Medicines Registration Regulations

This page provides a list of regulations that may be needed by applicants for the preparation of their application for marketing authorization with the Tanzania Medicines and Medical Devices Authority (TMDA).

  • Tanzania Medicines and Medical Devices (Fees and Charges) Regulations, GN No. 686, 2021. Download
  • The Tanzania Food, Drugs and Cosmetics (Scheduling of Medicines) Regulations, GN No. 63, 2015. Download
  • Tobacco Products (Regulations) (Designation of Inspectors) Notice, GN No. 360, 2021. Download
  • The Tanzania Medicines and Medical Devices (Orphan Medicines) Regulations, GN No. 412, 2018. Download
  • The Tanzania Medicines and Medical Devices (Registration of Medicinal Products) Regulations, GN No. 314, 2015. Download
  • The Tanzania Medicines and Medical Devices (Control of Drugs and Herbal Drugs Promotion) Regulations, GN No. 159, 2010. Download