Version Superseded: 01/01/2025
Point in time view as at 01/01/2022.
The Human Medicines Regulations 2012, Paragraph 8 is up to date with all changes known to be in force on or before 06 May 2025. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
8. The list mentioned in paragraph 7 must—U.K.
(a)take into account the special requirements of particular categories of users (including, in particular, children, pregnant or breastfeeding women, the elderly and persons with specific pathological conditions);
(b)mention, if appropriate, possible effects on the ability to drive vehicles or to operate machinery; and
(c)list any excipients—
(i)if knowledge of the excipients is important for the safe and effective use of the product, and
(ii)the excipients are included in the guidance published pursuant to [F1published under regulation 257D in the case of products for sale or supply in Great Britain, or in the case of products for sale or supply in Northern Ireland, any guidance published pursuant to Article 65 of the 2001 Directive or under regulation 257D that is applicable to such products.]
Textual Amendments
F1Words in Sch. 27 para. 8(c)(ii) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 204(2) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 158(a)); 2020 c. 1, Sch. 5 para. 1(1)
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