SOP: PV Risk Management Plan (RMP) Management

This template for the Risk Management Plan (RMP) Management SOP supports pharmaceutical and biotechnology companies in establishing a compliant process for the preparation, maintenance, review and submission of Risk Management Plans in accordance with EU pharmacovigilance requirements.
 
The RMP is a key regulatory document that describes how the safety profile of a medicinal product will be monitored and managed throughout its lifecycle. RMPs are required for many Marketing Authorisation Applications (MAA) and must be maintained and updated as new safety information becomes available.
 
The template provides a structured framework covering:
Preparation and maintenance of Risk Management Plans (RMPs)
Roles and responsibilities of the RMP Author, EU-QPPV, Regulatory Affairs and cross-functional stakeholders
Development of initial and updated RMPs
Risk minimisation measures and effectiveness evaluations
Submission and tracking of RMPs
Management of local and country-specific RMP requirements
Archiving and compliance monitoring
 
The document can be easily customised to reflect the company’s products, organisational structure and pharmacovigilance processes.
 
Typical use cases
Preparing Risk Management Plans for EU Marketing Authorisation Applications
Establishing procedures for ongoing RMP maintenance and updates
Supporting compliance with GVP Module V requirements
Defining responsibilities for RMP development, review and approval
Supporting pharmacovigilance inspections and regulatory audits
Ensuring consistent management of product safety risks throughout the product lifecycle
 
Document format
Editable template provided in Word format, allowing easy customization to fit the company’s pharmacovigilance system and regulatory submission documentation.