Article 3: Content of the Annex to the pharmacovigilance system master file

(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).