Regulation 2007/658 - Financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation 726/2004 - Main contents
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official title
Commission Regulation (EC) No 658/2007 of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council| Legal instrument | Regulation |
|---|---|
| Number legal act | Regulation 2007/658 |
| CELEX number i | 32007R0658 |
| Document | 14-06-2007 |
|---|---|
| Publication in Official Journal | 15-06-2007; Special edition in Croatian: Chapter 13 Volume 064,OJ L 155, 15.6.2007 |
| Effect | 05-07-2007; Entry into force Date pub. + 20 See Art 28 |
| End of validity | 31-12-9999 |
15.6.2007 |
EN |
Official Journal of the European Union |
L 155/10 |
COMMISSION REGULATION (EC) No 658/2007
of 14 June 2007
concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to 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 (1), and in particular the first subparagraph of Article 84(3) thereof,
Whereas:
(1) |
In order to ensure the enforcement of certain obligations connected with marketing authorisations for medicinal products granted in accordance with Regulation (EC) No 726/2004, Article 84 of that Regulation empowers the Commission, at the request of the European Medicines Agency, hereinafter ‘the Agency’, to impose financial penalties on the holders of marketing authorisations. |
(2) |
Infringements of obligations laid down in connection with marketing authorisations granted in accordance with Regulation (EC) No 726/2004 which may lead to the application of a financial penalty should concern the content of a marketing authorisation and post-marketing requirements linked to a marketing authorisation, including the requirements of Community law relating to pharmacovigilance and market surveillance. |
(3) |
Moreover, in view of the provision made by Article 84(1) of Regulation (EC) No 726/2004, under which the Member States are to determine the penalties to be applied for infringement of the provisions of that Regulation or the Regulations adopted pursuant to it and to take the necessary measures for their implementation, action at Community level should be taken only in cases where the interests of the Community are involved. In that way, the effective enforcement of Regulation (EC) No 726/2004 would be ensured by an appropriate management of the resources available at Community and national level. |
(4) |
As a result of the system of parallel powers in relation to supervision and enforcement by the Community and the Member States with regard to marketing authorisations granted in accordance with Regulation (EC) No 726/2004, the provisions of this Regulation can be effectively enforced only in a framework of close cooperation, in accordance with Article 10 of the Treaty, between the Member States, the Agency and the Commission. For that purpose it is necessary to set up arrangements for consultation and cooperation between them. |
(5) |
It is appropriate that, for the purposes of the initiation and conduct of the infringement procedure and the quantification of financial penalties, the Agency and the Commission should take into account any procedure by a Member State against the same marketing authorisation holder and based on the same legal grounds and the same facts. |
(6) |
In order to ensure the effective conduct of the inquiry stage of alleged infringements, the Agency and the Commission should have recourse to the competent authorities of the Member States, designated as the supervisory authorities of medicinal products authorised through the centralised procedure by Regulation (EC) No 726/2004, to carry out the necessary measures of inquiry and to obtain information relating to infringements falling within the scope of this Regulation. To that end, it is appropriate that the supervisory authorities conduct the inspection and surveillance activities for which they are competent in accordance with the provisions of Regulation (EC) No 726/2004, Directive 2001/82/EC of the European... |
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