Article 3 Content of the Annex to the pharmacovigilance system master fileF1

The pharmacovigilance system master file shall have an Annex containing the following documents:

1. (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. (2)

   a list of written policies and procedures for the purpose of complying with Article 11(1);

3. (3)

   the list of subcontracts referred to in Article 6(2);

4. (4)

   a list of the tasks that have been delegated by the qualified person for pharmacovigilance;

5. (5)

   a list of all scheduled and completed audits;

6. (6)

   where applicable, a list of the performance indicators referred to in Article 9;

7. (7)

   where applicable, a list of other pharmacovigilance system master files held by the same marketing authorisation holder;

8. (8)

   a logbook containing the information referred to in Article 5(4).