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2.—(1) The restriction imposed by section 7(3) of the Act (product licences for importation) shall not apply to the importation of a medicinal product in the circumstances, and subject to the conditions, specified in the following paragraphs of this Article.
(2) The exemption conferred by paragraph (1) above shall apply where, as a result (whether directly or indirectly) of—
(a)the occurrence of events by reason of which a proclamation of emergency has been declared under section 1 of the Emergency Powers Act 1920, as amended by the Emergency Powers Act 1964, or under section 1 of the Emergency Powers Act (Northern Ireland) 1926, as amended by the Emergency Powers (Amendment) Act (Northern Ireland) 1964, or
(b)any direction, authority, instruction or notice given, order or appointment made or other thing done under regulations made under section 2 of the said Act of 1920, or under section 2 of the said Act of Northern Ireland of 1926, or
(c)any order made or direction given under section 2 of the Fuel and Electricity (Control) Act 1973,
the arrangements for the manufacture or assembly of medicinal products of a particular description in the United Kingdom have been impeded to such an extent as to make it necessary to import a medicinal product of the same description.
(3) The said exemption shall apply if (and only if)—
(a)the medicinal product to be imported is a product that is of the same description as that of a medicinal product in respect of which there is in force a product licence, being a licence of right, which is held by the person importing the product or by the person on whose behalf the product is to be imported;
(b)undertakings and a declaration such as are described in subsections (a), (b) and (c) of section 19(3) of the Act have been given by or on behalf of the manufacturer of the medicinal product to be imported, or, in the absence of any such undertakings or declaration, the licensing authority have approved that manufacturer for the purpose; and
(c)the licensing authority have been notified of the proposed importation.
(4) The said exemption shall not apply if the medicinal product to be imported is a veterinary drug which comes within the class of products specified in Part II of the Schedule to the Medicines (Importation of Medicinal Products for Re-exportation) Order 1971(1).
(1971 II, p. 3790).
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