Clause 12 Prescribing Information and Other Obligatory Information
(4.1) The prescribing information listed in Clause 12.2 must be provided in a clear and legible manner in all promotional material for a medicine except for abbreviated advertisements (see Clause 13). The prescribing information must be positioned for ease of reference and must not be presented in a manner such that the reader has to turn the material round in order to read it, for example, by providing it diagonally or around the page borders. The prescribing information must form part of the promotional material and must not be separate from it.
2 (4.2) The prescribing information consists of the following:
• the legal classification of the product
• the cost (excluding VAT) of either a specified package of the medicine to which the advertisement relates, or a specified quantity or recommended daily dose, calculated by reference to any specified package of the product, except in the case of advertisements in journals printed in the UK which have more than 15 per cent of their circulation outside the UK and audiovisual advertisements and prescribing information provided in association with them
i) the name of the medicine (which may be either a brand name or a non-proprietary name)
ii) a quantitative list of the active ingredients, using approved names where such exist, or other non-proprietary names; alternatively, the non-proprietary name of the product if it is the subject of an accepted monograph
iii) at least one authorised indication for use consistent with the summary of product characteristics
iv) a succinct statement of the information in the summary of product characteristics relating to the dosage and method of use relevant to the indications quoted in the advertisement and, where not otherwise obvious, the route of administration
v) a succinct statement of common adverse reactions likely to be encountered in clinical practice, serious adverse reactions and precautions and contra-indications relevant to the indications in the advertisement, giving, in an abbreviated form, the substance of the relevant information in the summary of product characteristics, together with a statement that prescribers should consult the summary of product characteristics in relation to other adverse reactions
vi) 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
vii) the number of the relevant marketing authorisation and the name and address of the holder of the authorisation or the name and address of the part of the business responsible for its sale or supply
viii) the date the prescribing information was drawn up or last revised.
The summary of product characteristics may be provided instead of i-viii above.
If the summary of product characteristics is not used, then the information specified above in relation to iv, v and vi which is required to be included in advertisements, must be placed in such a position in the advertisement that its relationship to the claims and indications for the product can be appreciated by the reader.
(4.3) 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. For electronic advertisements, the non-proprietary name of the medicine or the list of active ingredients, as required by Clause 12.3, must appear immediately adjacent to the brand name at its first appearance in a size such that the information is easily readable.
(4.4) In digital material such as advertisements in electronic journals, emails, electronic detail aids and suchlike, the prescribing information as required by Clause 12.1 may be provided either:
• by inclusion in the digital material itself, or
• by way of a clear, and prominent, direct, single click link.
(4.5) In audiovisual material and in interactive data systems, the prescribing information may be provided either:
• by way of a document which is made available to all persons to whom the material is shown or sent, or
• by inclusion on the audiovisual recording or in the interactive data system itself.
When the prescribing information is included in an interactive data system, instructions for accessing it must be clearly displayed.
(4.6) Promotional material provided on the internet must include a clear prominent statement as to where the prescribing information can be found.
(4.7) In a printed journal advertisement the prescribing information must appear on at least one of the pages. The pages where the prescribing information is not visible must include a reference on the outer edge of the page as to where the prescribing information can be found in a type size such that a lower case ‘x’ is no less than 2mm in height.
(4.8) Promotional material other than advertisements in professional publications must include the date on which the promotional material was created or last revised.
(4.9) All promotional material 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]’.
(4.10) When required by the licensing authority, all promotional material must clearly show an inverted black equilateral triangle to denote that additional monitoring is required in relation to adverse reactions. The symbol should always be black, and its size should normally be not less than 5mm per side but with a smaller size of 3mm per side for A5 size advertisements and a larger size of 7.5mm per side for A3 size advertisements.
The symbol should appear once and be located adjacent to the most prominent display of the name of the product.
No written explanation of the symbol is necessary.
Digital communications are also covered by this requirement, and the black triangle symbol should be located adjacent to the first mention of the product as this is likely to be considered the most prominent display of the name of the product. The size must be such that it is easily noticed.