Risk Management Plans

Cover Note to List of safety concerns per approved Risk Management Plan (RMP) of active substances per product (April 2021) [Track version]

Annex 1: Form for providing list of safety concerns for approved RMPs/updates to list

Annex 2: HaRP (Harmonisation of RMP Project) - methodology of harmonising RMPs (April 2021) [Track version]

List of safety concerns per approved Risk Management Plan (RMP) of active substances per product (October 2023, correction February 2024)
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The update of the CMDh List of safety concerns per approved Risk Management Plan (RMP) of active substances per product is currently delayed.
A new technical, database-driven solution is under development by CMDh.

Flow chart on the assessment and procedure for adoption by CMDh of HaRP Assessment reports prepared by the HaRP Peer Review Group (February 2021)