UK Legislation on Wholesale Distribution
The Human Medicines Regulations 2012 [SI 2012/1916]
Editor’s note
These extracts from the Regulations and Standard Provisions of the Human Medicines Regulations 2012 [SI 2012/1916] are presented for the reader’s convenience. Reproduction is with the permission of HMSO and the Queen’s Printer for Scotland. For any definitive information reference must be made to the original Regulations. The numbering and content within this section corresponds with the regulations set out in the published Statutory Instrument (SI 2012 No.1916).
1 (1) These Regulations may be cited as the Human Medicines Regulations 2012.
(2) These Regulations come into force on 14th August 2012.
8 (1) In these Regulations (unless the context otherwise requires):
“the 2001 Directive” means Directive 2001/83/EC of the European Parliament and of the Council on the Community Code relating to medicinal products for human use;
Article 126a authorisation” means an authorisation granted by the licensing authority under Part 8 of these Regulations;
“brokering” means all activities in relation to the sale or purchase of medicinal products, except for wholesale distribution, that do not include physical handling and that consist of negotiating independently and on behalf of another legal or natural person;
“Directive 2002/98/EC” means Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC;
“Directive 2004/23/EC” means Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells;
“electronic communication” means a communication transmitted (whether from one person to another, from one device to another or from a person to a device or vice versa):
(a) by means of an electronic communications network within the meaning of section 32(1) of the Communications Act 2003; or
(b) by other means but while in an electronic form;
“EU marketing authorisation” means a marketing authorisation granted or renewed by the European Commission under Regulation (EC) No 726/2004;
“European Economic Area” or “EEA” means the European Economic Area created by the EEA agreement;
“exempt advanced therapy medicinal product” has the meaning given in regulation 171;
“export” means export, or attempt to export, from the United Kingdom, whether by land, sea or air;
“falsified medicinal product” means any medicinal product with a false representation of:
(a) its identity, including its packaging and labelling, its name or its composition (other than any unintentional quality defect) as regards any of its ingredients including excipients and the strength of those ingredients;
(b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or
(c) its history, including the records and documents relating to the distribution channels used;
“Fees Regulations” means the Medicines (Products for Human Use) (Fees) Regulations 20131;
“herbal medicinal product” means a medicinal product whose only active ingredients are herbal substances or herbal preparations (or both);
“herbal preparation” means a preparation obtained by subjecting herbal substances to processes such as extraction, distillation, expression, fractionation, purification, concentration or fermentation, and includes a comminuted or powdered herbal substance, a tincture, an extract, an essential oil, an expressed juice or a processed exudate;
“herbal substance” means a plant or part of a plant, algae, fungi or lichen, or an unprocessed exudate of a plant, defined by the plant part used and the botanical name of the plant, either fresh or dried, but otherwise unprocessed;
“homoeopathic medicinal product” means a medicinal product prepared from homoeopathic stocks in accordance with a homoeopathic manufacturing procedure described by:
(a) the European Pharmacopoeia; or
(b) in the absence of such a description in the European Pharmacopoeia, in any pharmacopoeia used officially in an EEA State;
“import” means import, or attempt to import, into the UK, whether by land, sea or air;
“inspector” means a person authorised in writing by an enforcement authority for the purposes of Part 16 (enforcement) (and references to “the enforcement authority”, in relation to an inspector, are to the enforcement authority by whom the inspector is so authorised);
“the licensing authority” has the meaning given by regulation 6(2);
“manufacturer’s licence” has the meaning given by regulation 17(1);
“marketing authorisation” means:
(a) a UK marketing authorisation; or
(b) an EU marketing authorisation;
“medicinal product subject to general sale” has the meaning given in regulation 5(1) (classification of medicinal products);
“Regulation (EC) No 726/2004” means Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 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 1394/2007” means Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004;
“Regulation (EC) No 1234/2008” means Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products;
“the relevant EU provisions” means the provisions of legislation of the European Union relating to medicinal products for human use, except to the extent that any other enactment provides for any function in relation to any such provision to be exercised otherwise than by the licensing authority;
“relevant European State” means an EEA State or Switzerland;
“relevant medicinal product” has the meaning given by regulation 48;
“special medicinal product” means a product within the meaning of regulation 167 or any equivalent legislation in an EEA State other than the UK;
“third country” means a country or territory outside the EEA:
“traditional herbal medicinal product” means a herbal medicinal product to which regulation 125 applies;
“traditional herbal registration” means a traditional herbal registration granted by the licensing authority under these Regulations;
“UK marketing authorisation” means a marketing authorisation granted by the licensing authority under:
(a) Part 5 of these Regulations; or
(b) Chapter 4 of Title III to the 2001 Directive (mutual recognition and decentralised procedure);
“wholesale dealer’s licence” has the meaning given by regulation 18(1).
(2) In these Regulations, references to distribution of a product by way of wholesale dealing are to be construed in accordance with regulation 18(7) and (8).
(3) In these Regulations, references to selling by retail, or to retail sale, are references to selling a product to a person who buys it otherwise than for a purpose specified in regulation 18(8).
(4) In these Regulations, references to supplying anything in circumstances corresponding to retail sale are references to supplying it, otherwise than by way of sale, to a person who receives it otherwise than for a purpose specified in regulation 18(8);
Conditions for wholesale dealer’s licence
42 (1) Regulations 43 to 45 apply to the holder of a wholesale dealer’s licence (referred to in those regulations as “the licence holder”) and have effect as if they were provisions of the licence (but the provisions specified in paragraph (2) do not apply to the holder of a wholesale dealer’s licence insofar as the licence relates to exempt advanced therapy medicinal products).
(2) Those provisions are regulations 43(2) and (8) and 44.
(3) The requirements in Part 2 of Schedule 6 apply to the holder of a wholesale dealer’s licence insofar as the licence relates to exempt advanced therapy medicinal products, and have effect as if they were provisions of the licence.
43 (1) The licence holder must comply with the guidelines on good distribution practice published by the European Commission in accordance with Article 84 of the 2001 Directive.
(2) The licence holder must ensure, within the limits of the holder’s responsibility, the continued supply of medicinal products to pharmacies, and other persons who may lawfully sell medicinal products by retail or supply them in circumstances corresponding to retail sale, so that the needs of patients in the United Kingdom are met.
(3) The licence holder must provide and maintain such staff, premises, equipment and facilities for the handling, storage and distribution of medicinal products under the licence as are necessary:
(a) to maintain the quality of the products; and
(b) to ensure their proper distribution.
(4) The licence holder must inform the licensing authority of any proposed structural alteration to, or discontinuance of use of, premises to which the licence relates or which have otherwise been approved by the licensing authority.
(5) Subject to paragraph (6), the licence holder must not sell or supply a medicinal product, or offer it for sale or supply, unless:
(a) there is a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration (an “authorisation”) in force in relation to the product; and
(b) the sale or supply, or offer for sale or supply, is in accordance with the authorisation.
(6) The restriction in paragraph (5) does not apply to:
(a) the sale or supply, or offer for sale or supply, of a special medicinal product;
(b) the export to an EEA State, or supply for the purposes of such export, of a medicinal product which may be placed on the market in that State without a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration by virtue of legislation adopted by that State under Article 5(1) of the 2001 Directive; or
(c) the sale or supply, or offer for sale or supply, of an unauthorised medicinal product where the Secretary of State has temporarily authorised the distribution of the product under regulation 174.
(7) The licence holder must:
(a)
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