# The Human Medicines Regulations 2012, Paragraph 5: Form of the documents contained in the pharmacovigilance system master file


(1) The pharmacovigilance system master file documents must be complete and legible.
(2) Subject to sub-paragraph (1), in the pharmacovigilance system master file—
(a) where appropriate, information may be provided in the form of charts or flow diagrams;
(b) all documents must be indexed and archived so as to ensure their accurate and ready retrieval throughout the period for record-keeping; and
(c) the particulars and documents may be presented in modules in accordance with the system delineated in detail in the guidance on good pharmacovigilance practices which applies by virtue of regulation 205B.
(3) The pharmacovigilance system master file may be stored in electronic form provided that the media used for storage remain readable over time, and a clearly arranged printed copy can be made available for audits and inspections.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/12A/paragraph/5 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-12A/paragraph-5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.