Medicines Act 1968

General provisions and exemptions

6The licensing authority

(1)For the purposes of this Part of this Act the authority responsible for the grant, renewal, variation, suspension and revocation of licences and certificates shall be a body of Ministers consisting of all the Ministers specified in paragraphs (a) and (b) of section 1(1) of this Act.

(2)Any function conferred on the licensing authority by or under this Act may be performed by any one of those Ministers acting alone or by any two or more of them acting jointly.

(3)In accordance with the preceding provisions of this section, in this Act " the licensing authority " means any one or more of those Ministers, and, in the case of anything falling to be done by the licensing authority, means any one or more of those Ministers acting as mentioned in subsection (2) of this section.

7General provisions as to dealing with medicinal products

(1)The following provisions of this section shall have effect subject to—

(a)any exemption conferred by or under this Part of this Act;

(b)the provisions of this Part of this Act relating to clinical trials and medicinal tests on animals; and

(c)the provisions of section 48 of this Act.

(2)Except in accordance with a licence granted for the purposes of this section (in this Act referred to as a " product licence ") no person shall, in the course of a business carried on by him, and in circumstances to which this subsection applies.—

(a)sell, supply or export any medicinal product, or

(b)procure the sale, supply or exportation of any medicinal product, or

(c)procure the manufacture or assembly of any medicinal product for sale, supply or exportation.

(3)No person shall import any medicinal product except in accordance with a product licence.

(4)In relation to an imported medicinal product, subsection (2) of this section applies to circumstances in which the person selling, supplying or exporting the medicinal product in question, or procuring the sale, supply or exportation or the manufacture or assembly for sale, supply or exportation of that product, has himself imported the product or procured its importation.

(5)In relation to any medicinal product which has not been imported, subsection (2) of this section applies to any circumstances in which the person selling, supplying or exporting the medicinal product in question, or procuring the sale, supply or exportation or the manufacture or assembly for sale, supply or exportation of that product, is responsible for the composition of the product.

(6)For the purposes of subsection (5) of this section a person shall be taken to be responsible for the composition of a medicinal product if (but only if) in the course of a business carried on by him—

(a)he procures the manufacture of the product to his order by another person, where the order specifies, or incorporates by reference to some other document, particulars of the composition of the product ordered, whether those particulars amount to a complete specification or not, or

(b)he manufactures the product otherwise than in pursuance of an order which fulfils the conditions specified in the preceding paragraph.

8Provisions as to manufacture and wholesale dealing

(1)The following provisions of this section shall have effect without prejudice to the operation of section 7 of this Act, but subject to the exemptions and provisions referred to in paragraphs (a) to (c) of subsection (1) of that section.

(2)No person shall, in the course of a business carried on by him, manufacture or assemble any medicinal product except in accordance with a licence granted for the purposes of this subsection (in this Act referred to as a " manufacturer's licence ").

(3)No person shall, in the course of a business carried on by him, sell, or offer for sale, any medicinal product by way of wholesale dealing except in accordance with a licence granted for the purposes of this subsection (in this Act referred to as a " wholesale dealer's licence ").

9Exemptions for doctors, dentists, veterinary surgeons and veterinary practitioners

(1)The restrictions imposed by sections 7 and 8 of this Act do not apply to anything done by a doctor or dentist which—

(a)relates to a medicinal product specially prepared, or specially imported by him or to his order, for administration to a particular patient of his, and consists of manufacturing or assembling, or procuring the manufacture or assembly of, the product, or of selling or supplying, or procuring the sale or supply of, the product to that patient or to a person under whose care that patient is, or

(b)relates to a medicinal product specially prepared at the request of another doctor or dentist, or specially imported by him or to his order at the request of another doctor or dentist, for administration to a particular patient of that other doctor or dentist, and consists of manufacturing or assembling, or procuring the manufacture or assembly of, the product, or of selling or supplying, or procuring the sale or supply of, the product to that other doctor or dentist or to that patient or to a person under whose care that patient is.

(2)Subject to subsection (3) of this section, the restrictions imposed by sections 7 and 8 of this Act do not apply to anything done by a veterinary surgeon or veterinary practitioner which—

(a)relates to a medicinal product specially prepared for administration to a particular animal or herd which is under his care, and consists of manufacturing or assembling, or procuring the manufacture or assembly of, the product, or of selling or supplying, or procuring the sale or supply of, the product to a person having the possession or control of that animal or herd, or

(b)relates to a medicinal product specially prepared at the request of another veterinary surgeon or veterinary practitioner for administration to a particular animal or herd which is under the care of that other veterinary surgeon or veterinary practitioner, and consists of manufacturing or assembling, or procuring the manufacture or assembly of, the product, or of selling or supplying, or procuring the sale or supply of, the product to that other veterinary surgeon or veterinary practitioner or to a person having the possession or control of that animal or herd.

(3)The last preceding subsection shall not have effect so as to exempt from the restrictions imposed by sections 7 and 8 of this Act anything done by a veterinary surgeon or veterinary practitioner—

(a)in relation to a vaccine specially prepared for administration to poultry, or

(b)in relation to any other vaccine, unless the vaccine is specially prepared for administration to the animal from which it is derived, or

(c)in relation to plasma or a serum, unless the plasma or serum is specially prepared for administration to one or more animals in the herd from which it is derived.

10Exemptions for pharmacists

(1)Subject to the next following subsection, the restrictions imposed by sections 7 and 8 of this Act do not apply to anything which is done in a registered pharmacy, a hospital or a health centre and is done there by or under the supervision of a pharmacist and consists of—

(a)preparing or dispensing a medicinal product in accordance with a prescription given by a practitioner, or

(b)assembling a medicinal product;

and those restrictions do not apply to anything done by or under the supervision of a pharmacist which consists of procuring the preparation or dispensing of a medicinal product in accordance with a prescription given by a practitioner, or of procuring the assembly of a medicinal product.

(2)The exemption conferred by the preceding subsection does not apply to a vaccine specially prepared for administration to poultry, and does not apply to any other vaccine or any plasma or serum prepared or dispensed for administration to an animal or herd unless—

(a)in the case of a vaccine, it is specially prepared for administration to the animal from which it is derived, or

(b)in the case of plasma or a serum, it is specially prepared for administration to one or more animals in the herd from which it is derived,

and (in either case) it is so prepared in accordance with a prescription given by a veterinary surgeon or veterinary practitioner.

(3)Those restrictions do not apply to the preparation or dispensing in a registered pharmacy of a medicinal product by or under the supervision of a pharmacist in accordance with a specification furnished by the person to whom the product is or is to be sold or supplied, where—

(a)the product is prepared or dispensed for administration to that person or to a person under his care, or

(b)the product, not being a vaccine, plasma or serum, is prepared or dispensed for administration to an animal or herd which is in the possession or under the control of that person.

(4)Without prejudice to the preceding subsections, the restrictions imposed by sections 7 and 8 of this Act do not apply to anything which is done in a registered pharmacy by or under the supervision of a pharmacist and consists of—

(a)preparing or dispensing a medicinal product for administration to a person where the pharmacist is requested by or on behalf of that person to do so in accordance with the pharmacist's own judgment as to the treatment required, and that person is present in the pharmacy at the time of the request in pursuance of which that product is prepared or dispensed, or

(b)preparing a stock of medicinal products with a view to dispensing them as mentioned in subsection (1)(a) or subsection (3) of this section or in paragraph (a) of this subsection;

and those restrictions do not apply to anything which is done in a hospital or a health centre by or under the supervision of a pharmacist and consists of preparing a stock of medicinal products with a view to dispensing them as mentioned in subsection (1)(a) of this section.

11Exemption for nurses and midwives

(1)The restrictions imposed by section 8 of this Act do not apply to the assembly of any medicinal products by a person in the course of that person's profession as a registered nurse or as a certified midwife or, in relation to England and Wales, as an exempted midwife.

(2)In this section—

(a)in relation to England and Wales, " registered nurse " means a person for the time being registered as a nurse under the [1957 c. 15.] Nurses Act 1957, " certified midwife " means a woman whose name is for the time being on the roll of certified midwives kept under section 2 of the [1951 c. 53.] Mid-wives Act 1951, and "exempted midwife" means a woman named in an order for the time being having effect by virtue of section 6 of the [1953 c. 47.] Emergency Laws (Miscellaneous Provisions) Act 1953 (exemption of certain women from the [1951 c. 55.] Midwives Act 1951);

(b)in relation to Scotland, " registered nurse" means a person for the time being registered as a nurse under the Nurses (Scotland) Act 1951 and " certified midwife " means a woman whose name is for the time being on the roll of certified midwives kept under section 3 of the [1951 c. 54.] Midwives (Scotland) Act 1951; and

(c)in relation to Northern Ireland, " registered nurse" means a person for the time being registered as a nurse under the [1959 c. 19 (N.I.).] Nurses and Midwives Act (Northern Ireland) 1959, and " certified midwife " means a woman who is for the time being certified under Part III of that Act.

12Exemptions in respect of herbal remedies

(1)The restrictions imposed by sections 7 and 8 of this Act do not apply to the sale, supply, manufacture or assembly of any herbal remedy in the course of a business where—

(a)the remedy is manufactured or assembled on premises of which the person carrying on the business is the occupier and which he is able to close so as to exclude the public, and

(b)the person carrying on the business sells or supplies the remedy for administration to a particular person after being requested by or on behalf of that person and in that person's presence to use his own judgment as to the treatment required.

(2)Those restrictions also do not apply to the sale, supply, manufacture or assembly of any herbal remedy where the process to which the plant or plants are subjected in producing the remedy consists only of drying, crushing or comminuting, and the remedy is, or is to be, sold or supplied—

(a)under a designation which only specifies the plant or plants and the process and does not apply any other name to the remedy, and

(b)without any written recommendation (whether by means of a labelled container or package or a leaflet or in any other way) as to the use of the remedy.

13Exemptions for imports

(1)The restriction imposed by section 7(3) of this Act does not apply to the importation of a medicinal product by any person for administration to himself or to any person or persons who are members of his household, and does not apply to the importation of a medicinal product where it is specially imported by or to the order of a doctor or dentist for administration to a particular patient of his.

(2)Without prejudice to the preceding subsection, the restriction imposed by section 7(3) of this Act shall not apply to the importation of a medicinal product in such circumstances as may be specified in an order made by the Ministers for the purposes of this section.

(3)Any exemption conferred by an order under this section may be conferred either in relation to medicinal products generally or in relation to a class of medicinal products specified in the order, and (in either case) may be so conferred subject to such conditions or limitations as may be so specified.

14Exemption for re-exports

The restrictions imposed by sections 7 and 8 of this Act do not apply to the exportation, or the sale or offer for sale for the purposes of exportation, of any imported medicinal product if it is, or is to be, exported—

(a)in the form in which it was imported, and

(b)without being assembled in a way different from the way in which it was assembled on being imported.

15Provision for extending or modifying exemptions

(1)The appropriate Ministers may by order provide that sections 7 and 8 of this Act shall have effect subject to such exemptions (other than those for the time being having effect by virtue of sections 9 to 14 of this Act) as may be specified in the order.

(2)Any exemption conferred by an order under the preceding subsection may be conferred subject to such conditions or limitations as may be specified in the order.

(3)The appropriate Ministers may by order provide that any of the provisions of sections 9 to 14 of this Act specified in the order shall cease to have effect, or shall have effect subject to such exceptions or modifications as may be so specified.

(4)No order shall be made under subsection (3) of this section unless a draft of the order has been laid before Parliament and approved by a resolution of each House of Parliament.

16Transitional exemptions

(1)The restrictions imposed by sections 7 and 8 of this Act do not apply to anything done before such day as the Ministers may by order appoint for the purposes of this subsection (in this Act referred to as " the first appointed day"); and, except as otherwise provided by any order made under section 17 of this Act, the following provisions of this section shall have effect in relation to things done on or after that day.

(2)Section 7(2) of this Act shall not have effect in relation to a person in respect of his selling or supplying, or procuring the sale, supply, manufacture or assembly of, medicinal products of any description if, in the course of a business carried on by him, any medicinal products of that description were sold or supplied, or procured to be sold, supplied, manufactured or assembled, at any time before the first appointed day and medicinal products of that description were effectively on the market in the United Kingdom immediately before the first appointed day, and either—

(a)information with regard to the composition of medicinal products of that description, and as to their being available for sale or supply in the United Kingdom, had before that day been made known generally to doctors, or to any particular class of doctors, or to dentists or pharmacists, or to veterinary surgeons and veterinary practitioners, in the United Kingdom, or

(b)information that the products were available for sale or supply in the United Kingdom had before that day been made known generally to the public in the United Kingdom.

(3)Section 7(3) of this Act shall not have effect in relation to a person in respect of his importing medicinal products of any description in the course of a business carried on by him if, in the course of that business, medicinal products of that description were imported within the period of twenty-four months ending with the first appointed day.

(4)Section 8(2) of this Act shall not have effect in relation to a person in respect of his manufacturing or assembling medicinal products of any description in the course of a business carried on by him if in the course of that business—

(a)medicinal products of that description were manufactured or assembled within the period of twelve months ending with the first appointed day, or

(b)medicinal products of that description were manufactured or assembled before the beginning of that period and further supplies of such products could, if required, have been manufactured or assembled within that period:

Provided that this subsection shall not have effect in relation to any particular operations carried out in the course of a business on or after the first appointed day unless the manufacture or assembly of the products as mentioned in paragraph (a) or paragraph (b) of this subsection, as the case may be, included those operations.

(5)Section 8(3) of this Act shall not have effect in relation to a person in respect of his selling or offering for sale any medicinal products by way of wholesale dealing in the course of a business carried on by him if, in the course of that business, medicinal products were being sold or offered for sale by way of wholesale dealing within the period of twelve months ending with the first appointed day.

17Termination of transitional exemptions

For the purposes of subsections (2) to (5) of the last preceding section, the Ministers may by one or more orders under this section appoint one or more days, subsequent to the first appointed day, and may by any such order provide that such one or more of those subsections as may be specified in that order shall cease to have effect either—

(a)generally in relation to anything done on or after the day appointed by that order, or

(b)in relation to anything done on or after that day in so far as it consists of operations or activities, or relates to medicinal products of any such class, as may be so specified.