Clause 4 - Prescribing Information and Other Obligatory Information

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 separate summary of product characteristics is not sufficient to conform with the provisions of this clause.

There may be instances where reproducing the summary of product characteristics will not be an acceptable way to fulfill the requirement for prescribing information. For example, Clause 6.1 limits advertising in journals for a particular product to two pages.

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

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.

If the summary of product characteristics is not used then the date that the prescribing information was last drawn up or last revised must be included (Clause 4.2 viii).

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

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 4.10). 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.

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.

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.

The Code defines prescribing information to consist of three parts, the legal classification, the cost and other elements (listed as i-viii) in Clause 4.2. In certain situations elements i-viii can be provided by the summary of product characteristics. However, in some circumstances, elements i-viii will have to be provided either as described in Clause 4.2 or by reproducing the summary of product characteristics. Where there are issues of space on printed material, for example a journal advertisement, then elements i-viii will probably have to be provided as a summary. Where there is no issue of space – perhaps a detail aid, elements i-viii could be provided by reproducing the summary of product characteristics. With an electronic advertisement elements i-viii could be provided by a link to the summary of product characteristics (Clause 4.4 and its supplementary information). It would not be acceptable to provide a website address for the summary of product characteristics on a printed journal advertisement as a means of meeting the requirements to provide elements i-viii.

‘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.

When digital material provides the reader with a link to prescribing information on another website then such a link should only be included for use when the material is generally expected to be viewed online, for example, advertisements in electronic journals, emails, electronic detail aids when used remotely and the like. This is to ensure that at the time of reading the link is active and will provide readers with the necessary information. When material is more likely to be viewed offline, such as electronic detail aids to be used by representatives when visiting health professionals, then the requisite information must be provided as part of the item itself or as a link that does not require the reader to be online.

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.

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

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.

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.

In the event that the website address required in Clause 4.9 is changed by the Medicines and Healthcare products Regulatory Agency, companies must use the new address within one year of the change.

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.

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 readable.

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.