Marketing authorisation holders are obliged to introduce and update the risk management system (Section 91, Sub-section 1, Letter c) of the Amendment to AoP). Risk management system updates are to be recorded in the risk management plan. Routine (pre-planned) updates of the RMP are submitted according to the time schedule set in the marketing authorisation or together with the submission of the PSUR or the application for the marketing authorisation renewal. Unless an update of the RMP is necessary on the set dates, this information shall be provided in an accompanying letter and it shall not be necessary to submit the RMP. Moreover, the updated RMP must always be submitted upon an occurrence of important information influencing the benefit-risk profile. Details can be found in Chapter V.C.5., Module V of the GVP.
Furthermore, it shall be essential to update the existing RMP that is to say to submit the updated versions of the RMP subject to the new format. The deadline for the submission of the existing approved RMPs in the new format is not known at the time being.
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