# 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 68: Implementation of variations requiring assessment

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

1. A marketing authorisation holder may implement a variation requiring assessment only after a competent authority or the Commission, as applicable, has amended the decision granting the marketing authorisation in accordance with that variation, has set a time limit for the implementation and has notified the marketing authorisation holder thereof in accordance with Article 67(3).
2. Where requested by a competent authority or the Commission, a marketing authorisation holder shall supply, without delay, any information related to the implementation of a variation.

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Source: https://www.legislation.gov.uk/eur/2019/6/article/68 (the official version)
Page: https://openlegislation.uk/eu-regulation-2019-6/article-68
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.