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4.9
4.9 All promotional material must include the prominent statement “Adverse events should be reported. Reporting forms and information can be found at [a web address which links directly to the MHRA yellow card site]. Adverse events should also be reported to [relevant pharmaceutical company]”.
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26.3
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 web 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 web address which links directly to the MHRA Yellow Card site] for how to report side effects.’
www.mhra.gov.uk/yellowcard
