Paragraph 16
The licence holder must place the quality control system referred to in Article 11(1) of the Good Manufacturing Practice Directive under the authority of the person notified to the licensing authority in accordance with paragraph 2(2)(h) of Schedule 3.
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))