Paragraph 20

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 of the medicinal product in question; or

(b)

those provisions of these Regulations that are applicable to the medicinal product,

the licence holder must, if so directed, withhold the batch from distribution, so far as reasonably practicable, for such a period (not exceeding six weeks) as may be specified by the licensing authority.

Notes on Part 2

Textual amendments

F1: Words in Sch. 4 Pt. 2 heading inserted (31.12.2020) by S.I. 2019/775, regs. 1, 20(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 14(c))