# 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 10c

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

Following the granting of a marketing authorisation, the authorisation holder may allow use to be made of the pharmaceutical, pre-clinical and clinical documentation contained in the file on the medicinal product, with a view to examining subsequent applications relating to other medicinal products possessing the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form.

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Source: https://www.legislation.gov.uk/eudr/2001/83/article/10c (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/article-10c
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.