The Human Medicines Regulations 2012

Provisional determination U.K.

159.—(1) This regulation applies if the licensing authority thinks that a product without a [F1 UK] marketing authorisation, traditional herbal registration, certificate of registration or [F2 , only in relation to a product for sale or supply in Northern Ireland, an Article 126a authorisation or an EU marketing authorisation,] is a medicinal product.

(2) The licensing authority may give a notice in writing (a “provisional determination notice”) to any person (the “recipient”)—

(a) who has sold or supplied the product, or has offered to sell or supply it; or

(b) whom the licensing authority thinks may sell or supply the product.

(3) The provisional determination notice must—

(a) advise the recipient that the licensing authority has made a provisional determination that the product is a medicinal product;

(b) give reasons for the provisional determination;

(c) advise the recipient of the recipient's rights to challenge the provisional determination in accordance with regulation 160 and

(d) specify a period of at least six weeks beginning immediately after the date on which the provisional determination notice is given to the recipient (in this Part “the determination date”) within which any written representations in accordance with regulation 160(2)(a) must be made to the licensing authority.

Textual Amendments

F1 Word in reg. 159(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 133(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in reg. 159(1) substituted (31.12.2020) by virtue of S.I. 2019/775, reg. 133(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 100)