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Regulation (EC) No 1394/2007 of the European Parliament and of the CouncilDangos y teitl llawn
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 726/2004 (Text with EEA relevance)
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CHAPTER 6U.K.INCENTIVES
Article 16U.K.Scientific advice
1.The applicant or holder of a marketing authorisation may request advice from the Agency on the design and conduct of pharmacovigilance and of the risk management system referred to in Article 14.
2.By way of derogation from Article 8(1) of Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products(1), a 90 % reduction for small and medium-sized enterprises and 65 % for other applicants shall apply to the fee for scientific advice payable to the Agency for any advice given in respect of advanced therapy medicinal products pursuant to paragraph 1 of this Article and Article 57(1)(n) of Regulation (EC) No 726/2004.
Article 17U.K.Scientific recommendation on advanced therapy classification
1.Any applicant developing a product based on genes, cells or tissues may request a scientific recommendation of the Agency with a view to determining whether the referred product falls, on scientific grounds, within the definition of an advanced therapy medicinal product. The Agency shall deliver this recommendation after consultation with the Commission and within 60 days after receipt of the request.
2.The Agency shall publish summaries of the recommendations delivered in accordance with paragraph 1, after deletion of all information of commercial confidential nature.
Article 18U.K.Certification of quality and non-clinical data
Small and medium-sized enterprises developing an advanced therapy medicinal product may submit to the Agency all relevant quality and, where available, non-clinical data required in accordance with modules 3 and 4 of Annex I to Directive 2001/83/EC, for scientific evaluation and certification.
The Commission shall lay down provisions for the evaluation and certification of such data, in accordance with the regulatory procedure referred to in Article 26(2).
Article 19U.K.Reduction of the fee for marketing authorisation
1.By way of derogation from Regulation (EC) No 297/95, the fee for marketing authorisation shall be reduced by 50 % if the applicant is a hospital or a small or medium-sized enterprise and can prove that there is a particular public health interest in the Community in the advanced therapy medicinal product concerned.
2.Paragraph 1 shall also apply to fees charged by the Agency for post-authorisation activities in the first year following the granting of the marketing authorisation for the advanced therapy medicinal product.
3.Paragraphs 1 and 2 shall apply during the transitional periods laid down in Article 29.
(1)
OJ L 35, 15.2.1995, p. 1. Regulation as last amended by Regulation (EC) No 1905/2005 (OJ L 304, 23.11.2005, p. 1).
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