ISO 9001: 2015: CERTIFIED

PUBLIC NOTICE

25^th September, 2022

Submission of Appointment of Qualified Person for PharmacoVigilance (QPPV)

1. Tanzania Medicines and Medical Devices Authority (TMDA) wishes to inform our esteemed customers that in line with Section 8(1), 11, 12 and 24 of the Tanzania Medicines and Medical Devices (Pharmacovigilance) Regulations, 2018, Market Authorization Holders (MAHs) are required to establish a functioning pharmacovigilance system and appoint a Qualified Person for PharmacoVigilance (QPPV) to oversee it.
2. The system will be used for receiving, handling, evaluating and reporting Adverse Drug Reactions (ADRs) of their products.
3. In light of the above, you are required to submit appointment letters, curricula vitae as well as copies of qualification certificates of the appointed personnel as QPPV. Proof of initial and continued training as QPPV should also be submitted.
4. The requested documents should be sent to the Authority by e-mail through info@tmda.go.tz or submitted physically to the address below, not later than two weeks from the date of this notice.
5. We thank you for your continued cooperation.