Medicines Act 1968 (c. 67)

Part VIII U.K. Miscellaneous and Supplementary Provisions

Modifications etc. (not altering text)

C1 Pt. VIII (ss. 104–136) extended by S.I.s 1982/425, art. 3, 1984/187 art. 2; and extended with modifications by S.I. 1985/403, art. 3(1)

132 General interpretation provisions. U.K.

(1) In this Act, except in so far as the context otherwise requires, the following expressions have the meanings hereby assigned to them respectively, that is to say:—

• “analysis” includes micro-biological assay but no other form of biological assay, and “analyse” has a corresponding meaning;

• “animal” includes any bird, fish or reptile;

• [F1 “animal feeding stuff” means any substance which is intended for use either by being fed to one or more animals or as an ingredient in the preparation of such a substance, not being in either case a medicinal product.]

• “animal test certificate” has the meaning assigned to it by section 32 of this Act;

• “the appropriate committee” has the meaning assigned to it by section 4(6) of this Act;

• “the appropriate Ministers” shall be construed in accordance with section 1(2) of this Act;

• “assemble”, in relation to a medicinal product, means enclosing the product (with or without other medicinal products of the same description) in a container which is labelled before the product is sold or supplied, or, where the product (with or without other medicinal products of the same description) is already enclosed in the container in which it is to be sold or supplied, labelling the container before the product is sold or supplied in it, and “assembly” has a corresponding meaning;

• “business” includes a professional practice and includes any activity carried on by a body of persons, whether corporate or unincorporate;

• “clinical trial” and “clinical trial certificate” have the meanings assigned to them by section 31 of this Act;

• “the Commission” means the Medicines Commission established under this Act;

• “composition”, in relation to a medicinal product, means the ingredients of which it consists and the proportions, and the degrees of strength, quality and purity, in which those ingredients are contained in it respectively;

• “container”, in relation to a medicinal product, means the bottle, jar, box, packet or other receptacle which contains or is to contain it, not being a capsule, cachet or other article in which the product is or is to be administered, and where any such receptacle is or is to be contained in another such receptacle, includes the former but does not include the latter receptacle;

• “contravention” includes failure to comply and “contravene” has a corresponding meaning;

• “dentist” means a person registered in the dentists register under the [F2 Dentists Act 1984 or entered in the list of visiting EEC practitioners under Schedule 4 to that Act;]

[F3 “the 1965 Directive" means Council Directive 65/65/EEC of 26th January 1965 on the aproximation of provisions laid down by law, regulation or administrative action relating to medicinal products (as amended by Council Directive 89/341/EEC and as it applies in accordance with Council Directives 75/319/EEC, 89/342/EEC, 89/343/EEC and 89/381/EEC);

“the 1981 Directive" means Council Directive 81/851/EEC of 28th September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products (as amended by Council Directive 90/676/EEC);]

• “disease” includes any injury, ailment or adverse condition, whether of body or mind;

• [F4 “doctor” means a registered medical practitioner person within the meaning of Schedule 1 to the Interpretation Act 1978]

• [F5 “drugs authority” has the meaning assigned to it by section 108(12) of this Act;]

• “enforcement authority” means any Minister or body on whom a duty or power to enforce any provisions of this Act or of any regulations or order made thereunder is imposed or conferred by or under sections 108 to 110 of this Act;

• “export” means export from the United Kingdom, whether by land, sea or air, and “import” has a corresponding meaning;

• “the first appointed day” has the meaning assigned to it by section 16(1) of this Act;

• [F6 “food and drugs authority” has the meaning assigned to it for the purposes of the M1 Food and Drugs Act 1955 by [F7 section 198 of the M2 Local Government Act 1972];]

• “the Gazette” means the London, Edinburgh and Belfast Gazettes;

• “health centre” means a health centre maintained under [F8 section 2 or 3 of the M3 National Health Service Act 1977][F9 section 36 of the M4 National Health Service (Scotland) Act 1978] or [F10 Article 5 of the M5 Health and Personal Social Services (Northern Ireland) Order 1972];

• “herbal remedy” means a medicinal product consisting of a substance produced by subjecting a plant or plants to drying, crushing or any other process, or of a mixture whose sole ingredients are two or more substances so produced, or of a mixture whose sole ingredients are one or more substances so produced and water or some other inert substance;

• “herd” includes a flock;

• “hospital” includes a clinic, nursing home or similar institution;

• “hover vehicle” means a vehicle designed to be supported on a cushion of air;

• “ingredient”, in relation to the manufacture or preparation of a substance, includes anything which is the sole active ingredient of that substance as manufactured or prepared;

• “labelling”, in relation to a container or package of medicinal products, means affixing to or otherwise displaying on it a notice describing or otherwise relating to the contents, and “label” has a corresponding meaning;

• “leaflet” includes any written information;

• “the licensing authority” has the meaning assigned to it by section 6 of this Act;

• “licence of right” has the meaning assigned to it by section 25(4) of this Act;

• “manufacture”, in relation to a medicinal product, includes any process carried out in the course of making the product, but does not include dissolving or dispersing the product in, or diluting or mixing it with, some other substance used as a vehicle for the purpose of administering it and does not include the incorporation of the product in any animal feeding stuff;

• “medicinal test on animals” has the meaning assigned to it by section 32 of this Act;

• “offence under this Act” includes an offence under any regulations or order made under this Act;

• “package”, in relation to any medicinal products, means any box, packet or other article in which one or more containers of the products are or are to be enclosed, and, where any such box, packet or other article is or is to be itself enclosed in one or more other boxes, packets or other articles, includes each of the boxes, packets or articles in question;

• “Pharmaceutical Society” in relation to Great Britain means the Pharmaceutical Society of Great Britain, and in relation to Northern Ireland means the Pharmaceutical Society of Northern Ireland;

• “pharmacist” in relation to Great Britain means a person registered in the register of pharmaceutical chemists established in pursuance of the M6 Pharmacy Act 1852 and maintained in pursuance of section 2(1) of the M7 Pharmacy Act 1954, and in relation to Northern Ireland (subject to any order made under paragraph 1 of Schedule 4 to this Act) means a person registered in the register of pharmaceutical chemists for Northern Ireland made out and maintained under [F11 Articles 6 and 9 of the M8 Pharmacy (Northern Ireland) Order 1976];

• “plant” includes any part of a plant;

• “poultry” means domestic fowls, turkeys, geese, ducks, guinea-fowls, pigeons, pheasants and patridges;

• “practitioner" (except where that word occurs as part of the expression “veterinary practitioner") means a doctor, dentist, veterinary surgeon or veterinary practitioner;

• “prescribed” means prescribed by regulations under this Act;

• “product licence”, “manufacturer’s licence” and “wholesale dealer’s licence” have the meanings assigned to them by sections 7 and 8 of this Act;

• “registered pharmacy” has the meaning assigned to it by section 74 of this Act;

• “retail pharmacy business” means a business (not being a professional practice carried on by a practitioner) which consists of or includes the retail sale of medicinal products other than medicinal products on a general sale list (whether medicinal products on such a list are sold in the course of that business or not);

• “substance” means any natural or artificial substance, whether in solid or liquid form or in the form of a gas or vapour;

• “the time allowed", in Part II of, and Schedule 2 to, this Act has the meaning assigned to it by section 21(8) of this Act;

• “treatment”, in relation to disease, includes anything done or provided for alleviating the effects of the disease, whether it is done or provided by way of cure or not;

• “veterinary drug” means a medicinal product which is manufactured, sold, supplied, imported or exported for the purpose of being administered to animals, but not for the purpose of being administered to human beings;

• “veterinary practitioner” means a person registered in the supplementary veterinary register kept under section 8 of the M9 Veterinary Surgeons Act 1966;

• “veterinary surgeon” means a person registered in the register of veterinary surgeons kept under section 2 of the M10 Veterinary Surgeons Act 1966;

• “writing” includes any form of notation, whether by hand or by printing, typewriting or any similar process, and “written” has a corresponding meaning.

(2) For the purposes of this Act considerations of safety, in relation to any substance or article, shall be taken to include consideration of the extent (if any) to which the substance or article—

(a) if used without proper safeguards, is capable of causing danger to the health of the community, or of causing danger to the health of animals generally or of one or more species of animals, or

(b) if administered to an animal, may be harmful to the animal or may induce disease in other animals or may leave a residue in the carcase or produce of the animal which may be harmful to human beings, or

(c) may interfere with the treatment, prevention or diagnosis of disease, or

(d) may be harmful to the person administering it or (in the case of an instrument, apparatus or appliance) the person operating it,

and any reference in this Act to safety or to the interests of safety shall be construed accordingly.

(3) In this Act any reference to doing anything in accordance with a licence under Part II of this Act shall be construed as a reference to doing it in pursuance of such a licence and in compliance with any conditions and any limitations (whether as to area or otherwise) to which the licence is subject, and so as not to fall within any exceptions to which it is subject, and any reference to doing anything in accordance with a clinical trial certificate or an animal test certificate shall be construed in a corresponding way.

(4) Any reference in this Act to the holder of a licence or certificate shall be construed as a reference to the holder of a licence or certificate which is for the time being in force.

(5) For the purposes of this Act medicinal products of any description shall be taken to be effectively on the market in the United Kingdom at a particular time if (but only if) during the whole of the period of one month ending with that time adequate stocks of medicinal products of that description were available, or could within a reasonable time be made available, for sale or supply to such persons in the United Kingdom as were likely to require them.

(6) Except in so far as the context otherwise requires, any reference in this Act to an enactment shall be construed as a reference to that enactment as amended or extended by or under any other enactment, including this Act.

Textual Amendments

F1 Definition inserted by Animal Health and Welfare Act 1984 (c. 40, SIF 2:8), s. 13(3)

F2 Words substituted by virtue of Dentists Act 1984 (c. 24, SIF 83:1), s. 54(1), Sch. 5 para. 2

F3 Definitions in s. 132(1) added (1.1.1993) by S.I. 1992/3271, reg.3

F4 Definition substituted by Medical Act 1983 (c. 54, SIF 83:1), Sch. 5 para. 5

F5 Words inserted (E.W.S.) by Food Safety Act 1990 (c. 16, SIF 53:1, 2), ss. 54, 59(1), Sch. 3 para. 11

F6 Definition repealed (E.W.S.) by Food Safety Act 1990 (c. 16, SIF 53:1, 2), ss. 54, 59(1)(4), Sch. 3 para. 11, Sch. 5

F7 Words substituted by Local Government Act 1972 (c. 70), s. 198(2)

F8 Words substituted by National Health Service Act 1977 (c. 49), Sch. 15 para. 50

F9 Words substituted by National Health Service (Scotland) Act 1978 (c. 29), Sch. 16 para. 31

F10 Words substituted by National Health Service Reorganisation Act 1973 (c. 32), Sch. 4 para. 128(3)

F11 Words substituted by S.I. 1976/1213 (N.I. 22), Sch. 5 para. 7

Modifications etc. (not altering text)

C2 Pt. VIII (ss. 104–136) extended by S.I.s 1982/425, art. 3, 1984/187 art. 2; and extended with modifications by S.I. 1985/403, art. 3(1)

C3 S. 132 extended (3.4.1992) by S.I. 1992/605, regs. 2(4), 3

Marginal Citations

M1 1955 c. 16 (4 & 5 Eliz. 2).

M2 1972 c. 70.

M3 1977 c. 49.

M4 1978 c. 29.

M5 S.I. 1972 No. 1265.

M6 1852 c. 56.

M7 1954 c. 61.

M8 S.I. 1976/1213 (N.I. 22)

M9 1966 c. 36.

M10 1966 c. 36.