Paragraph 8
The holder of the authorisation shall keep readily available for examination by a person authorised by the licensing authority the samples of each batch of bulk formulated products referred to in Article 11(4) of Commission Directive 2003/94/EC F1in respect of Great Britain or Article 11 of Commission Delegated Regulation 2017/1569 in respect of Northern Ireland.
Annotations
Textual amendments
- F1
Words in Sch. 7 Pt. 2 para. 8 inserted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 42(3)(d)