The Human Medicines Regulations 2012

Explanatory Note

(This note is not part of the Regulations)

These Regulations consolidate the law of the United Kingdom concerning medicinal products for human use (“products”) in respect of the topics described below.

Parts 1 (general) and 2 (administration) consolidate, with only minor and drafting amendments, the administration provisions in Part 1 of the Medicines Act 1968 (“the 1968 Act”), including the definition of the licensing authority as the body responsible for regulating products. Part 1 also provides for interpretation, and for special provisions concerning the applicability of the Regulations to a number of activities by pharmacists and others. The latter provisions consolidate, with only minor and drafting amendments, provisions in Part 2 of the 1968 Act, except for the repeal of section 10(7) of the Act, which concerns wholesale dealing by pharmacists.

Part 3 (manufacturing and wholesale dealing) of the Regulations governs the manufacture and importation of, and wholesale dealing in, products. It consolidates, with only minor and drafting amendments, the provisions of Part 2 of the 1968 Act, and statutory instruments made under powers in that Part, on these topics. In doing so the Regulations continue to implement the obligations of the United Kingdom under Titles IV and VII of Directive 2001/83/EC of the European Parliament and of the Council on the Community Code relating to medicinal products for human use (“the 2001 Directive”) (OJ No L 311, 28.11.2001, p.67, as amended most recently by Directive 2010/84/EU of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community Code relating to medicinal products for human use (OJ No L 348, 31.12.2010, p.74 ) (“the 2010 Directive”)).

Part 4 (requirement for authorisation) of the Regulations establishes that products must not be sold, supplied, or offered for sale or supply in the United Kingdom unless authorised, either by the United Kingdom licensing authority under the Regulations, or by the European Commission under Regulation (EC) No 726/2004 of the European Parliament and of the Council laying down Community Procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (“Regulation (EC) No 726/2004”) (OJ No L 136, 30.4.2004, p.1, as amended most recently by Regulation (EU) No 1235/2010, OJ No L 348, 31.12.2010, p.1).

Parts 5 to 8 (marketing authorisations, certification of homoeopathic medicinal products, traditional herbal registrations and Article 126a authorisations) provide for the procedures for authorisation by the United Kingdom licensing authority of medicinal products in various categories. Part 5 (marketing authorisations) also provides for offences in the case of breach of the corresponding requirements in the procedures under Regulation (EC) No 726/2004, and for the breach of certain obligations under Regulation (EC) No 1901/2006 of the European Parliament and of the Council on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ No L 378, 27.12.2006, p.1, as amended by Regulation (EC) No 1902/2006 (OJ No L 378, 27.12.2006, p.20).

In respect of United Kingdom authorisation, Parts 4 to 8 of the Regulations consolidate, with only minor and drafting amendments, the following principal statutory instruments: the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (S.I. 1994/3144, as amended, most recently by S.I. 2010/1882) (“the marketing authorisations regulations”), the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 (S.I. 1994/105, as amended, most recently by S.I. 2006/2407) (“the homoeopathic regulations”), except in respect of fees provisions that are not being revoked, and the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 (S.I. 2005/2750, as amended, most recently by S.I. 2010/1621) (“the traditional herbal regulations”). In doing so, the Regulations continue to implement Titles III and VI of the 2001 Directive. At the same time the Regulations repeal the parallel national scheme for the licensing of the sale and supply of products, found in Part 2 of the 1968 Act, but now almost entirely superseded by EU provision in this field.

Part 9 (borderline products) of the Regulations consolidates, with only minor and drafting amendments, provision in the marketing authorisations regulations for the licensing authority to determine whether products that are supplied without authorisation are medicinal products and thus subject to the Regulations.

Part 10 (exceptions) consolidates, with only minor and drafting amendments, provisions in the marketing authorisations regulations, the homoeopathic regulations and the traditional herbal regulations concerning exemptions from the requirement for authorisation.

Part 11 (pharmacovigilance) consolidates provisions in the marketing authorisations regulations and the traditional herbal regulations concerning the monitoring of the safety of medicines in clinical use. This Part also implements the amendments to Title IX of the 2001 Directive made by the 2010 Directive. Part 11 also provides for offences in the case of breach of the corresponding requirements under Regulation (EC) No 726/2004.

Part 12 (dealings with medicinal products) governs the circumstances in which products may be sold, supplied and administered, and consolidates, with only minor and drafting amendments, the greater part of Part 3 of the 1968 Act, certain provisions of the latter which are outside the scope of the 2001 Directive being left unrepealed.

Parts 1, 3, 5, 10 and 12 contain provisions consolidating the effect of the Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010 (S.I. 2010/1882). In so doing, the Regulations continue to make provision necessary for the operation of Regulation (EC) No 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ No L324, 10.12.2007, p.21).

Part 13 (packaging and leaflets) Chapter 1 consolidates, with only minor and drafting amendments, provisions in the marketing authorisations regulations, the homoeopathic regulations and the traditional herbal registrations in respect of the information to be supplied with products, continuing to implement Title V of the 2001 Directive. Chapter 2 consolidates certain United Kingdom provisions on child safety in the presentation of products. Part 5 of the 1968 Act, which made parallel provision, is repealed, and the instruments made under it revoked, except in respect of certain powers outside the scope of the 2001 Directive.

Part 14 (advertising) consolidates, with only minor and drafting amendments, the Medicines (Advertising) Regulations 1994 (S.I. 1994/1932, as amended, most recently by S.I. 2006/2407) and the Medicines (Monitoring of Advertising) Regulations 1994 (S.I. 1994/1933, as amended, most recently by S.I. 2006/2407). In doing so, it continues to implement Titles VIII and VIIIa of the 2001 Directive. Part 6 of the 1968 Act, which made parallel provision, is repealed, and the instruments made under it revoked.

Part 15 (British Pharmacopoeia) consolidates, with only minor and drafting amendments, Part 7 of the 1968 Act.

Parts 16 (enforcement) and Part 17 (miscellaneous and general) consolidate, with only minor and drafting amendments, Part 8 (miscellaneous and supplementary provisions) of the 1968 Act as it concerns the topics in the Regulations. That Part remains in force, in amended form, in relation primarily to Part 4 (pharmacies) of the 1968 Act, which remains in force, and to certain other matters outside the scope of the 2001 Directive.

Impact assessments for these Regulations have been prepared and are available from the Medicines and Healthcare Products Regulatory Agency (“MHRA”), 151 Buckingham Palace Road, London SW1W 9SZ, and published with the explanatory memorandum alongside the Regulations on www.legislation.gov.uk. A transposition note for the 2010 Directive has been prepared, and is also available from MHRA.