# 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 108a

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

In order to facilitate the performance of pharmacovigilance activities within the Union, the Agency shall, in cooperation with competent authorities and other interested parties, draw up:
(a) guidance on good pharmacovigilance practices for both competent authorities and marketing authorisation holders;
(b) scientific guidance on post-authorisation efficacy studies.

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Source: https://www.legislation.gov.uk/eudr/2001/83/article/108a (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/article-108a
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.