Paragraph 17
The licence holder may use a contract laboratory pursuant to Article 11(2) of the Good Manufacturing Practice Directive if operated by a person approved by the licensing authority.
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))