Table 2.

Regulations for MAHs in Ethiopia, Kenya, Rwanda and Tanzania

Country	Mandatory by law/regulations for MAHs to conduct PMS activities and report ADRs/medicine safety issues	Mandatory for the MAHs to regularly submit PSURs or PBRERs	Mandatory for manufacturers/MAHs to have a QPPV
Ethiopia	✓	✓	X
Kenya	X	X	X
Rwanda	✓	X	X
Tanzania	✓	✓	✓

✓ present, X missing/not available, ADR adverse drug reaction, MAH Marketing Authorization Holder, PBRER Periodic Benefit–Risk Evaluation Report, PMS post-marketing surveillance, PSUR Periodic Safety Update Report, QPPV Qualified Person Responsible for Pharmacovigilance