# Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, Division 3.2.1.4: Control of active substance(s)

Extent: E+W+S+N.I.

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.

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Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/I/division/3/division/3.2/division/3.2.1/division/3.2.1.4 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-I/division-3/division-3.2/division-3.2.1/division-3.2.1.4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.