# The Human Medicines Regulations 2012, Paragraph 9A


Except in the case of an active substance that contains human cells or tissues, or that is part of a medicinal product which is (or is in a form which means a dose or part of it is) to be administered immediately after manufacture, a written confirmation that the manufacturer of the medicinal product has verified compliance of the manufacturer of the active substance with the principles and guidelines of good manufacturing practice by conducting audits, in accordance with regulation 37(5)(a) and containing—
(a) information about the date of the audit; and
(b) a declaration that the outcome of the audit confirms that the manufacturing complies with the principles and guidelines of good manufacturing practice.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/8/paragraph/9A (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-8/paragraph-9A
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.