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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 CELEX: 02001L0083-20250101 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. |