The Human Medicines Regulations 2012

Regulations 294, 295 and 297

SCHEDULE 30 Particulars for advertisements to persons qualified to prescribe or supply

1.  The number of the marketing authorisation, certificate of registration, traditional herbal registration or Article 126a authorisation for the medicinal product.

2.  The name and address of the holder of the marketing authorisation, certificate of registration, traditional herbal registration or Article 126a authorisation for the medicinal product or the business name and address of the part of the holder’s business that is responsible for its sale or supply.

3.  The classification of the medicinal product as—

(a) a product that is subject to general sale;

(b) a prescription only medicine; or

(c) a pharmacy medicine.

4.  The name of the medicinal product.

5.  A list of the active ingredients of the medicinal product that uses their common names and is placed immediately adjacent to the most prominent display of the name of the product.

6.  One or more of the indications for the medicinal product consistent with the terms of the marketing authorisation, certificate of registration, traditional herbal registration or Article 126a authorisation for the product.

7.  A succinct statement of the entries (if any) in the summary of the product characteristics relating to—

(a) adverse reactions, precautions and relevant contra-indications;

(b) dosage and method of use so far as relevant to the indications shown in the advertisement, and

(c) where this is not obvious, method of administration so far as relevant to those indications.

8.  The cost excluding value added tax of—

(a) a specified package of the medicinal product; or

(b) a specified quantity or recommended daily dose of the medicinal product calculated by reference to a specified package of the medicinal product.

This paragraph does not apply to an advertisement inserted in a publication that is printed in the United Kingdom but that has a circulation outside the United Kingdom of more than 15 per cent of its total circulation.

9.—(1) The particulars specified in paragraph 7 must be printed in a clear and legible manner.

(2) Those particulars must 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.