Commission Regulation (EU) No 488/2012Show full title

F1 Commission Regulation (EU) No 488/2012

of 8 June 2012

amending Regulation (EC) No 658/2007 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 EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

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,

Having regard to Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004(2), and in particular Article 49(3) thereof,

Whereas:

(1) Regulation (EU) No 1235/2010 of the European Parliament and of the Council(3) amended Regulation (EC) No 726/2004 as regards pharmacovigilance of medicinal products for human use in order to strengthen and rationalise the monitoring of the safety of medicines that have been placed on the market in the Union. The provisions of Regulation (EC) No 726/2004 are complemented by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(4) which has been amended by Directive 2010/84/EU of the European Parliament and of the Council(5) as regards pharmacovigilance. In order to ensure the enforcement of the obligations relating to pharmacovigilance introduced by Regulation (EU) No 1235/2010 and Directive 2010/84/EU, it is necessary to adapt 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(6) so that any infringement of those obligations may be subject to the financial penalties provided for in Regulation (EC) No 658/2007.

(2) Regulation (EC) No 1901/2006, as amended by Regulation (EC) No 1902/2006(7), provides that the Commission may impose financial penalties for infringement of its provisions or the implementing measures adopted pursuant to it in relation to medicinal products authorised through the procedure laid down in Regulation (EC) No 726/2004. It also empowers the Commission to adopt measures concerning the maximum amounts of those penalties and the conditions and methods for their collection. Since Regulation (EC) No 658/2007 concerns financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004, it is appropriate, for reasons of consistency, to include in the scope of Regulation (EC) No 658/2007 the obligations provided for in Regulation (EC) No 1901/2006 whose infringement may give rise to financial penalties under that same Regulation.

(3) In view of the harmonised application of the obligations laid down in connection with marketing authorisations granted under Regulation (EC) No 726/2004 and of the need to ensure the effectiveness of those obligations, the interests of the Union are involved where those obligations are infringed. Moreover, pharmacovigilance rules are necessary for the protection of public health in order to prevent, detect and assess adverse reactions to medicinal products for human use placed on the Union market, as the full safety profile of medicinal products for human use can be known only after they have been placed on the market.

(4) Infringements in relation to veterinary medicinal products are not concerned by Regulation (EC) No 1901/2006 or the amendments as regards pharmacovigilance. The scope of Regulation (EC) No 658/2007 therefore does not need to be modified in this respect. However, in order to ensure consistency with the amended provisions and to improve clarity, it is appropriate to restructure certain provisions concerning veterinary medicinal products without altering the substance.

(5) The amended provisions shall apply as of the same date as the amendments by Regulation (EU) No 1235/2010 as regards pharmacovigilance.

(6) Regulation (EC) No 658/2007 should therefore be amended accordingly.

(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee for Medicinal Products for Human Use and the Standing Committee for Veterinary Medicinal Products,

HAS ADOPTED THIS REGULATION:

Textual Amendments

F1 Regulation revoked in part (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(s) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)

(1)

OJ L 136, 30.4.2004, p. 1.

(2)

OJ L 378, 27.12.2006, p. 1.

(3)

OJ L 348, 31.12.2010, p. 1.

(4)

OJ L 311, 28.11.2001, p. 67.

(5)

OJ L 348, 31.12.2010, p. 74.

(6)

OJ L 155, 15.6.2007, p. 10.

(7)

OJ L 378, 27.12.2006, p. 20.