The Human Medicines Regulations 2012 No. 1916

SCHEDULES

SCHEDULE 8 U.K. Material to accompany an application for a UK marketing authorisation

PART 2 U.K. Summary of the product characteristics

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

[F1 23.   For medicinal products included on the list referred to— U.K.

(a) in the case of a medicinal product for sale or supply in Northern Ireland, in Article 23 of Regulation (EC) No 726/2004, the symbol and statement “▼ This medicinal product is subject to additional monitoring”, or

(b) in the case of a medicinal product for sale or supply in Great Britain, in regulation 202A, the symbol and statement “▼ This medicinal product is subject to additional monitoring”.]

Textual Amendments

F1 Sch. 8 para. 23 substituted (31.12.2020) by S.I. 2019/775, reg. 50(8) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 38(g))

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

25.  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.

[F2 25A.   In the case of an advanced therapy medicinal product for sale or supply in Great Britain which contains cells or tissues, a detailed description of those cells or tissues and of their specific origin, including the species of animal in cases of non-human origin.] U.K.

Textual Amendments

F2 Sch. 8 para. 25A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 50(9) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 38(h)); 2020 c. 1, Sch. 5 para. 1(1)

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

27.  Clinical particulars in relation to the medicinal product, covering— U.K.

(a) therapeutic indications;

(b) posology and method of administration for adults and, where necessary, for children;

therapeutic indications;

(c) contra-indications;

(d) special warnings and precautions for use and, in the case of immunological medicinal products any special precautions to be taken by persons handling such products and administering them to patients, together with any precautions to be taken by the patient;

(e) interaction with other medicinal products and other forms of interactions;

(f) use during pregnancy and lactation;

(g) effects on ability to drive and to use machines;

(h) other undesirable effects; and

(i) information on overdose (including symptoms, emergency procedures and antidotes).

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

(a) pharmacodynamic properties;

(b) pharmacokinetic properties; and

(c) pre-clinical safety data.

29.  Pharmaceutical particulars in relation to 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 container; and

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

30.  The holder of the UK marketing authorisation. U.K.

31.  The number of the UK marketing authorisation. U.K.

32.  The date of the first UK marketing authorisation or, where the UK marketing authorisation has been renewed, the date of the last renewal. U.K.

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

34.  For radiopharmaceuticals, full details of internal radiation dosimetry. U.K.

35.  For radiopharmaceuticals, additional detailed instructions for extemporaneous preparation and quality control of such preparation and, where appropriate, maximum storage time during which any intermediate preparation such as an eluate or the ready-to-use pharmaceutical will conform with its specifications. U.K.

[F3 36.   In the case of an advanced therapy medicinal product for sale or supply in Great Britain— U.K.

(a) references in this Part of this Schedule to administration of a product include references to the advanced therapy medicinal product's use, application or implantation; and

(b) descriptions, instructions and warnings must include explanatory drawings and pictures where necessary.]

Textual Amendments

F3 Sch. 8 para. 36 inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 50(10) (as amended by (S.I. 2020/1488, reg. 1, Sch. 2 para. 38(i)); 2020 c. 1, Sch. 5 para. 1(1)