Regulation 164 Effect of final determination
If the licensing authority makes a final determination that a product is a medicinal product, it may give a notice to any person—
who has sold or supplied the product, or has offered to sell or supply it; or
whom the licensing authority thinks may sell or supply the product.
The notice must require the person—
to cease to sell, supply or offer to sell or supply the product from the date specified in the notice until 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 granted in respect of the product; or
not to sell, supply or offer to sell or supply the product unless a F4UK marketing authorisation, traditional herbal registration, certificate of registration or F5, only in relation to a product for sale or supply in Northern Ireland, an Article 126a authorisationF6..., is granted in respect of the product.
Annotations
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
Words in reg. 164(2)(a) 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), 70
- F4
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)
- F5
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)
- F6
Words in reg. 164(2)(b) 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), 70