The Human Medicines Regulations 2012 No. 1916

SCHEDULES

SCHEDULE 12 U.K. Material to accompany an application for a traditional herbal registration

PART 2 U.K. Summary of the product characteristics

The summary of the product characteristics must contain the following information in the following order—

21.  For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004 [F1 or regulation 202A, as the case may be], the [F2 symbol and] statement “[F3 ▼] This medicinal product is subject to additional monitoring”. U.K.

Textual Amendments

F1 Words in Sch. 12 para. 21 inserted (31.12.2020) by S.I. 2019/775, reg. 115(3)(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 86)

F2 Words in Sch. 12 para. 21 inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 115(3)(b); 2020 c. 1, Sch. 5 para. 1(1)

F3 Symbol in Sch. 12 para. 21 inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 115(3)(c); 2020 c. 1, Sch. 5 para. 1(1)

22.  The name of the medicinal product followed by its strength and pharmaceutical form. U.K.

23.  The qualitative and quantitative composition, using the usual common name or chemical description, of the medicinal product in terms of— U.K.

(a) the active substances; and

(b) those excipients of which knowledge is essential for proper administration of the medicinal product.

24.  The pharmaceutical form of the medicinal product. U.K.

25.  The pharmacological properties of the medicinal product, covering— U.K.

(a) pharmacodynamic properties;

(b) pharmacokinetic properties; and

(c) pre-clinical safety data.

26.  Pharmaceutical particulars of the medicinal product, covering— U.K.

(a) a list of excipients;

(b) major incompatibilities;

(c) shelf life after reconstitution of the medicinal product or when the immediate packaging is opened for the first time (as appropriate);

(d) special precautions for storage;

(e) nature and contents of the container; and

(f) special precautions for disposal of the used medicinal product or waste materials derived from the medicinal product (as appropriate).

27.  The holder of the traditional herbal registration. U.K.

28.  The number of the traditional herbal registration. U.K.

29.  The date of the first traditional herbal registration or, where the traditional herbal registration has been renewed, the date of the last renewal. U.K.

30.  The date of any revisions of the text of the summary of the product characteristics. U.K.