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Paragraph 61 F1

A list of—

(a)

where the product is injectable or is a topical or eye preparation, all excipients; or

(b)

in any other case, those excipients known to have a recognised action or effect and included in the guidance published under regulation 257D that is applicable to such products.

Annotations

Textual amendments

F1

Sch. 24 Pts. 6, 7 inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 38