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The Human Medicines Regulations 2012
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Version Superseded: 17/10/2020
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Exemptions from requirement for wholesale dealer's licenceU.K.
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19.—(1) Regulation 18 does not apply to the sale or offer for sale of a medicinal product by way of wholesale dealing, or possession for the purpose of such sale or offer, where paragraph (2) applies and the person selling or offering the product for sale is—
(a)the holder of a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration, (an “authorisation”) which relates to the product, including a holder of an authorisation who manufactured or assembled the product; or
(b)a person who is not the holder of an authorisation in relation to the product but manufactured or assembled the product to the order of a person who is the holder of an authorisation relating to the product.
(2) This paragraph applies if—
(a)until the sale, the medicinal product has been kept on the premises of the person who manufactured or assembled the product (in this regulation referred to as “authorised premises”); and
(b)those premises are premises authorised for use for manufacture or assembly by that person's manufacturer's licence.
(3) For the purposes of this regulation, a medicinal product is regarded as having been kept on authorised premises at a time when—
(a)it was being moved from one set of authorised premises to another, or from one part of authorised premises to another part; or
(b)it was being moved from authorised premises by way of delivery to a purchaser.
(4) Regulation 18 does not apply to a person who in connection with the importation of a medicinal product—
(a)provides facilities solely for transporting the product; or
(b)acting as an import agent, handles the product where the product is imported solely to the order of another person who intends to sell the product or offer it for sale by way of wholesale dealing or to distribute it in any other way.
F1(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Reg. 19(5) omitted (20.8.2013) by virtue of The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 6
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