# Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance), 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/eur/2019/6/annex/II/title/II/part/3/division/C (the official version)
Page: https://openlegislation.uk/eu-regulation-2019-6/annex-II/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.