CHAPTER I

Pharmacovigilance system master file

Content of the Annex to the pharmacovigilance system master file
Article 3
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).
Regulation revoked in part (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(t) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)