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

a list of medicinal products covered by the pharmacovigilance system master file, including the name of each medicinal product, the international non-proprietary name (INN) of each active substance and the countries other than the United Kingdom in which the products covered are authorised to be marketed;

a list of written policies and procedures for the purpose of complying with Part 11 of these Regulations;

the list of any sub-contracts falling within paragraph 6(1);

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

a list of all scheduled and completed audits;

where applicable, a list of the performance indicators that support the quality system for pharmacovigilance specified in paragraph 2(e);

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

a logbook containing a record of any alteration of the content of the pharmacovigilance system master file made within the preceding 5 year period, except any alteration of the content that is specified in of paragraph 2(a)(ii) to (iv) or this paragraph.