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.