Do risk minimisation materials need prescribing information?

See supplementary information to Clause 1.17 Risk Minimisation Plans and Materials.

Prescribing information must be provided in a clear and legible manner in all promotional material for a medicine. If a company cannot demonstrate that the material is approved as risk management material, which is part of its pharmacovigilance obligations, then it should consider the material to be promotional and prescribing information will be needed.