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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) article 19 CELEX: 02007R1394-20190726 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. |