More news in iViReg! PV Regulatory Intelligence for all GCC countries is now released.
Did you know that in the United Arab Emirates Multinational Applicants/MAHs are required to have more than 1 description of their Pharmacovigilance System?
First is the Pharmacovigilance System Master File (PSMF) according to EU GVP and,
second is the National Pharmacovigilance System Master File (PVSF) which describes the key elements of pharmacovigilance activities in the UAE.
The content of the National PVSF is as follows: