# Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, Article 13c

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

After the marketing authorisation has been granted, the marketing authorisation holder may allow use to be made of the pharmaceutical, safety and residues, pre-clinical and clinical documentation contained in the file for the veterinary medicinal product with a view to examining a subsequent application for a veterinary medicinal product having the same qualitative and quantitative composition in active substances and the same pharmaceutical form.

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Source: https://www.legislation.gov.uk/eudr/2001/82/article/13c (the official version)
Page: https://openlegislation.uk/eu-directive-2001-82/article-13c
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.