There are outstanding changes not yet made by the legislation.gov.uk editorial team to The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005. Any changes that have already been made by the team appear in the content and are referenced with annotations.
5. Where the manufacturer's licence holder has been informed by the licensing authority that any batch of any medicinal product to which his licence relates has been found not to conform as regards strength, quality or purity with—U.K.
(a)the specification of the relevant product; or
(b)the provisions of these Regulations, the Act or any regulations under the Act that are applicable to the investigational medicinal product,
he shall, if so directed, withhold such batch from distribution, so far as may be reasonably practicable, for such a period not exceeding six weeks as may be specified by the licensing authority.
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