Paragraph 16 F1
(1)
Subject to sub-paragraph (2), a mock-up, in accordance with Part 13 (packaging and leaflets) of—
(a)
the outer packaging of the medicinal product;
(b)
the immediate packaging of the medicinal product; and
(c)
the package leaflet for the medicinal product.
(2)
Sub-paragraph (1)(a) and (b) does not apply to an application for a marketing authorisation for a POC medicinal product which is (or is in a form which means a dose or part of it is) to be administered immediately after manufacture.
Annotations
Textual amendments
- F1
Sch. 8 para. 16 substituted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 37(3)