# The Human Medicines Regulations 2012, Paragraph 16


The licence holder must place the quality control system referred to in Article 11(1) of the Good Manufacturing Practice Directive under the authority of the person notified to the licensing authority in accordance with paragraph 2(2)(h) of Schedule 3.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/4/paragraph/16 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-4/paragraph-16
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.