# The Human Medicines Regulations 2012, Paragraph 23


Where the application relates to active substances intended for use in an advanced therapy medicinal product, an outline of the arrangements for maintaining records to allow traceability containing sufficient detail to enable the linking of an active substance to the advanced therapy medicinal product it was used in the manufacture of and vice versa.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/7A/paragraph/23 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-7A/paragraph-23
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.