# Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, Division 1: Active substances(s)

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

A retest period and storage conditions for the active substance shall be specified except in the case where the active substance is the subject of a monograph in the European Pharmacopoeia and the manufacturer of the finished product fully retests the active substance immediately before its use in the manufacture of the finished product.
Stability data shall be presented to support the defined retest period and storage conditions. The type of stability studies conducted, protocols used, the analytical procedures used and their validation together with the detailed results shall be presented. The stability commitment with a summary of the protocol shall be provided.
However, where a Certificate of Suitability for the active substance from the proposed source is available and specifies a retest period and storage conditions, stability data for the active substance from that source are not required.

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Source: https://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/F/division/1 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-82/annex-I/title-I/part-2/division-F/division-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.