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REGULATORY REFERENCES

European Advanced Therapy Medicinal Products (ATMP) Regulation

OFFICIAL VERSION

The official version of the Regulation on Advanced Therapy Medicinal Products (ATMP) was published in the Official Journal of the European Communities on 10 December 2007, having been adopted by the European Parliament and Council on 13 November 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 will take effect on 30 December 2007, with implementation in member states from 30 December 2008.  Transitional periods will apply for products already on the market that will fall into the scope of the regulation, as follows:

  • 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, shall comply with this Regulation no later than 30 December 2011.
  • Tissue engineered products which were legally on the Community market in accordance with national or Community legislation on 30 December 2008 shall comply with this Regulation no later than 30 December 2012.

Manufacturers of products not covered by other legislation by 30 December 2008 will have to comply with the regulation's requirements from that date.

A copy of the ATMP Regulation, as published in the OJ, can be accessed here.


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