# Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, Article 35

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

1. Any application by the marketing authorization holder to vary a marketing authorization which has been granted in accordance with the provisions of this Chapter shall be submitted to all the Member States which have previously authorized the medicinal product concerned.
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2. In case of arbitration submitted to the Commission, the procedure laid down in Articles 32, 33 and 34 shall apply by analogy to variations made to marketing authorizations.

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Source: https://www.legislation.gov.uk/eudr/2001/83/article/35 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/article-35
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.