Paragraph 5
The holder of the authorisation shall—
(a)
keep readily available for inspection by a person authorised by the licensing authority the batch documentation referred to in Article 9(1) of Commission Directive 2003/94/EC F1in respect of Great Britain or Article 8 of Commission Delegated Regulation 2017/1569 in respect of Northern Ireland; and
(b)
permit the person authorised to take copies or make extracts from such documentation.
Annotations
Textual amendments
- F1
Words in Sch. 7 Pt. 3 para. 5(a) inserted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 42(4)(b)