Medicines (Labelling and Advertising to the Public) Regulations 1978
| Jurisdiction | UK Non-devolved |
1978 No. 41
MEDICINES
The Medicines (Labelling and Advertising to the Public) Regulations 1978
Made 16th January 1978
Laid before Parliament 17th January 1978
Coming into Operation 1st February 1978
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 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 section 85(1), section 86(1), section 91(2), section 95(1), (2), (3), (5) and (6) and section 129(5) of the Medicines Act 1968 and now vested in them1and 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 regulations, hereby make the following regulations:—
Citation, commencement and interpretation
1.—(1) These regulations may be cited as the Medicines (Labelling and Advertising to the Public) Regulations 1978 and shall come into operation on 1st February 1978.
(2) In these regulations, unless the context otherwise requires—
“” means
“”
“”
“”
“” means:
(a) in relation to England and Wales, the Greater London Council, a county council, a London borough council, a district council or the Common Council of the City of London;
(b) in relation to Scotland, a regional, islands or district council;
(c) in relation to Northern Ireland, a district council;
“”
“”
“” means a contraceptive substance or article (not being a veterinary drug) which acts wholly or mainly by chemical spermicidal means, but does not include—
(a) a contraceptive substance or article which is administered orally,
(b) an intra-uterine contraceptive device, or
(c) a spermicidal lubricant which is or is to be applied to a condom, cap, or diaphragm;
“” means
and other expressions have the same meanings as in the Act.
(3) Except in so far as the context otherwise requires, any reference in these regulations to any provision of any enactment shall be construed as a reference to that provision as amended or extended by any enactment or instrument and as including a reference to any provision which may re-enact or replace it.
(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 these regulations as they apply for the purposes of the interpretation of an Act of Parliament.
Prohibition of advertisements for medicinal products and other substances and articles referring to specified diseases
2.—(1) Subject to the following provisions of these regulations, no advertisement shall be issued which is likely to lead to the use of any medicinal product or other substance or article—
(a)
(a) for the purpose of the treatment of human beings for any disease specified in Schedule 1 to these regulations, the diagnosis of any such disease, except under the instruction of a doctor or dentist, or
(b)
(b) for the purpose of procuring the miscarriage of women.
(2) The prohibition imposed by paragraph (1) of this regulation does not apply in relation to the issue of an advertisement which relates to a medicinal product or other substance or article which is sold or supplied as a food or dietary supplement for persons suffering from diabetes.
(3) For the purposes of this regulation the following shall be included among the acts taken to constitute the issue of an advertisement, that is to say—
(a)
(a) the sale or supply or offer or exposure for sale or supply, of a medicinal product in a labelled container or package;
(b)
(b) the supply, with a medicinal product of any description, of a leaflet relating solely to medicinal products of that description.
Prohibition of advertisements for medicinal products on prescription only
3. Subject to the following provisions of these regulations, no advertisement shall be issued likely to lead to the use of any medicinal product which is for use by being administered to human beings and is of a description or falling within a class specified—
(a) in any order made under section 58(1) of the Act (medicinal products on prescription only) which is subject to the restrictions imposed by section 58(2) of the Act, or
(b) in any order made under section 62(1) of the Act which prohibits the retail sale or the supply in circumstances corresponding to retail sale of that medicinal product except where such sale or supply—
(i) takes place on premises which are a registered pharmacy and is by or under the supervision of a pharmacist in accordance with a prescription given by a doctor or a dentist, or
(ii) is by a doctor or dentist to his patient or to a person responsible for the care of his patient.
Prohibition of advertisements relating to medicinal products for the purpose of treatment of specified diseases
4.—(1) Subject to the following provisions of these regulations, no advertisement shall be issued relating to any medicinal product which is for use by being administered to human beings, not being a medicinal product of a description or falling within a class specified in regulation 3 of these regulations, which is likely to lead to the use of such a medicinal product—
(a)
(a) for the purpose of the treatment of human beings for, or the prevention in human beings of—
(i) any disease of a description specified in column 1 of Part I of Schedule 2 to these regulations, except a purpose specified in column 2 of that Part of that Schedule, subject to the restrictions (if any) specified in column 3 of that Part of that Schedule, or
(ii) any disease of any system or part of the body specified in column 1 of Part II of that Schedule, except a purpose specified in column 2 of that Part of that Schedule, subject to the restrictions (if any) specified in column 3 of that Part of that Schedule, or
(iii) any adverse condition specified in column 2 of Part III of that Schedule opposite a system or part of the body specified in column 1 of that part of that Schedule, except a purpose specified in column 3 of that Part of that Schedule;
(b)
(b) for the purpose of the treatment of human beings for any physical injury specified in column 1 of Part IV of that Schedule except where the medicinal product is in a form and used for a purpose specified in column 2 of that Part of that Schedule;
(c)
(c) for any purpose specified in Part V of that Schedule.
(2) The restrictions imposed by paragraph (1) of this regulation shall not apply in relation to the issue of an advertisement in a newspaper or journal or to the transmission of any advertisement by the Independent Broadcasting Authority under the Independent Broadcasting Act 1973 where the holder of a product licence has, as soon as is reasonably possible, complied with or taken all necessary steps to ensure compliance with any direction in writing given by the licensing authority to the effect that an advertisement relating to medicinal products of the particular description to which such product licence relates ought not to be issued for any of the purposes to which paragraph (1) relates.
(3) For the purposes of this regulation the following shall be included among the acts taken to constitute the issue of an advertisement, that is to say—
(a)
(a) the sale or supply, or offer or exposure for sale or supply, of a medicinal product in a labelled container or package;
(b)
(b) the supply, with a medicinal product of any description, of a leaflet relating solely to medicinal products of that description.
Prohibition of representations
5.—(1) Subject to the following provisions of these regulations no representation shall be made by a commercially interested party which is likely to lead to the use of a medicinal product or other substance or article to which regulation 2 of these regulations applies for a purpose specified in regulation 2, or a medicinal product to which regulation 4 of these regulations applies for a purpose specified in regulation 4, if the representation—
(a)
(a) is made in connection with the sale or supply, or offer for sale or supply, of a medicinal product or other substance or article to which regulation 2 applies, or a medicinal product to which regulation 4 applies, or
(b)
(b) is made to any person for the purpose of inducing him to purchase a medicinal product or other substance or article to which regulation 2 applies or a medicinal product to which regulation 4 applies from a person selling by retail medicinal products or other substances or articles to which regulation 2 or regulation 4 applies, or
(c)
(c) in the case of medicinal products to which regulation 2 or regulation 4 applies, is made to the patient of a doctor or dentist for the purpose of inducing him to request the doctor or dentist to prescribe medicinal products of that description.
(2) The prohibition imposed by sub-paragraph (a) or sub-paragraph (b) of paragraph (1) above does not apply to any representation—
(a)
(a) which is made by a pharmacist in relation to the sale or supply of a medicinal product where—
(i) the pharmacist dispenses the medicinal product in accordance with a prescription given by a doctor or dentist; or
(ii) the pharmacist is requested by or on behalf of a person to sell or supply the medicinal product in accordance with the pharmacist's own judgment as to the treatment required; or
(b)
(b) which is made by a chiropodist registered by the Chiropodists Board under the...
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