9. Where the holder of the authorisation has been informed by the licensing authority that any batch of any investigational medicinal product [or EAMS medicinal product] to which his authorisation 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, [or the 2012 Regulations] that are applicable to the investigational medicinal product [or EAMS medicinal product],
he shall, if so directed, withhold such batch from distribution for use in clinical trials [or as part of the Early Access to Medicines Scheme], so far as may be reasonably practicable, for such a period not exceeding six weeks as may be specified by the licensing authority.