The Human Medicines Regulations 2012

Effect of final determination U.K.

164.—(1) If the licensing authority makes a final determination that a product is a medicinal product, it may give a notice to any person—

(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.

(2) The notice must require the person—

(a) to cease to sell, supply or offer to sell or supply the product from the date specified in the notice until 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 granted in respect of the product; or

(b) not to sell, supply or offer to sell or supply the product unless a [F3 UK] marketing authorisation, traditional herbal registration, certificate of registration or [F4 , only in relation to a product for sale or supply in Northern Ireland, an Article 126a authorisation or an EU marketing authorisation,] is granted in respect of the product.

Textual Amendments

F1 Word in reg. 164(2)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 134(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in reg. 164(2)(a) substituted (31.12.2020) by S.I. 2019/775, reg. 134(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 101)

F3 Word in reg. 164(2)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 134(a); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in reg. 164(2)(b) substituted (31.12.2020) by virtue of S.I. 2019/775, reg. 134(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 101)