CRED SMPC 2024

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT Risk management plan (RMP) The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP. An updated RMP should be submitted: • At the request of the European Medicines Agency; • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. [When justified on a proportional risk-based approach, the CHMP could specify the deadline for [All additional risk minimisation measures and their key messages to be added here. The template for this section is included in the Guidance on the format of the risk management plan (RMP) in the EU - in integrated format - Annex 6 - Details of proposed additional risk minimisation activities on the European Medicines Agency website at https://www.ema.europa.eu/human-regulatory/marketing authorisation/pharmacovigilance/risk-management/risk-management-plans). Leave blank if no additional risk minimisation measures are proposed in the RMP.] • •

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[To be filled in only in case a conditional marketing authorisation or marketing authorisation under exceptional circumstances is being applied for.]

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