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Division 3.3.2 Specific requirementsF1F2

United Kingdom

Original text. Later amendments are not shown.

In addition to the requirements set out in sections 3.2.1 and 3.2.2 of Part I of this Annex, the following requirements shall apply:

  1. 3.3.2.1Starting materials
  2. 3.3.2.2Manufacturing process
  3. 3.3.2.3Characterisation and control strategy
  4. 3.3.2.4Excipients
  5. 3.3.2.5Developmental studies
  6. 3.3.2.6Reference materials

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).