Regulations for Pharmacovigilance
The Tanzania Medicines and Medical Devices (Pharmacovigilance) Regulations, 2018 which came into effect in 2018, is the biggest milestones toward regulation of safety of human and veterinary pharmaceutical products in the Tanzania.
It has significant requirements that demand applicants and marketing authorization holders of medicines to submit to the Authority; Periodic Safety Updates Reports, Periodic Benefits and Risks Evaluation Reports, Risk Management Plans as well as Individual Case Safety Reports of their Products circulating in the Market amongst others.
It also lays down the requirements for healthcare professionals, patients or consumers for reporting adverse drug reactions and events.
- The Tanzania Medicines and Medical Devices (Pharmacovigilance) Regulations, 2018. Download