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 (c. 83)

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[F1 TITLE IX U.K. PHARMACOVIGILANCE

CHAPTER 5 U.K. Implementation, Delegation and Guidance

Article 108a U.K.

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.]

Textual Amendments

F1 Substituted by Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance).