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21.09.2022

All GCC countries released in iViReg

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:

  • Local Qualified Person Responsible for Pharmacovigilance (QPPV)
  • The organizational structure of the MAH's local office
  • Sources of safety data
  • Computerized systems and databases
  • Pharmacovigilance processes
  • Pharmacovigilance sub-system performance
  • Quality system
  • Annex to the national PVSF

If you would like to gain more knowledge about PV Regulatory Intelligence in GCC countries, get in touch with iViReg Team at ivireg@ivigee.com or through our website www.ivigee.com.

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