- Latest available (Revised)
- Point in Time (09/02/2019)
- Original (As made)
Version Superseded: 31/12/2020
Point in time view as at 09/02/2019.
The Human Medicines Regulations 2012, SCHEDULE 24 is up to date with all changes known to be in force on or before 26 August 2024. 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.
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Regulation 257
1. The name of the medicinal product.U.K.
2. The strength and pharmaceutical form of the product.U.K.
3. Where appropriate, whether the product is intended for babies, children or adults.U.K.
4. Where the product contains up to three active substances, the common name of each active substance.U.K.
5. A statement of the active substances in the product, expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names.U.K.
6. The pharmaceutical form and the contents by weight, by volume or by number of doses of the product.U.K.
7. A list of—U.K.
(a)where the product is injectable or is a topical or eye preparation, all excipients; or
(b)in any other case, those excipients known to have a recognized action or effect and included in the guidance published pursuant to Article 65 of the 2001 Directive.
8. The method of administration of the product and if necessary the route of administration.U.K.
9. Where appropriate, space for the prescribed dose to be indicated.U.K.
10. A warning that the product must be stored out of the reach and sight of children.U.K.
11. Any special warning applicable to the product.U.K.
12. The product's expiry date (month and year), in clear terms.U.K.
13. Any special storage precautions relating to the product.U.K.
14. Any special precautions relating to the disposal of an unused product or part of a product, or waste derived from the product, and reference to any appropriate collection system in place.U.K.
15. The name and address of the holder of the marketing authorisation, Article 126a authorisation or traditional herbal registration relating to the product and, where applicable, the name of the holder's representative.U.K.
16. The number of the marketing authorisation, Article 126a authorisation or traditional herbal registration for placing the medicinal product on the market.U.K.
17. The manufacturer's batch number.U.K.
18. In the case of a product that is not a prescription only medicine, instructions for use.U.K.
[F118A. In the case of a medicinal product, other than a radiopharmaceutical, that is required by Article 54a of the 2001 Directive to bear safety features—U.K.
(a)a unique identifier which complies with the technical specifications set out in Chapter II of Commission Regulation 2016/161; and
(b)an anti-tampering device allowing verification of whether the packaging of the medicinal product has been tampered with.]
Textual Amendments
F1Sch. 24 para. 18A inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 19 and Sch. 24 para. 18A inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 19
19. The name of the medicinal product.U.K.
20. The strength and pharmaceutical form of the product.U.K.
21. Where appropriate, whether the product is intended for babies, children or adults.U.K.
22. Where the product contains up to three active substances, the common name of each active substance.U.K.
23. The name of the holder of the marketing authorisation, Article 126a authorisation or traditional herbal registration relating to the product.U.K.
24. The product's expiry date (month and year), in clear terms.U.K.
25. The manufacturer's batch number.U.K.
26. The name of the medicinal product.U.K.
27. The strength and pharmaceutical form of the product.U.K.
28. Where appropriate, whether the product is intended for babies, children or adults.U.K.
29. Where the product contains up to three active substances, the common name of each active substance.U.K.
30. The method of administration of the product and if necessary the route of administration.U.K.
31. The product's expiry date (month and year), in clear terms.U.K.
32. The manufacturer's batch number.U.K.
33. The contents of the packaging by weight, by volume or by unit.U.K.
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