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The Human Medicines (Amendment) Regulations 2013

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Substitution of regulation 18

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5.  For regulation 18 (wholesale dealing in medicinal products) substitute—

“Wholesale dealing in medicinal products

18.—(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; or

(b)possess a medicinal product for the purpose of such distribution.

(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.

(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 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).

(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.

(6) A wholesale dealer’s licence does not authorise the distribution of a medicinal product by way of wholesale dealing, or possession for the purpose of such distribution, unless a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration is in force in respect of the product but this—

(a)does not apply in relation to distribution by a person to a person in a third country; and

(b)is subject to the exceptions in regulation 43(6).

(7) In paragraph (6), “marketing authorisation” means—

(a)a marketing authorisation issued by a competent authority of a member State in accordance with the 2001 Directive; or

(b)an EU marketing authorisation.”

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