Paragraph 19
The licence holder must—
(a)
keep readily available for inspection by a person authorised by the licensing authority the batch documentation referred to in Article 9(1) of the Good Manufacturing Practice Directive; and
(b)
permit the person authorised to take copies or make extracts from such documentation.
Notes on Part 2
Textual amendments
- F1
Words in Sch. 4 Pt. 2 heading inserted (31.12.2020) by S.I. 2019/775, regs. 1, 20(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 14(c))