If a second medicine is mentioned in promotional material for another medicine does the prescribing information for both need to be provided?

  • Clause 12 Arrangements for Changes to the Marketing Authorisation Number and the Marketing Authorisation Holder Name and Address Following Changes Resulting from the UK Leaving the EU

    For the period from 1 January 2021 until 1 January 2023, a complaint that the prescribing information for a previously centrally approved medicine does not have the new marketing authorisation number or any new marketing authorisation holder’s name and address as required by Clause 12.2 (vii) will not be considered to be in breach of that clause and potentially any other relevant clause provided that:

    • other changes to the prescribing information have not been needed

    • the prescribing information includes the previous information about the marketing authorisation number and

    • any new marketing authorisation holder can be contacted via the address given in the prescribing information.

    This will also apply to medicines (other than those centrally approved) if the marketing authorisation numbers and marketing authorisation holder name and address are changed from 1 January 2021 as a result of the departure of the UK from the EU.

  • Clause 12.1 (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 promotional 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.

  • Clause 12.1 (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.

  • Clause 12.1 (4.1) Prescribing Information on Printed Material and Reference to Online Current Regulatory Documents

    In addition to including prescribing information, companies are encouraged to include references on printed materials to an online resource where the current regulatory documents for each medicine promoted can be found.

  • Clauses 12.1 and 12.8 (4.1 and 4.8) Date of Prescribing Information and Promotional Material

    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 12.2 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 created or last revised.

  • Clause 12.1 (4.1) Advertisements in 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 prominent, direct, single click 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 so 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 it in a size 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 that symbol must appear adjacent to the product name (see Clause 12.10). The size must be such that it would not be easily overlooked. The requirement of Clause 15.6 that promotional material and activities must not be disguised should also be borne in mind.

  • Clause 12.1 (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. However, if particular medicines are referred to, then the prescribing information for each must be provided.

  • Clause 12.1 (4.1) Prescribing Information at Exhibitions

    The prescribing information for medicines promoted on posters and exhibition panels at events/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.

  • Clause 12.2 (4.2) Use of the Summary of Product Characteristics

    The Code defines prescribing information to consist of three parts: the legal classification, the cost and other elements (listed as i-viii) in Clause 12.2. Where space in printed material is not an issue, elements i-viii can be provided by reproducing the summary of product characteristics. With an electronic advertisement, elements i-viii could be provided by a prominent, direct single click link to the summary of product characteristics (Clause 12.4 and its supplementary information). It would not be acceptable to provide a website address for the summary of product characteristics on printed material as a means of meeting the requirements to provide elements i-viii.

  • Clause 12.3 (4.3) Non-Proprietary Name

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

    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.

  • Clause 12.4 (4.4) Use of Links for Prescribing Information

    When digital material includes 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 or 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.

  • Clause 12.5 (4.5) Prescribing Information on Audiovisual Material

    Where prescribing information is shown on audiovisual 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 promotional content and must appear with it. It is not acceptable for the promotional content and the prescribing information to be separated by any other material.

  • Clauses 12.1 and 12.8 (4.1 and 4.8) Date of Prescribing Information and Promotional Material

    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 12.2 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 created or last revised.

  • Clause 12.8 (4.8) Date Created or Last Revised

    This is in addition to the requirement in Clause 12.2 that the date of the prescribing information be included.

  • Clause 12.8 (4.8) 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 created or last revised.

  • Clause 12.9 (4.9) 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.

    In the event that the website address required in Clause 12.9 is changed by the Medicines and Healthcare products Regulatory Agency (MHRA), companies must use the new address within one year of the change.

  • Clause 12.10 (4.10) Black Triangle Symbol

    The black triangle symbol is also required 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. Obligatory explanatory wording is also required on these documents.

If both medicines are the company’s then prescribing information for each should be included. If the second medicine is a competitor medicine, or a medicine which is not the company's, then prescribing information for that medicine does not need to be provided.