Ethiopian Pharma co-vigilance Guideline 2014

Medicines are one of the most essential components in the health care system. This indisputable fact
makes rational selection, procurement, distribution, and use of medicines of paramount importance in
health care. Worldwide, numerous numbers of drugs are being released into the market every day with
incomplete knowledge as to their safety levels when used by wide variety of population category other
than the one studied in the limited clinical trials making safety of medicines as one important concern.
This concern calls for a Comprehensive pharmacovigilance system.
Hence a complete pharmacovigilance system needs an up to date and practical guideline to provide
information and guidance to the various partners of pharmacovigilance as to what their roles and
responsibilities should be towards the maintenance of a national drug safety.