Risk minimisation measures
Risk minimization measures (RMM) are interventions intended to prevent, or reduce the occurrence of adverse reactions associated with the exposure to a medicine, or to reduce their severity, or impact on the patient should adverse reactions occur.
There are routine and additional risk minimization measures:
- Examples of routine risk minimization measures are information provided in the summary of product characteristics, or on the packaging of a medicine, such as information on the packaging size, pharmaceutical form, or dispensing mode (prescription or non-prescription).
- Examples of additional risk minimization measures are educational materials (brochures, guides, cards, etc.), controlled access to medicines, pregnancy prevention programmes, direct healthcare professional communication, etc.
Additional risk minimization measures
Marketing authorisation holder is responsible for the implementation of additional risk minimisation measures. The purpose of additional risk minimization measures is to provide important information about a specific risk associated with the use of the medicine. Educational materials that are part of additional risk minimization measures must not have a promotional character, but their content refers exclusively to safe use of the medicine. Additional risk minimization measures may be intended for healthcare professionals (doctors, pharmacists, nurses…), or patients and their carers.
Educational materials distributed in Montenegro as part of additional risk minimization measures are available in the table below. In order to save time and resources, educational materials approved by the Agency for Medicines and Medical Devices of Serbia (ALIMS) and Agency for Medicinal Products and Medical Devices of Croatia (HALMED), in Serbian, i.e. Croatian, may be distributed in Montenegro, with corrected contact details.
|Naziv lijeka||INN||Edukativni materijal za zdravstvene radnike||Edukativni materijal za pacijente|
|Alunbrig||brigatinib||Alunbrig-Kartica za pacijenta v.1|
|Arava||leflunomid||Arava-Brosura za ljekare v.2||Arava-Brosura za pacijente v.2|
|Aubagio||teriflunomid||Aubagio-Vodic za propisivace v.2||Aubagio-Kartica za pacijenta v.2-1|