# The Human Medicines Regulations 2012, Paragraph 1: Structure of the pharmacovigilance system master file


(1) The information in the pharmacovigilance system master file must be accurate and reflect the pharmacovigilance system in place.
(2) The holder may, where appropriate, use separate pharmacovigilance systems for different categories of medicinal products and if it does so, each such system must be described in a separate pharmacovigilance system master file.
(3) All medicinal products for which the holder obtained a UKMA(GB) or a UKMA(UK)(Category 1) in accordance with these Regulations must be covered by a pharmacovigilance system master file.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/12A/paragraph/1 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-12A/paragraph-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.