# 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 7: Sterility and purity test

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

Appropriate tests to demonstrate the absence of contamination by extraneous agents or other substances shall be carried out according to the nature of the immunological veterinary medicinal product, the method and the conditions of manufacture. If fewer tests than required by the relevant European Pharmacopoeia are routinely employed for each batch, the tests carried out shall be critical to the compliance with the monograph. Proof must be supplied that the immunological veterinary medicinal product would meet the requirements, if fully tested according to the monograph.

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Source: https://www.legislation.gov.uk/eur/2019/6/annex/II/title/II/part/2/division/E/division/7 (the official version)
Page: https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/part-2/division-E/division-7
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.