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Division 3.2.1.4 Control of active substance(s)F1

United Kingdom

Original text. Later amendments are not shown.

Detailed information on the specifications used for routine control of active substance(s), justification for the choice of these specifications, methods of analysis and their validation shall be provided.

The results of control carried out on individual batches manufactured during development shall be presented.

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).