# The Human Medicines Regulations 2012, Paragraph 16: Record management and data retention


(1) The licensing authority must—
(a) record all pharmacovigilance information, and ensure that it is handled and stored so as to allow for accurate reporting, interpretation and verification of that information; and
(b) put in place a record management system for all documents used for pharmacovigilance activities that ensures—
(i) the retrievability of those documents, and
(ii) the traceability of the measures taken to investigate safety concerns, of the timelines for those investigations and of decisions on safety concerns, including their date and the decision-making process.
(2) The licensing authority must arrange for the essential documents describing their pharmacovigilance system to be kept for at least five years, such period beginning with the day after the system has been formally terminated.
(3) Pharmacovigilance data and documents relating to individual authorised medicinal products must be retained by the licensing authority for as long as the product is authorised and for at least 10 years, such period beginning with the day after the UKMA(GB) or the UKMA(UK)(Category 1), as the case may be, has expired.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/12A/paragraph/16 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-12A/paragraph-16
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.