Additional risk minimisation activities (RMA) can be a prerequisite to market authorised medicines. RMA can be material to inform healthcare professionals or patients.
Examples
- A brochure that provides additional explanations about the symptoms of possible side effects, how the patient can recognise them and how the patient should deal with them; or provides additional explanations on how to use a medicine (e.g. how to give yourself an injection at home).
- A warning card, which is a card that the patient should always carry and show to doctors/nurses, as it contains important information about the treatment.
More information
Information for professionals: approved RMA materials
Information for industry: RMA guidelines
Questions?
rma@fagg-afmps.be