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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 25 CELEX: 02007R1394-20190726 Report and review
By 30 December 2012, the Commission shall publish a general report on the application of this Regulation, which shall include comprehensive information on the different types of advanced therapy medicinal products authorised pursuant to this Regulation.
In this report, the Commission shall assess the impact of technical progress on the application of this Regulation. It shall also review the scope of this Regulation, including in particular the regulatory framework for combined advanced therapy medicinal products. |