The Medicines (Advertising) Regulations 1994

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.  Subject to regulation 11, no person shall issue an advertisement relating to any relevant medicinal product which—

(a) contains a substance which is listed in any of Schedules I, II or IV to the Narcotic Drugs Convention(1)(where the product is not a preparation listed in Schedule III to that Convention); or

(b) contains a substance which is listed in any of Schedules I to IV of the Psychotropic Substances Convention(2)(where the product is not a preparation which may be exempted from measures of control in accordance with paragraphs 2 and 3 of article 3 of that Convention).

Prohibition of certain material in advertisements

9.—(1) Subject to regulation 11, no person shall issue an advertisement relating to any relevant medicinal product which contains any material which—

(a) gives the impression that a medical consultation or surgical operation is unnecessary, in particular by offering a diagnosis or by suggesting treatment by post, FAX or telephone,

(b) suggests that the effects of taking the medicinal product are guaranteed, are unaccompanied by side effects or are better than, or equivalent to, those of another identifiable treatment or medicinal product,

(c) suggests that health can be enhanced by taking the medicinal product,

(d) suggests that health could be affected by not taking the medicinal product,

(e) is directed exclusively or principally at children,

(f) refers to a recommendation by scientists, health professionals or persons who are neither of the foregoing but who, because of their celebrity, could encourage the consumption of medicinal products,

(g) suggests that the medicinal product is a foodstuff, cosmetic or other consumer product,

(h) suggests that the safety or efficacy of the medicinal product is due to the fact that it is natural,

(i) might, by a description or detailed representation of a case history, lead to erroneous self-diagnosis,

(j) refers, in improper, alarming or misleading terms, to claims of recovery,

(k) uses, in improper, alarming or misleading terms, pictorial representations of changes in the human body caused by disease or injury, or of the action of a medicinal product on the human body or parts thereof, or

(l) mentions that the medicinal product has been granted a product licence.

(2) In this regulation, “FAX” means the making of a facsimile copy of a document by the transmission of electronic signals.

Form and content of advertisements

10.—(1) Subject to paragraph (2), no person shal issue an advertisement relating to a relevant medicinal product unless that advertisement—

(a) is set out in such a way that it is clear that the message is an advertisement and so that the product is clearly identified as a medicinal product, and

(b) subject to regulation 22(2), includes the following—

(i) the name of the medicinal product,

(ii) if it contains only one active ingredient, the common name of the medicinal product,

(iii) the information necessary for correct use of the medicinal product, and

(iv) an express and legible invitation to read carefully the instructions on the leaflet contained within the package or on the label, as the case may be.

(2) This regulation shall not apply to an advertisement relating to a relevant medicinal product which is on a promotional aid if—

(a) the advertisement consists solely of the name of the product (or, in the case of a registered homoeopathic medicinal product, the scientific name of the stock or stocks), and

(b) the advertisement is intended solely as a reminder.

Exception for approved vaccination campaigns

11.  The provisions of regulations 6(1), 7, 8 and 9(1)(d) shall not apply to any advertisement as part of a vaccination campaign relating to a relevant medicinal product which is a vaccine or serum, provided that such campaign has been approved by the Health Ministers.

Prohibition of supply of medicinal products to the public

12.  No person—

(a) being the holder of a product licence; or

(b) in the course of a business carried on by him and consisting (wholly or partly) of manufacturing medicinal products or of selling medicinal products by way of wholesale dealing,

shall sell or supply for a promotional purpose any unsolicited relevant medicinal product to any member of the general public.

(1)

The Narcotic Drugs Convention and the Psychotropic Substances Convention are defined in section 58A(5) of the Act. Section 58A was inserted into the Act by S.I. 1992/3271.

(2)

1990 c. 42.