Ethiopia Pharmacovigilance guidelines
Ethiopia Pharmacovigilance guidelines
In September 2020, Ethiopian Food and Drug Authority issued Pharmacovigilance Directive in accordance with Article 71 sub article (2) of the Ethiopian Food and Medicine Administration Proclamation No 1112/2019.
In accordance with article 38,2 of the proclamation, any MAH shall report periodic safety update report, Individual case safety report and establish Risk management plans for its products in line with the national standards as follows
Ethiopia Pharmacovigilance guidelines
- Serious adverse drug events should be reported within /48 hours and, unexpected and expected must be reported as soon as possible but no later than 15 calendar days of initial receipt of the information by the MAH. Efforts must be taken to send a report that is complete.
- Non-serious adverse drug events must be sent within 90 days after the granted knowledge of the event.
- All suspected serious adverse drug events in post-registration studies should be reported according to the timelines given in this article sub article 1 & 2 of the previous section
- For new medicines that are registered and placed in the market in the country, a Periodic Safety Update Report should be submitted to the authority every 6 months for the first two years after market approval and there after annually for three years.
- If no adverse drug events have been received by the market authorization holder, it is obliged to submit a “Null” report, i.e., a report stating that it has not received any adverse drug event reports on their medicinal product.
- Follow the International Birth date (IBD) and also follow ICH guidelines for PSUR/PBRER submission.
- The market authorization holder should also inform the Authority of any significant safety issue (from other than single case reports) or action taken by foreign agency, including the bases for such action within 3 working days days of first knowledge by the market authorization holder.
- Information on withdrawal of the registration status in any country because of safety issue must be noted to the Authority within 24 hours of the first knowledge by the market authorization holder.
- For every ICSR, MAH should report a fully completed data
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