The Medicines (Advertising) Regulations 1994

Regulation 6

SCHEDULE 1 Diseases in Respect of which Advertisements to the Public are Prohibited

• Bone diseases

• Cardiovascular diseases

• Chronic insomnia

• Diabetes and other metabolic diseases

• Diseases of the liver, biliary system and pancreas

• Endocrine diseases

• Genetic disorders

• Malignant diseases

• Psychiatric diseases

• Serious disorders of the eye and ear

• Serious gastrointestinal diseases

• Serious infectious diseases including HIV-related diseases and tuberculosis

• Serious neurological and muscular diseases

• Serious renal diseases

• Serious respiratory diseases

• Serious skin disorders

• Sexually transmitted diseases.

Regulations 14 and 15

SCHEDULE 2 Particulars to be Contained in Advertisements to Health Professionals

1.  The licence number of the medicinal product.

2.  The name and address of the holder of the product licence which relates to the medicinal product or the business name and address of the part of his business that is responsible for its sale or supply.

3.  The supply classification of the medicinal product, specifying whether the product is a medicinal product for supply by prescription only, a medicinal product on a general sale list, or a pharmacy medicinal product.

4.  The name of the product, and a list of the active ingredients using the common name placed immediately adjacent to the most prominent display of the name of the product.

5.  One or more of the indications for the product consistent with the terms of the licence.

6.  A succinct statement (where relevant) of the entries in the summary of product characteristics or, if there is no summary of product characteristics, the data sheet, relating to side-effects, precautions and relevant contra-indications.

7.  A succinct statement of the entries in the summary of product characteristics or, if there is no summary of product characteristics, the data sheet, relating to dosage and method of use relevant to the indications shwn. The method of administration should also be shown where this is not obvious.

8.  A warning issued by the licensing authority under Part II of the Act which is required to be included in advertisements.

9.  The cost (excluding value added tax) of either a specified package of the medicinal product to which the advertisement relates, or a specified quantity or recommended daily dose, calculated by reference to any specified package of the product, except that such cost may be omitted in the case of an advertisement inserted in a publication which is printed in the United Kingdom but with a circulation outside the United Kingdom of more than 15 per cent. of its total circulation.

10.  The particulars contained in paragraphs 6, 7 and 8 shall be printed in a clear and legible manner and be placed in such a position in the advertisement that their relationship to the claims and indications for the product can readily be appreciated by the reader.

Regulation 16

SCHEDULE 3 Particulars to be Contained in Abbreviated Advertisements

1.  The name and address of the holder of the product licence which relates to the medicinal product, or the business name and address of the part of his business that is responsible for its sale or supply.

2.  The supply classification of the medicinal product, specifying whether the product is a medicinal product for supply by prescription only, a medicinal product on a general sale list, or a pharmacy medicinal product.

3.  The name of the product, and a list of the active ingredients using the common name placed immediately adjacent to the most prominent display of the name of the product.

4.  A form of words which clearly indicates that further information is available on request to the licence holder or in the summary of product characteristics, or, if there is no summary of product characteristics, the data sheet, relating to the product.

Regulation 19

SCHEDULE 4 Conditions for the Supply of Free Samples

1.  Samples shall be supplied on an exceptional basis only.

2.  A limited number only of samples of each product may be suppied in any one year and to any one recipient.

3.  Samples shall be supplied only in response to a written request, signed and dated, from the recipient.

4.  Suppliers of samples shall maintain an adequate system of control and accountability.

5.  Every sample shall be no larger than the smallest presentation available for sale in the United Kingdom.

6.  Every sample shall be marked “free medical sample—not for resale” or shall bear a similar description.

7.  Every sample shall be accompanied by a copy of the summary of product characteristics (or, if there is no summary of product characteristics, a copy of the data sheet) for each such product.

Regulation 22

SCHEDULE 5 Particulars which may be Contained in Advertisements for Registered Homoeopathic Medicinal Products

1.  The scientific name of the stock or stocks followed by the degree of dilution, making use of the symbols of the pharmacopoeia used in relation to the homoeopathic manufacturing procedure described therein for that stock or stocks.

2.  The name and address of the holder of the certificate of registration and, where different, the name and address of the manufacturer.

3.  The method of administration and, if necessary, route.

4.  The expiry date of the product in clear terms (stating the month and year).

5.  The pharmaceutical form.

6.  The contents of the sales presentation.

7.  Any special storage precautions.

8.  Any special warning necessary for the product concerned.

9.  The manufacturers batch number.

10.  The registration number allocated by the licensing authority preceded by the letters “HR” in capital letters.

11.  The words “homoeopathic medicinal product without approved therapeutic indications”.

12.  A warning advising the user to consult a doctor if the symptoms persist during the use of the product.