# 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 C: FIELD STUDIES

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

Unless justified, results from laboratory studies shall be supplemented with data from field studies, using batches according to the manufacturing process described in the marketing authorisation application. Both safety and efficacy may be investigated in the same field studies.

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Source: https://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/3/division/C (the official version)
Page: https://openlegislation.uk/eu-directive-2001-82/annex-I/title-II/part-3/division-C
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.