Clause 16 Material and Distribution

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Clause 16
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16.1

Promotional material about prescription only medicines directed to a UK audience which is provided on the internet must comply with all relevant requirements of the Code.

  • Clause 16.1 Website Access

    Unless access to promotional material about prescription only medicines is limited to health professionals and other relevant decision makers, a pharmaceutical company website or a company sponsored website must provide information for the public as well as promotion to health professionals with the sections for each target audience clearly separated and the intended audience identified. This is to avoid the public needing to access material for health professionals unless they choose to. The MHRA Blue Guide states that the public should not be encouraged to access material which is not intended for them.

16.2

A medicine covered by Clause 16.1 may be advertised in a relevant, independently produced electronic journal intended for health professionals or other relevant decision makers which can be accessed by members of the public.

16.3

Restraint must be exercised on the frequency of distribution and on the volume of promotional material distributed.

  • Clause 16.3 Frequency of Distribution

    The style of materials is relevant to their acceptability and criticism of their frequency is most likely to arise when their informational content is limited.

    Emails can only be sent with the prior permission of the recipient.

16.4

Mailing lists must be kept up-to-date. Requests to be removed from promotional mailing lists must be complied with promptly and no name may be restored except at the addressee’s request or with their permission.

16.5

Reprints of articles in journals must not be provided proactively unless the articles have been peer reviewed.

  • Clause 16.5 Provision of Reprints

    The proactive provision of a reprint of an article about a medicine constitutes promotion of that medicine and all relevant requirements of the Code must therefore be observed. Particular attention must be paid to the requirements of Clauses 12.1 and 12.2.

    When providing a reprint of an article about a medicine, it must be accompanied by prescribing information and adverse event reporting information.