# The Human Medicines Regulations 2012, Regulation 18: Wholesale dealing in medicinal products

Extent: E+W+S+N.I.

(1) A person may not except in accordance with a licence (a “wholesale dealer’s licence”)—
(a) distribute a medicinal product by way of wholesale dealing; ...
(b) possess a medicinal product for the purpose of such distribution; ...
(c) import a medicinal product into Great Britain from an approved country for import ; or
(d) supply a listed NIMAR product from Great Britain to Northern Ireland.
(2) Paragraph (1)—
(a) does not apply—
(i) to anything done in relation to a medicinal product by the holder of a manufacturer’s licence in respect of that product,
(ii) where the product concerned is an investigational medicinal product, or
(iii) if the product is a radiopharmaceutical in which the radionuclide is in the form of a sealed source; and
(b) is subject to regulation 19.
(2A) Paragraph (1)(c) does not apply to imports into Great Britain from an EEA State of medicinal products that have been released for sale, supply or distribution in an EEA State or the United Kingdom before IP completion day.
(2B) For the purposes of paragraph (2A) a medicinal product has been released for sale, supply or distribution where, after the stage of manufacturing has taken place, the product is the subject matter of a written or verbal agreement between two or more persons for the transfer of ownership, any other property right, or possession concerning the product, or where the product is the subject matter of an offer to a person to conclude such an agreement.
(3) Distribution of a medicinal product by way of wholesale dealing, or possession for the purpose of such distribution, is not to be taken to be in accordance with a wholesale dealer’s licence unless the distribution is carried on, or as the case may be the product held, at premises located in the UK and specified in the licence.
(4) In these Regulations a reference to distributing a product (including a listed NIMAR product) by way of wholesale dealing is a reference to—
(a) selling or supplying it; or
(b) procuring or holding it or exporting it for the purposes of sale or supply,
to a person who receives it for a purpose within paragraph (5) (but this is subject to paragraph (5A)).
(5) Those purposes are—
(a) selling or supplying the product; or
(b) administering it or causing it to be administered to one or more human beings,
in the course of a business carried on by that person.
(5A) In these Regulations, references to distributing a product by way of wholesale dealing do not include any sale or supply that is treated by virtue of regulation 222A(2)(a) as or as part of a retail sale.
(6) A wholesale dealer’s licence does not authorise the distribution of a medicinal product by way of wholesale dealing, or possession of a medicinal product for the purpose of such distribution, unless—
(a) in the case of a product for sale or supply in Great Britain, a UKMA(GB) or UKMA(UK), certificate of registration or traditional herbal registration is in force in respect of the product, ...
(b) in the case of a product for sale or supply in Northern Ireland, a UKMA(NI) or UKMA(UK) ..., Article 126a authorisation, certificate of registration or traditional herbal registration is in force in respect of the product, or
(c) in the case of a listed NIMAR product, a UKMA(GB) or UKMA(UK) is in force in respect of the product,
but this is subject to the exceptions in regulation 43(6).
(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/18 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-18
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.