Clause 26

26

26.1

(26.1) Prescription only medicines must not be advertised to the public. This prohibition does not apply to vaccination and other campaigns carried out by companies and approved by the health ministers.

26.2

(26.2) Information about prescription only medicines which is made available to the public either directly or indirectly must be factual and presented in a balanced way. It must not raise unfounded hopes of successful treatment or be misleading with respect to the safety of the product.

Statements must not be made for the purpose of encouraging members of the public to ask their health professional to prescribe a specific prescription only medicine.

26.3

(18.2 SI) Items for patient support made available to patients, for example, by completing a request card enclosed with a medicine, should be inexpensive, related to either the condition under treatment or general health, and must be appropriately documented and certified in advance as required by Clause 8.3. Care must be taken that any such activity meets all the requirements of the Code and in particular Clause 26.4.

Companies cannot run or sponsor competitions or quizzes for patients if prizes are offered.

26.4

(26.3) Any material which relates to a medicine and which is intended for patients taking that medicine must include the statement below or a similar one:

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at [a website address which links directly to the MHRA Yellow Card site].

By reporting side effects, you can help provide more information on the safety of this medicine.’

When the material relates to a medicine which is subject to additional monitoring, an inverted black equilateral triangle must be included on it together with the statement below or a similar one:

‘This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See [a website address which links directly to the MHRA Yellow Card site] for how to report side effects.’

26.5

(26.4) Requests from individual members of the public for advice on personal medical matters must be refused and the enquirer recommended to consult their own doctor, or other prescriber or other health professional.