# 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 CHAPTER III:: PARTICULARS AND DOCUMENTS

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

The dossier on efficacy shall include all pre-clinical and clinical documentation and/or results of trials, whether favourable or unfavourable to the veterinary medicinal products, in order to enable an objective overall assessment of the risk/benefit balance of the product.

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Source: https://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/4/chapter/III (the official version)
Page: https://openlegislation.uk/eu-directive-2001-82/annex-I/title-I/part-4/chapter-III
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.