Clause 4 Flashcards
4.1 How must the prescribing information listed in clause 4.1 be provided and in what?
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).
4.1 How must the prescribing information be positioned?
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.
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 audio- visual 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.
4.2 What can be provided instead of i-viii within the prescribing information?
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 In addition, the non-proprietary name of the medicine or a list of the active ingredients using approved names where such exist must appear where?
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 non- proprietary name or list of active ingredients occupies a total area no less than that taken up by the brand name.
4.3 For electronic advertisements the non-proprietary name of the medicine or the list of active ingredients, as required by Clause 4.3, must appear where?
Immediately adjacent to the brand name at its first appearance in a size such that the information is readily readable.
4.4 In the case of digital material such as advertisements in electronic journals, emails, electronic detail aids and suchlike, the prescribing information as required by Clause 4.1 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 the case of audio-visual material 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.
4.6 In the case of promotional material included on the Internet, where should the prescribing information me?
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.
4.7 In the case of a printed journal advertisement where the prescribing information appears overleaf, where should the prescribing information reference be?What size font?
In the case of a printed 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 page 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 Promotional material other than advertisements appearing in professional publications include?
Promotional material other than advertisements appearing in professional publications must include the date on which the promotional material was drawn up or last revised.
4.9 All promotional material must include what prominent statement?
All promotional material must include the prominent statement ‘Adverse events should be reported. forms and information can be found at [web 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 show an inverted black equilateral triangle, what does this denote?
It denotes that additional monitoring is required in relation to adverse reactions.
