The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

Amendment of regulation 26 (general power to suspend, revoke or vary licences) U.K.

[F1 21.   For regulation 26(5)(a) substitute—

“(a) that the holder of the manufacturer’s licence has manufactured or assembled medicinal products to the order of a person who holds—

(i) in the case of a product for sale or supply in Great Britain, a UKMA(GB), a UKMA(UK), a COR(GB), a COR(UK), a THR(GB) or a THR(UK) (an “authorisation”), or

(ii) in the case of a product for sale or supply in Northern Ireland, a UKMA(NI), a UKMA(UK), a COR(NI), a COR(UK), a THR(NI) or a THR(UK), an EU marketing authorisation or an Article 126a authorisation (an “authorisation”),

and has habitually failed to comply with the provisions of that authorisation; or”.]

Textual Amendments

F1 Reg. 21 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 15

Commencement Information

I1 Reg. 21 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1