# 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, Article 13b

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

In the case of veterinary medicinal products containing active substances used in the composition of authorised veterinary medicinal products but not hitherto used in combination for therapeutic purposes, the results of safety and residue tests, if necessary, and new pre-clinical tests or new clinical trials relating to that combination shall be provided in accordance with point (j) of the first subparagraph of Article 12(3), but it shall not be necessary to provide scientific references relating to each individual active substance.

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Source: https://www.legislation.gov.uk/eudr/2001/82/article/13b (the official version)
Page: https://openlegislation.uk/eu-directive-2001-82/article-13b
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.