Paragraph 26 F1

The list mentioned in paragraph 25 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 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 under regulation 257D.

Annotations

Textual amendments

F1: Sch. 27 Pt. 3 inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 204(6) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 158(e)); 2020 c. 1, Sch. 5 para. 1(1)

Notes on Part 3

Textual amendments

F2: Words in Sch. 27 Pt. 3 heading 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(c)