OpenLegislation

Paragraph 4

The holder of the authorisation may use a contract laboratory pursuant to Article 11(2) of Commission Directive 2003/94/EC F1in respect of Great Britain, or Article 10(2) of Commission Delegated Regulation 2017/1569 in respect of Northern Ireland, if operated by a person approved by the licensing authority.

Annotations

Textual amendments

F1

Words in Sch. 7 Pt. 2 para. 4 inserted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 42(3)(b)