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Division 5.3 Specific requirements for somatic cell therapy medicinal productsF1F2

United Kingdom

Original text. Later amendments are not shown.

  1. 5.3.1Somatic cell therapy medicinal products where the mode of action is based on the production of defined active biomolecule(s)
  2. 5.3.2Biodistribution, persistence and long-term engraftment of the somatic cell therapy medicinal product components
  3. 5.3.3Safety studies

Annotations

Textual amendments

F1

Substituted by Commission directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (Text with EEA relevance).

F2

Substituted by Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products (Text with EEA relevance).