# The Human Medicines Regulations 2012, Paragraph 15


(1) The qualified person is responsible for ensuring, in relation to a medicinal product, that documentary evidence is produced that each batch of the product satisfies the requirements of paragraph 12.
(2) The documentary evidence referred to in sub-paragraph (1) must be kept up to date and must be available for inspection by the licensing authority for a period of at least five years.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/7/paragraph/15 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-7/paragraph-15
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.