 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.

(9) 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 Union level, the Union 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.

(10) Regulation (EC) No 726/2004 should therefore be amended accordingly.