Preparation and maintenance of comprehensive documentation on pharmacovigilance systems for all marketed products.
PSMF is a legal requirement in the UK, EU and many other countries across the world and is applicable to any authorized medicinal product approved in the territory. MAHs need to maintain and have the readiness to submit a summary of information on pharmacovigilance systems to the competent authorities.
PSMF Process
SentinelRX have implemented a comprehensive, risk-based process that utilizes standardized templates and checklists to guarantee data accuracy and completeness, in accordance with regulatory requirements.
This process also integrates various systems and assesses their impact on the Pharmacovigilance System Master File (PSMF) through a well-coordinated and meticulously cross-referenced linkage system. This approach ensures thorough coverage of the pharmacovigilance system during the preparation of the PSMF.
SentinelRX has a dedicated PSMF team that works under close supervision of the respective QPPVs. The team consists of highly trained individuals with multiple years of PSMF management experience for the EU, UK, and ROW.
PSMF/National PSMF for Rest of World (ROW)
Recently, many ROW countries such as Gulf Cooperation Council (GCC) nations (Arab countries) and Eurasian Economic Union (EAEU) countries have started requesting PSMF/National PSMF.
National PSMF/National pharmacovigilance sub-system file (PSSF/PvSF) shall describe the key elements of pharmacovigilance activities at the national level in the local country concerned. The national PSSF shall be maintained in a current state and be permanently available to the local QPPV.