Medicines (Advertising) Regulations 1994
| Jurisdiction | UK Non-devolved |
| Citation | SI 1994/1932 |
| Year | 1994 |
1994 No. 1932
MEDICINES
The Medicines (Advertising) Regulations 1994
Made 18th July 1994
Laid before Parliament 19th July 1994
Coming into force 9th August 1994
The Secretary of State, in exercise of the powers conferred on her by section 2(2) of the European Communities Act 19721, being designated for the purposes of section 2(2) of the Act in relation to medicinal products2, and the Secretaries of State respectively concerned with health in England, in Wales and in Scotland and the Department of Health and Social Services for Northern Ireland, acting jointly in exercise of powers conferred upon them by sections 61, 66(1)(i) and (j), 95(1), (2), (3), (4), (5) and (6) and 129(5) of the Medicines Act 19683, or, as the case may be, those conferred by the said provisions and now vested in them4, and those Ministers together with the Minister of Agriculture, Fisheries and Food, the Secretaries of State respectively concerned with agriculture in Scotland and in Wales and the Department of Agriculture for Northern Ireland, acting jointly in exercise of the powers conferred upon them by sections 85(1), 86(1) and 91(2) of the Medicines Act 19685, or, as the case may be, those conferred by the said provisions and now vested in them6, and in each case in exercise of all other powers so enabling them, after consulting in so far as is required such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations7, hereby make the following Regulations:
PART I
GENERAL
Citation and commencement
1. These Regulations may be cited as the Medicines (Advertising) Regulations 1994 and shall come into force on 9th August 1994.
Interpretation
2.—(1) In these Regulations—
“the Act” means the Medicines Act 1968;
“abbreviated advertisement” means an advertisement, other than a loose insert, which does not exceed in size an area of 420 square centimetres, in a publication sent or delivered wholly or mainly to persons qualified to prescribe or supply relevant medicinal products;
“common name” in relation to a relevant medicinal product means the international non-proprietary name, or, if one does not exist, the usual common name;
“essential information compatible with the summary of product characteristics” means essential information compatible—
(a) with the summary of product characteristics, if there is one, or
(b) if there is no summary of product characteristics, with the data sheet,
and “essential information” has the meaning it bears in Council Directive 92/28/EEC8;
“medicinal product for supply by prescription only” means a medicinal product of a description or falling within a class specified in any order made under section 58 of the Act9;
“medicinal product on a general sale list” means a medicinal product of a description or falling within a class specified in any order made under section 51(1) of the Act;
“name” in relation to a relevant medicinal product means the name given to the product which may be either an invented name or a common or scientific name, together with a trade mark or the name of the person responsible for marketing the product;
“pharmacy medicinal product” means a medicinal product which is neither a medicinal product for supply by prescription only nor a medicinal product on a general sale list;
“promotional aid” means a non-monetary gift made for a promotional purpose by a commercially interested party;
“reference material” includes entries which are in the form of, and limited to, a brief description of a medicinal product, its uses and any relevant contra-indications and warnings, appearing without charge in a publication consisting wholly or mainly of such entries where the publication is sent or delivered to persons qualified to prescribe or supply relevant medicinal products by a person who is not a commercially interested party;
“registered homoeopathic medicinal product” means a homoeopathic medicinal product10to which Council Directive 92/73/EEC11applies which is marketed in the United Kingdom under a certificate of registration12in accordance with the provisions of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 199413;
“relevant medicinal product” means—
(a) a medicinal product for human use to which Chapters II to V of the 1965 Directive14apply,
(b) a substance or article for human use—
(i) to which Chapters II to V of the 1965 Directive apply, and
(ii) specified in an order made under section 104 or 105 of the Act or in regulations made under section 2(2) of the European Communities Act 1972, which direct that Part VI or any section of that Part of the Act has effect in relation to such substance or article as that Part or section has effect in relation to medicinal products within the meaning of the Act, or
(c) a registered homoeopathic medicinal product,
but does not include a homoeopathic medicinal product in respect of which there is in force a product licence being a licence of right;
“summary of product characteristics” means the information required to accompany any application for a product licence by virtue of article 4a of the 1965 Directive which was inserted by article 1(2) of Council Directive 83/570/EEC15and amended by article 1(1) and (4) of Council Directive 89/341/EEC16;
and expressions used in these Regulations which are used in any provision of the Act have, subject to paragraph (2) and unless the context requires otherwise, the meaning which they bear in the Act.
(2) For the purposes of these Regulations, “advertisement” has the meaning assigned to it by section 92 of the Act, except that, in relation to a relevant medicinal product—
(a)
(a) provided that it makes no product claim, reference material, a factual, informative statement or announcement, a trade catalogue or a price list shall not be taken to be an advertisement, and
(b)
(b) an advertisement includes a representation,
and for the purposes of this paragraph, “representation” has the meaning assigned to it by section 92 of the Act, except that it does not include the making of a factual, informative statement or announcement which includes no product claim.
(3) In these Regulations, unless the context requires otherwise, a reference to a regulation, Part or Schedule is to that regulation in, Part of or Schedule to, these Regulations and any reference in a regulation or Schedule to a numbered paragraph is to the paragraph of that regulation or Schedule bearing that number.
PART II
Advertising—General
Prohibition of advertisements for unlicensed products
3.—(1) Subject to paragraph (2), no person shall issue an advertisement relating to a relevant medicinal product in respect of which no product licence is in force.
(2) This regulation shall not apply to any advertisement relating to a registered homoeopathic medicinal product.
Duties of licence holders
4. Any person who holds a product licence relating to a relevant medicinal product shall—
(a) establish a scientific service to compile and collate all information, whether received from medical sales representatives employed by him or from any other source, relating to that product;
(b) ensure that, in relation to any such product which medical sales representatives promote, those medical sales representatives are given adequate training and have sufficient scientific knowledge to enable them to provide information which is as precise and as complete as possible about that product;
(c) whenever required to do so by the licensing authority, furnish particulars of any advertisement or proposed advertisement for which he is responsible relating to that product, including particulars as to the contents and form of the advertisement, the method of dissemination and the date of first dissemination; and
(d) ensure that, in relation to an advertisement relating to that product, any decision taken by the licensing authority is immediately and fully complied with.
PART III
Advertising to the Public
Scope of Part III
5. This Part, with the exception of regulation 12 (prohibition of supply of medicinal products to the public), applies only to advertisements wholly or mainly directed at members of the general public, and accordingly references in this Part to advertisements are to advertisements to which this Part applies.
Prohibition of advertisements referring to specified diseases
6.—(1) Subject to paragraph (2)
and to regulation 11, no person shall issue an advertisement which is likely to lead to the use of a relevant medicinal product for the purpose of the treatment, prevention or diagnosis of any disease specified in, or any disease falling within a class of disease specified in, Schedule 1.
(2) Paragraph (1) shall not be taken to prohibit a person from issuing an advertisement which is likely to lead to the use of a relevant medicinal product for the purpose of the prevention of neural tube defects.
(3) No person shall issue an advertisement which is likely to lead to the use of a relevant medicinal product or any other medicinal product, substance or article for the purpose of inducing an abortion in women.
Prohibition of advertisements for medicinal products on prescription only
7. Subject to regulation 11, no person shall issue an advertisement which is likely to lead to the use of a relevant medicinal product which is a medicinal product for supply by prescription only and which is subject to any of the restrictions imposed by section 58(2) of the Act.
Prohibition of advertisements relating to certain medicinal products
8....
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