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EU ATMPs
European Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products (ATMP) was published in the Official Journal of the European Communities (OJ) in December 2007. The regulation covers cell therapy, gene therapy and tissue-engineered products (TEPs), including non-viable TEPs where the tissue has a primary (rather than ancillary) action.
The regulation took effect on 30 December 2007, with implementation in European member states from 30 December 2008. As a Regulation, there is no requirement for transposition into member state national law, so the Regulation text, as written, applies in all applicable countries. Transitional periods apply for products already on the market that fall within the scope of the regulation, as follows:
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Advanced therapy medicinal products, other than tissue engineered products, which were legally on the Community market in accordance with national or Community legislation on 30 December 2008, must comply with the Regulation no later than 30 December 2011.
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Tissue engineered products, which were legally on the Community market in accordance with national or Community legislation on 30 December 2008, must comply with the Regulation no later than 30 December 2012.
Manufacturers of products not covered by such prior legislation by 30 December 2008 must comply with the Regulation from that date. A copy of the ATMP Regulation, as published in the OJ, can be accessed here.
Donawa Lifescience Consulting can help identify whether products fall within the scope of the Regulation, and if so, assist with authorization in compliance with the Regulation.
Please contact us for assistance on the ATMP Regulation and how it may apply to your products.
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