Guidelines for Monitoring Safety of Medicines and Vaccines
The Tanzania Medicines and Medical Devices; National Guidelines for Monitoring Medicines safety came into effect in November, 2010. The document provides guidance for reporting ADRs by marketing authorization holders (MAH); health care providers; and patients.
It also includes requirements for expected reporting, reporting medication errors, product quality defects, overdoses and unusual lack of efficacy as well as the roles and responsibilities of different stakeholders in monitoring medicines safety in Tanzania. In addition, it defines what needs to be reported, how, by who and when.
It should be noted that adverse events due to medicines, herbal medicines and medical devices authorized for clinical trials involving human participants pursuant to Sections 61 to 72 of the Tanzania Food, Drugs and Cosmetics Act, No.1 of 2003 are not within the scope of these guidelines.