Paragraph 7 Classification of converted EU marketing authorisationsF1

For the purposes of regulation 62 (classification of UK marketing authorisation), it is a term of a converted EU marketing authorisation that the product to which the authorisation relates is to be available—

(a)

in a case where the product was classified in its EU marketing authorisation immediately before IP completion day as a prescription only medicine, the product is to be available only on prescription;

(b)

in a case where the product was not so classified and the licensing authority has determined that the product should be available on general sale, the product is to be available on general sale; or

(c)

in any other case, the product is to be available only from a pharmacy.

Annotations

Textual amendments

F1: Sch. 33A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 7 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 193); 2020 c. 1, Sch. 5 para. 1(1)