Avrupa Birliği Ceza Düzenlemesi genişletildi (İng)


EU Penalties Regulation 658/2007 has been extended and now empowers the European Commission to impose financial penalties on MAHs in relation to the infringement of pharmacovigilance obligations

As of 2 July 2012 the scope of the EU Penalties Regulation 658/2007 has been extended and now empowers the European Commission to impose financial penalties on marketing authorisation holders (MAH) also in relation to the infringement of certain pharmacovigilance and paediatric obligations following an amendment of the Penalties Regulation by Commission Regulation 488/2012.

The Penalties Regulation concerns only centrally authorised medicinal products. In this regard, the Commission is entitled to inflict penalties on MAHs for infringing obligations which are enumerated in Article 1 of the amended wording. This revised list contains 28 obligations, inter alia, the completeness and accuracy of data contained in the application for marketing authorisation and any updating of them, the compliance with conditions or restrictions included in the MA, and the pharmacovigilance and post-marketing surveillance (such as PASS, PAES). To keep in line with the amended version of Regulation 658/2007 pharma companies should in particular ensure:

•       the operation of a comprehensive pharmacovigilance system, including the operation of a quality system, maintenance of the pharmacovigilance system master file and performance of regular audits, Article 1 (11);
•       the operation of a risk management system, Article 1 (12);
•       that public announcements relating to information on pharmacovigilance concerns are presented objectively, are not misleading and to notify them to the EMA, Article 1 (23);
•       the submission of paediatric studies to the EMA, including the obligation to enter information into the European database on third country clinical trials, Article 1 (27);
•       the submission of an annual report to EMA providing an update on progress with paediatric studies, Article 1 (28).

Where, after an infringement procedure has been initiated by the EMA, the Commission finds that the MAH has committed, intentionally or negligently, an infringement of the obligations as referred to in Article 1, it may adopt a decision imposing a maximum fine of 5 % of the holder’s Community turnover in the preceding business year.
Whereas under the old regime no financial penalties have been imposed by the Commission, the EMA has announced on 23 October 2012 that it started infringement proceedings to investigate allegations that Roche Registration Ltd. has failed to comply with pharmacovigilance obligations in relation to its 19 centrally authorized medicinal products (http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2012/10/WC500134176.pdf).

The start of this procedure demonstrates that with the extension of the scope of Regulation 658/2007 the risk to be subject to the considerable fines provided for in the Regulation has significantly increased. Therefore, it is crucial that MAHs pay special attention to the relevant obligations included in Regulation 726/2004 on centrally authorised medicinal products and Regulation 1901/2006 on medicinal products for paediatric use.