Table 2.

Other territories: authors’ experience of Pharmacovigilance System Master File (PSMF)-type documents required by local legislation

Document type	Description
Country/regional PSMF	Follows the same format as the EU PSMF but the content includes country/regional and global information on the PV system
Country/regional Pharmacovigilance Sub-System File (PSSF)	Describes the key elements of PV activities in the country concerned and is submitted alongside the PSMF
Detailed Description of the Pharmacovigilance System (DDPS)	Based on Volume 9A of the Rules Governing Medicinal Products in the European Union: Guidelines on Pharmacovigilance for Medicinal Products for Human Use requirements
	Provides a description of the system with requirements for listings and compliance data
Summary of the Pharmacovigilance System (SPS)	Terminology that, in the Authors’ experience, may have different meanings in different countries/regions. For example:
	a document based on EU GVP Module II requirements (proof of the applicant’s QPPV, residency and contact details of the QPPV, location of the PSMF and a signed statement that the applicant has the necessary means to fulfil the tasks and responsibilities listed in Title IX), or
	a simple descriptive written summary of the PV System within a company
EU PSMF	Accepted where there are strong similarities with EU legislation/GVP. Of note, consideration should be given to the applicability of the EU PSMF content (e.g., responsibilities of the EU QPPV outside of this region)

EU European Union, GVP good pharmacovigilance practices, PV pharmacovigilance, QPPV Qualified Person for Pharmacovigilance