Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Order 1983
| Jurisdiction | UK Non-devolved |
| Citation | SI 1983/1212 |
1983 No. 1212
MEDICINES
The Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Order 19833rdAugust 1983
24thAugust 1983
14thSeptember 1983
The Secretary of State concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Wales and in Scotland, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly, in exercise of powers conferred by sections 58(1) and (4), 59 and 129(4) of the Medicines Act 1968(a) and now vested in them (b) 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 this order pursuant to section 129(6) of that Act, and after consulting and taking into account the advice of the Medicines Commission pursuant to sections 58(6) and 129(7) of that Act, hereby make the following order:—
Citation, commencement and interpretation
1.—(1) This order may be cited as the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Order 1983 and shall come into operation on 14th September 1983.
(2) In this order, unless the context otherwise requires—
(a) "the Act" means the Medicines Act 1968;
"aerosol" means a product which is dispersed from its container by a propellent gas or liquid;
"controlled drug" has the meaning assigned to it by section 2 of the Misuse of Drugs Act 1971(c);
(a) 1968 c. 67.
(b) 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), in the case of the Secretary of State concerned with agriculture in Wales by virtue of Article 2(3) of, and Schedule 1 to, the Transfer of Functions (Wales) (No. 1) Order 1978 (S.I. 1978/272) and in the case of the Northern Ireland Departments by virtue of section 40 of, and Schedule 5 to, the Northern Ireland Constitution Act 1973 (c. 36), and section 1(3) of, and paragraph 2(1)(b) of Schedule 1 to, the Northern Ireland Act 1974 (c. 28).
(c) 1971 c. 38.
"dosage unit" means—
(i) where a medicinal product is in the form of a tablet or capsule or is an article in some other similar pharmaceutical form, that tablet, capsule or other article, or
(ii) where a medicinal product is not in any such form, that quantity of the product which is used as the unit by reference to which the dose is measured;
"external use" means application to the skin, hair, teeth, mucosa of the mouth, throat, nose, ear, eye, vagina or anal canal when a local action only is intended and extensive systemic absorption is unlikely to occur; and references to medicinal products for external use shall be read accordingly except that such references shall not include throat sprays, throat pastilles, throat lozenges, throat tablets, nasal drops, nasal sprays, nasal inhalations or teething preparations;
"health prescription" means a prescription issued by a doctor or dentist under or by virtue of—
(i) in England and Wales, the National Health Service Act 1977(a),
(ii) in Scotland, the National Health Service (Scotland) Act 1978(b), and
(iii) in Northern Ireland, the Health and Personal Social Services (Northern Ireland) Order 1972(c);
"inhaler" does not include an aerosol;
"master" has the same meaning as in the Merchant Shipping Act 1894(d);
"maximum daily dose" or "MDD" means the maximum quantity of a substance contained in the amount of a medicinal product for internal use which it is recommended should be taken or administered in a period of 24 hours;
"maximum dose" or "MD" means the maximum quantity of a substance contained in the amount of a medicinal product for internal use which it is recommended should be taken or administered at any one time;
"maximum strength" means such of the following as may be specified—
(i) the maximum quantity of a substance by weight or volume contained in a dosage unit of a medicinal product, and
(ii) the maximum percentage of a substance contained in a medicinal product calculated in terms of weight in weight, weight in volume, volume in weight or volume in volume, as appropriate;
"medicinal product" has the same meaning as in the Act except that it does not include a medicinal product which is a veterinary drug as defined in section 132(1) of the Act;
"the Misuse of Drugs Regulations" means, in relation to England, Wales and Scotland, the Misuse of Drugs Regulations 1973(e) and, in relation to
(a) 1977 c. 49.
(b) 1978 c. 29.
(c) S.I. 1972/1265 (N.I. 14).
(d) 1894 c. 60.
(e) S.I. 1973/797; relevant amending instruments are S.I. 1975/499, 1623, 1977/1380 and 1979/326.
Northern Ireland, the Misuse of Drugs (Northern Ireland) Regulations 1974(a);
"occupational health scheme" means a scheme in which a person, in the course of a business carried on by him, provides facilities for his employees for the treatment or prevention of disease;
"operator", in relation to an aircraft, means the person for the time being having the management of the aircraft;
"parenteral administration" means administration by breach of the skin or mucous membrane;
"prescription only medicine" means a medicinal product of a description or falling within a class specified in Article 3 of this order;
"registered ophthalmic optician" means a person who is registered in either of the registers of ophthalmic opticians established and maintained under section 2(a) of the Opticians Act 1958(b);
"repeatable prescription" means a prescription which contains a direction that it may be dispensed more than once;
"sell" means sell by retail as defined in section 131 of the Act and "sale" has a corresponding meaning;
"soap" means any compound of a fatty acid with an alkali or amine;
"state registered chiropodist" means a person who is registered in the register established and maintained under section 2(1) of the Professions Supplementary to Medicine Act 1960(c) by the Chiropodists Board;
"supply" means supply in circumstances corresponding to retail sale as defined in section 131 of the Act;
"unit preparation" means a preparation, including a mother tincture, prepared by a process of solution, extraction or trituration with a view to being diluted tenfold or one hundredfold, either once or repeatedly, in an inert diluent, and then used either in this diluted form or, where applicable, by impregnating tablets, granules, powders or other inert substances; and
(b) a reference—
(i) to a numbered section is to the section of the Act which bears that number,
(ii) to a numbered Article or Schedule is to the Article of, or Schedule to, this order which bears that number,
(iii) in an Article or in a Part of a Schedule to a numbered paragraph is to the paragraph of that Article or that Part of that Schedule which bears that number, and
(iv) in a paragraph to a lettered sub-paragraph is to the sub-paragraph of that paragraph which bears that letter.
(3) In Schedule 1—
(a) entries specified in columns 2, 3 and 4 of Parts I and II relate to the substances listed in column 1 against which they appear and where, in relation to a particular substance listed in column 1, an entry in
(a) S.R. (N.I.) 1974 No. 272, amended by S.R. (N.I.) 1975 No. 140, 326 and 1977 No. 290.
(b) 1958 c. 32.
(c) 1960 c. 66.
column 2, 3 or 4 bears a number or letter it relates only to such entries in the other of those columns as bear the same number or letter;
(b) the entries in column 4 of Part I shall be read subject to the note at the end of that Part; and
(c) the following abbreviations are used:
"g" for gram,
"mcg" for microgram,
"mg" for milligram,
"ml" for millilitre.
Appropriate Practitioners
2. For the purposes of section 58 (medicinal products on prescription only), doctors, dentists, veterinary surgeons and veterinary practitioners shall be appropriate practitioners in relation to all the descriptions and classes of medicinal products specified for the purposes of that section in Article 3.
Medicinal products on prescription only
3.—(1) There are hereby specified descriptions and classes of medicinal products for the purposes of section 58, namely—
(a) subject to Article 4(1), medicinal products consisting of or containing a substance listed in column 1 of Part I of Schedule 1;
(b) subject to Article 4(2) and Part II of Schedule 1, medicinal products that are controlled drugs;
(c) medicinal products specified in Part III of Schedule 1;
(d) subject to Article 4(3), medicinal products that are for parenteral administration whether or not they fall within sub-paragraph (a) or (b);
(e) medicinal products—
(i) which are not of a description and do not fall within a class specified in any of sub-paragraphs (a), (b), (c) or (d),
(ii) which are of a description in respect of which the conditions specified in section 59(1) are fulfilled, and
(iii) in respect of which a product licence is granted after the date of coming into operation of this order containing a provision to the effect that the method of sale or supply of the medicinal product is to be only in accordance with a prescription given by an appropriate practitioner.
(2) For the purposes of section 59(2)(a) (duration of restrictions for certain new products) the duration shall be a period of five years.
Medicinal products that are not prescription only
4.—(1) Notwithstanding Article 3(1)(a), a medicinal product shall not be a prescription only medicine by reason that it consists of or contains a particular substance listed in column 1 of Part I of Schedule 1 where—
(a) in relation to that substance there is an entry in one or more of columns 2, 3 and 4;
(b) the maximum strength in the product of that substance does not exceed the maximum strength, if any, specified in column 2; and
(c) the medicinal product is sold or supplied—
(i) if a pharmaceutical form or a route of...
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