# 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), Article 127: Proof of the product quality for veterinary medicinal products

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

1. The marketing authorisation holder shall have at its disposal the results of the control tests carried out on the veterinary medicinal product or on the constituents and intermediate products of the manufacturing process, in accordance with the methods laid down in the marketing authorisation.
2. If a competent authority concludes that a batch of a veterinary medicinal product is not in conformity with the control report of the manufacturer or the specifications provided for in the marketing authorisation, it shall take measures in relation to the marketing authorisation holder and the manufacturer, and shall inform accordingly the competent authorities of other Member States in which the veterinary medicinal product is authorised, and also the Agency in case the veterinary medicinal product is authorised under the centralised procedure.

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Source: https://www.legislation.gov.uk/eur/2019/6/article/127 (the official version)
Page: https://openlegislation.uk/eu-regulation-2019-6/article-127
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.