Regulation 159 Provisional determination

(1)

This regulation applies if the licensing authority thinks that a product without a F1UK 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 F3..., 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.

Annotations

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)
F3: Words in reg. 159(1) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 69