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The Human Medicines Regulations 2012

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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.

Yn ôl i’r brig

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