# Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (Text with EEA relevance), Article 3: Content of the Annex to the pharmacovigilance system master file

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

The pharmacovigilance system master file shall have an Annex containing the following documents:
(1)a list of medicinal products covered by the pharmacovigilance system master file, including the name of the medicinal product, the international non-proprietary name (INN) of the active substance(s), and the Member State(s) in which the authorisation is valid;
(2)a list of written policies and procedures for the purpose of complying with Article 11(1);
(3)the list of subcontracts referred to in Article 6(2);
(4)a list of the tasks that have been delegated by the qualified person for pharmacovigilance;
(5)a list of all scheduled and completed audits;
(6)where applicable, a list of the performance indicators referred to in Article 9;
(7)where applicable, a list of other pharmacovigilance system master files held by the same marketing authorisation holder;
(8)a logbook containing the information referred to in Article 5(4).

---
Source: https://www.legislation.gov.uk/eur/2012/520/article/3 (the official version)
Page: https://openlegislation.uk/eu-regulation-2012-520/article-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.