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).