Clause 13 Abbreviated Advertisements
13.1
Abbreviated advertisements are exempt from the requirement to include prescribing information for the advertised medicine, provided that they are limited in size and content as set out in this clause.
13.2
Abbreviated advertisements may only appear in professional publications, i.e. publications sent or delivered wholly or mainly to members of the health professions and/or other relevant decision makers. A loose insert in such a publication cannot be an abbreviated advertisement.
Abbreviated advertisements may contain only the information specified in Clauses 13.4, 13.5, 13.6, 13.7 and 13.8.
Abbreviated advertisements are not permitted in audiovisual material or in interactive data systems or on the internet, including journals on the internet.
13.3
Abbreviated advertisements must be no larger than 420 square centimetres in size.
13.4
Abbreviated advertisements must provide the following information in a clear and legible manner:
• the name of the medicine (which may be either a brand name or a non-proprietary name)
• the non-proprietary name of the medicine or a list of the active ingredients using approved names where such exist
• at least one indication for use consistent with the summary of product characteristics
• the legal classification of the product
• any warning issued by the Medicines Commission, the Commission on Human Medicines, the Committee on Safety of Medicines or the licensing authority which is required to be included in advertisements
• the name and address of the marketing authorisation holder or the name and address of the part of the business responsible for the medicine’s sale or supply
• the statement: ‘Information about this product, including adverse reactions, precautions, contraindications and method of use can be found at [the address of the website referred to below]' and state that prescribers are recommended to consult the summary of product characteristics before prescribing.
The website referred to above must provide either:
• the information set out in Clauses 12.2 and 12.4 (except that the non-proprietary name of the medicine or the list of active ingredients, as required by Clause 12.4, must appear immediately adjacent to the most prominent display of the brand name in a size such that the information is easily readable and information about cost, as required by Clause 12.2, need not be included on the website where the abbreviated advertisement appears only in journals printed in the UK which have more than 15 per cent of their circulation outside the UK), or
• the summary of product characteristics.
13.5
The non-proprietary name of the medicine or a list of the active ingredients using approved names where such exist must appear immediately adjacent to the most prominent display of the brand name in bold type of a size such that a lower case ‘x’ is no less than 2mm in height or in type of such a size that the non-proprietary name or list of active ingredients occupies a total area no less than that taken up by the brand name.
13.6
Abbreviated advertisements must include the prominent statement ‘Adverse events should be reported. Reporting forms and information can be found at [website address which links directly to the MHRA Yellow Card site]. Adverse events should also be reported to [relevant pharmaceutical company]’.
13.7
When required by the licensing authority, abbreviated advertisements must clearly show an inverted black equilateral triangle to denote that additional monitoring is required in relation to adverse reactions.
It should be borne in mind that abbreviated advertisements must be no larger than 420 square centimetres in size. In abbreviated advertisements of no more than 310.8 square centimetres (A5), each side of the triangle should be no less than 3mm. In abbreviated advertisements larger than A5 (but no larger than 420 square centimetres) each side should be no less than 5mm. The other relevant requirements of Clause 12.7 apply equally to the use of the black triangle symbol on abbreviated advertisements.
13.8
Abbreviated advertisements may contain a concise statement consistent with the summary of product characteristics, giving the reason why the medicine is recommended for the indication or indications given.
13.9
Marketing authorisation numbers and references must not be included in abbreviated advertisements.