OpenLegislation

Paragraph 21 F1

Where an authorisation for the medicinal product to be placed on the market has been refused—

(a)

in the case of a medicinal product for sale or supply in Northern Ireland, by a member State or by a country other than an EEA State, or

(b)

in the case of a medicinal product for sale or supply in Great Britain, by a country other than the United Kingdom,

details of that decision and of the reasons for it.

Annotations

Textual amendments

F1

Sch. 8 para. 21 substituted (31.12.2020) by S.I. 2019/775, reg. 50(6) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 38(e))