Paragraph 8

The list mentioned in paragraph 7 must—

(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 F2....

Annotations

Textual amendments

F1: Words 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)
F2: Words in Sch. 27 para. 8(c)(ii) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 143(a)