Medicines Registration Guidelines

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

  • Guidelines on Submission of Documentation for Marketing Authorization of Human Vaccines, March 2020 Download
  • Guidelines for Emergency Use Authorization of Medicinal Products, September, 2022 Download
  • Guidelines on Good Review Practices, September, 2022 Download
  • Guidelines on Variations on Registered Medicinal Products, March 2020 Download
  • Guidelines On Submission of Documentation for Marketing Authorization of Herbal Medicinal Products Download
  • Guidelines on Submission of Documentation for Renewal of Marketing Authorization of Human and Veterinary Medicinal Products, January 2021 Download
  • Guidelines on Variations of Registered Vaccines Download
  • Compendium Guidelines for Marketing Authorization of Medicinal Products Download
  • Guidelines for Submission of Documentation for Marketing Authorization of Biocidals (Antiseptics and Disinfectants) Products, August 2020. Download
  • Guidelines on Submission of Documentation for  Registration of Immunological Veterinary Products, March 2020. Download
  • Guidelines on Submission of Documentation for Registration of Veterinary Medicinal Products, March 2020. Download
  • Guidelines for Control of Promotion and Advertisement of Medicines, Medical Devices and Cosmetics in Tanzania, First Edition, January 2015. Download
  • Guidelines on Submission of Documentation For Marketing Authorization of Similar Biotherapeutics Products, March 2020. Download
  • Guidelines on Submission of Documentation for Marketing Authorization of Biotherapeutics Products, March 2020. Download
  • Guidelines on Submission of Documentation for Renewal of Registration of Human and Veterinary Pharmaceutical Products, March 2020. Download