# The Human Medicines Regulations 2012, Paragraph 3: Content of the Annex to the pharmacovigilance system master file


The pharmacovigilance system master file must have an Annex containing the following documents—
(a) 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;
(b) a list of written policies and procedures for the purpose of complying with Part 11 of these Regulations;
(c) the list of any sub-contracts falling within paragraph 6(1);
(d) a list of the tasks that have been delegated by the qualified person for pharmacovigilance;
(e) a list of all scheduled and completed audits;
(f) where applicable, a list of the performance indicators that support the quality system for pharmacovigilance specified in paragraph 2(e);
(g) where applicable, a list of other pharmacovigilance system master files held by the same holder; and
(h) 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.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/12A/paragraph/3 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-12A/paragraph-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.