# The Human Medicines Regulations 2012, Paragraph 8


Where the licence holder has been informed by the licensing authority that the strength, quality or purity of a batch of a medicinal product to which the licence relates has been found not to conform with—
(a) the specification for the finished product; or
(b) the provisions of these Regulations applicable to the medicinal product,
the holder must, if so directed, withhold the batch from distribution, so far as reasonably practicable, for a period (not exceeding six weeks) specified by the licensing authority.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/4/paragraph/8 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-4/paragraph-8
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.