# 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 10b

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

In the case of medicinal products containing active substances used in the composition of authorised medicinal products but not hitherto used in combination for therapeutic purposes, the results of new pre-clinical tests or new clinical trials relating to that combination shall be provided in accordance with Article 8(3)(i), but it shall not be necessary to provide scientific references relating to each individual active substance.

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