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Division 5.3.3 Safety studiesF1F2

United Kingdom

Original text. Later amendments are not shown.

Safety studies shall address the following aspects:

  1. (a)

    distribution and engrafting following administration;

  2. (b)

    ectopic engraftment;

  3. (c)

    oncogenic transformation and cell/tissue lineage fidelity.

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).