Statutory Instruments
MEDICINES
Made
26th February 1974
Laid before Parliament
6th March 1974
Coming into Operation
7th March 1974
The Secretaries of State respectively concerned with health in England and in Wales, the Secretary of State concerned with health and with agriculture in Scotland, the Minister of Agriculture, Fisheries and Food, the Head of the Department of Health and Social Services for Northern Ireland and the Head of the Department of Agriculture for Northern Ireland, acting jointly, in exercise of powers conferred by section 13(2) of the Medicines Act 1968 and now vested in them(1) and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by the following order, hereby make the following order:—
1.—(1) This order may be cited as the Medicines (Exemption from Licences) (Emergency Importation) Order 1974 and shall come into operation on 7th March 1974.
(2) In this order, unless the context otherwise requires, “the Act” means
(3) Except in so far as the context otherwise requires, any reference in this order to any enactment (including any enactment of the Parliament of Northern Ireland) or order shall be construed as a reference to that enactment or order as amended or extended by any other enactment, Measure of the Northern Ireland Assembly or order.
(4) The rules for the construction of Acts of Parliament contained in the Interpretation Act 1889 shall apply for the purposes of the interpretation of this order as they apply for the purposes of the interpretation of an Act of Parliament.
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(2).
Keith Joseph
Secretary of State for Social Services
13th February 1974
Peter Thomas
Secretary of State for Wales
14th February 1974
Gordon Campbell
Secretary of State for Scotland
15th February 1974
In witness whereof the official seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 21st February 1974.
L.S.
Joseph Godber
Minister of Agriculture, Fisheries and Food
Patrick J. Devlin
Head of the Department of Health and Social Services for Northern Ireland
25th February 1974
Leslie J. Morrell
Head of the Department of Agriculture for Northern Ireland
26th February 1974
This Order exempts from the restriction imposed by section 7(3) of the Medicines Act 1968, under which the importation of medicinal products is prohibited except in accordance with a product licence, importation that becomes necessary by reason of the circumstances described in Article 2(2) of the Order. The exemption applies only to the importation of medicinal products that are already the subject of a product licence of right and where certain conditions as to undertakings, declarations and notifications are satisfied (Article 2(3)). The exemption does not apply to certain veterinary drugs (Article 2(4)).
In the case of the Secretaries of State concerned with health in England and in Wales by virtue of Article 2(2) of and Schedule 1 to, the Transfer of Functions (Wales) Order 1969 (S.I. 1969/388(1969 I, p.1070)), and in the case of the Heads of the Northern Ireland Departments by virtue of section 40 of, and Schedule 5 to, the Northern Ireland Constitution Act 1973 (c. 36).
(1971 II, p. 3790).