Clause 4 - Prescribing Information and Other Obligatory Information

Clause

4.1 The prescribing information listed in Clause 4.2 must be provided in a clear and legible manner in all promotional material for a medicine except for abbreviated advertisements (see Clause 5).

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.

  • Clause 4.1 Prescribing Information and Summaries of Product Characteristics

    Each promotional item for a medicine must be able to stand alone. For example, when a ‘Dear Doctor’ letter on a medicine is sent in the same envelope as a brochure about the same medicine, each item has to include the prescribing information. It does not suffice to have the prescribing information on only one of the items. The inclusion of a summary of product characteristics moreover does not suffice to conform with the provisions of this clause.

    The prescribing information must be consistent with the summary of product characteristics for the medicine

  • Clause 4.1 Legibility of Prescribing Information

    The prescribing information is the essential information which must be provided in promotional material. It follows therefore that the information must be given in a clear and legible manner which assists readability. Legibility is not simply a question of type size. The following recommendations will help to achieve clarity:

    • type size should be such that a lower case ‘x’ is no less than 1 mm in height
    • lines should be no more than 100 characters in length, including spaces
    • sufficient space should be allowed between lines to facilitate easy reading
    • a clear style of type should be used
    • there should be adequate contrast between the colour of the text and the background
    • dark print on a light background is preferable
    • emboldening headings and starting each section on a new line aids legibility.
  • Clauses 4.1 and 4.9 Date of Prescribing Information and Promotional Material

    All prescribing information must include the date that the prescribing information was drawn up or last revised.

    In addition, promotional material (other than journal advertising) must include the date that the material as a whole, ie the copy plus the prescribing information, was drawn up or last revised.

  • Clause 4.1 Electronic Journals

    The first part of an advertisement in an electronic journal, such as the banner, is often the only part of the advertisement that is seen by readers. It must therefore include a clear, prominent statement as to where the prescribing information can be found. This should be in the form of a direct link. The first part is often linked to other parts and in such circumstances the linked parts will be considered as one advertisement.

    If the first part mentions the product name then this is the most prominent display of the brand name and 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. The size must be such that the information is easily readable. If the product is one that is required to show an inverted black equilateral triangle on its promotional material then the black triangle symbol must also appear adjacent to the product name (see Clause 4.11). The size must be such that it is easily readable. The requirement of Clause 12.1 that promotional material and activities must not be disguised should also be borne in mind.

  • Clause 4.1 Advertisements for Devices

    Where an advertisement relates to the merits of a device used for administering medicines, such as an inhaler, which is supplied containing a variety of medicines, the prescribing information for one only need be given if the advertisement makes no reference to any particular medicine.

    Full prescribing information must, however, be included in relation to each particular medicine which is referred to.

  • Clause 4.1 Prescribing Information at Exhibitions

    The prescribing information for medicines promoted on posters and exhibition panels at meetings must either be provided on the posters or panels themselves or must be available at the company stand. If the prescribing information is made available at the company stand, this should be referred to on the posters or panels.

4.2 The prescribing information consists of the following:

  • the name of the medicine (which may be either a brand name or a non-proprietary name)
  • a quantitative list of the active ingredients, using approved names where such exist, or other nonproprietary names; alternatively, the non-proprietary name of the product if it is the subject of an accepted monograph
  • at least one authorized indication for use consistent with the summary of product characteristics
  • 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
  • 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
  • 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 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
  • the legal classification of the product
  • the number of the relevant marketing authorization and the name and address of the holder of the authorization or the name and address of the part of the business responsible for its sale or supply
  • the date the prescribing information was drawn up or last revised.

The information specified above in relation to dosage, method of use, adverse reactions, precautions and contraindications and any warning 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 In addition, 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 nonprprietary name or list of active ingredients occupies a total area no less than that taken up by the brand name.

  • Clause 4.3 Non-Proprietary Name

    ‘Immediately adjacent to…’ means immediately before, immediately after, immediately above or immediately below.

    It should be noted that in a promotional letter the most prominent display of the brand name will usually be that in the letter itself, rather than that in prescribing information provided on the reverse of the letter.

4.4 In the case of audio-visual material such as films, DVDs and suchlike and in the case of 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 audio-visual 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.

  • Clause 4.4 Prescribing Information on Audio-Visual Material

    Where prescribing information is shown in the audio-visual material as part of the recording, it must be of sufficient clarity and duration so that it is easily readable. The prescribing information must be an integral part of the advertisement and must appear with it. It is not acceptable for the advertisement and the prescribing information to be separated by any other material.

4.5 In the case of audio material, ie material which consists of sound only, the prescribing information must be provided by way of a document which is made available to all persons to whom the material is played or sent.

4.6 In the case of promotional material included on the Internet, there must be a clear, prominent statement as to where the prescribing information can be found. In the case of an advertisement included in an independently produced electronic journal on the Internet, there must be a clear and prominent statement in the form of a direct link between the first page of the advertisement and the prescribing information.

The non-proprietary name of the medicine or the list of active ingredients, as required by Clause 4.3, must appear immediately adjacent to the brand name at its first appearance in a size such that the information is readily readable.

4.7 In the case of a journal advertisement where the prescribing information appears overleaf, at either the beginning or the end of the advertisement, a reference to where it can be found must appear on the outer edge of the other page of the advertisement in a type size such that a lower case ‘x’ is no less than 2mm in height.

4.8 In the case of printed promotional material consisting of more than four pages, a clear reference must be given to where the prescribing information can be found.

4.9 Promotional material other than advertisements appearing in professional publications must include the date on which the promotional material was drawn up or last revised.

  • Clause 4.9 Date Drawn Up or Last Revised

    This is in addition to the requirement in Clause 4.2 that the date of the prescribing information be included.

  • Clause 4.9 Dates on Loose Inserts

    A loose insert is not regarded for this purpose as appearing in the professional publication with which it is sent and must therefore bear the date on which it was drawn up or last revised.

4.10 All promotional material must include the prominent statement ‘Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to [relevant pharmaceutical company]’.

  • Clause 4.10 Adverse Event Reporting

    A telephone number or email address for the relevant department of the company may be included. Text is more likely to be deemed to be prominent if it is presented in a larger type size than that used for the prescribing information.

4.11 When required by the licensing authority, all promotional material must show an inverted black equilateral triangle to denote that additional monitoring is required in relation to adverse reactions.

  • Clause 4.11 Black Triangle Symbol

    The agreement between the then Committee on Safety of Medicines and the ABPI on the use of the black triangle is that:

    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.

    Summaries of product characteristics and package leaflets are excluded from the definition of ‘promotion’ in the Code by Clause 1.2. However it should be noted that EU legislation now requires the black triangle symbol to appear on summaries of product characteristics and on package leaflets. The size of the black triangle on these documents has to be proportionate to the font size of the subsequent text with a minimum length of 5mm per side. The EU requirements do not apply to promotional material. Obligatory explanatory wording is also required.

Interactive 2014 Code