Commission Regulation (EC) No 668/2009 of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by micro, small and medium-sized enterprises (Text with EEA relevance)
Commission Regulation (EC) No 668/2009of 24 July 2009implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by micro, small and medium-sized enterprises(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004OJ L 324, 10.12.2007, p. 121., and in particular Article 18 thereof,Whereas:(1)It is appropriate, in the framework of Regulation (EC) No 1394/2007, to lay down provisions for the evaluation and certification of quality and non-clinical data submitted by small and medium-sized enterprises to the European Medicines Agency (hereinafter the Agency) in order to give those enterprises an incentive to conduct quality and non-clinical studies on advanced therapy medicinal products.(2)For reasons of coherence and transparency, the definition of micro, small and medium-sized enterprises provided for in Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprisesOJ L 124, 20.5.2003, p. 36. should apply.(3)Pursuant to Regulation (EC) No 1394/2007, the certification procedure should be independent from any application for marketing authorisation. Nevertheless, it should also aim at facilitating the evaluation of any future application for clinical trial and marketing authorisation based on the same data. For this reason, the evaluation of an application for certification should be conducted in accordance with the same scientific and technical requirements as those applicable to a marketing authorisation application, as laid down in Annex I to 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 useOJ L 311, 28.11.2001, p. 67..(4)It should be possible for applicants for certification to provide all or parts of quality and non-clinical data required by Annex I to Directive 2001/83/EC. However, in order to ensure the added value of certifications, it is appropriate to lay down a minimum set of data required for certification.(5)Within the Agency, the Committee for Advanced Therapies has the appropriate expertise for the examination of quality and non-clinical data relating to advanced therapy medicinal products. It should therefore be responsible for evaluating applications for certification.(6)Where necessary, it should be possible for the Committee for Advanced Therapies to make completion of its evaluation subject to a site visit of the premises where the advanced therapy medicinal product is being developed.(7)Applications for certification may relate to combined advanced therapy medicinal products within the meaning of Regulation (EC) No 1394/2007. In such a case, additional requirements should apply in relation to the conformity of the medical device or active implantable medical device contained in the combined product with the essential requirements laid down in Council Directive 93/42/EEC of 14 June 1993 concerning medical devicesOJ L 169, 12.7.1993, p. 1. and Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devicesOJ L 189, 20.7.1990, p. 17., respectively.(8)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee for Medicinal Products for Human Use,HAS ADOPTED THIS REGULATION: