Submission of a RMP update

Procedure for a stand-alone submission of an RMP update (e.g. after expiry of the PSUR obligation)

According to Chapter 7 of the Guide RMP ICH E2E Information Submission HMP, an updated RMP (risk management plan) must be submitted in the event of adjustments to the additional pharmacovigilance measures, reclassifications of the safety concerns, etc. The RMP update must be submitted with the application. If this RMP update is not directly related to another application where the update can be submitted or if the PSUR obligation has expired, the RMP update must be submitted as a stand-alone application. As an RMP update is not included in the form "Variations and extensions HMV4", the RMP update is submitted with a cover letter only (description of the application: "AMS RMP update") including a tracking table. No further Module 1 documents are required. The application can be submitted electronically via the Swissmedic portal or alternatively as a CD. If the electronic submission is made via eCTD, the application type "psur" must be selected in the eCTD Manager for the creation of the sequence. Similarly, the delivery type "psur" must be selected for submission on the Swissmedic portal. The fees are calculated according to the time and effort involved and usually range from CHF 1000.- to 2000.-. The deadlines correspond to those of the PSUR (1 month formal control; 5 months Evaluation I).

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Dr. Katharina Oehler
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