Skip to main content

PSMF Development and Maintenance

The legal requirement for marketing authorisation holders to maintain and make available upon request a pharmacovigilance system master file (PSMF) was introduced into European legislation to harmonise and strengthen the conduct of pharmacovigilance activities in the EU.

The PSMF should describe the pharmacovigilance system and support/document its compliance with the requirements. As well as fulfilling the requirements for a PSMF laid down in the legislation and guidance, it should also contribute to the appropriate planning and conduct of audits by the applicant or marketing authorisations holder(s), the fulfilment of supervisory responsibilities of the QPPV, and of inspections or other verification of compliance by national competent authorities.

The PSMF provides an overview of the pharmacovigilance system, which may be requested and assessed by national competent authorities during marketing authorisation application(s) or post-authorisation.

PhV Services has developed specific procedures and templates for both the Summary of the PV System (which is submitted to the Competent Authorities (CA)) and the Pharmacovigilance System Master File (PSMF) (which is held on file by the MAH for provision on request by the CA). We have also developed specific SOPs for the maintenance of the PSMF.

PSMF Services include the following

1) Provision of PSMF SOPs

2) Development of the PSMF

3) Maintenance of the PSMF


Please call +44 (0)1363 775981, email or click to discuss your requirements.