Table 3.

Modifications to the EU Pharmacovigilance System Master File (PSMF)^a

Modification type	Survey result
Provision of EU PSMF main body text, Sections 2–7	4
Reorganisation of EU PSMF annexes and/or provision of specific local annexes	4
Removal of reference to EU-specific information	3
Provision of some EU PSMF annexes (global information)	3
Provision of a company-developed template based on EU PSMF	2
No EU PSMF annexes provided	2
Creation of specific local section 1 for main body text	1

a Where information provided, n = 9

EU European Union