Medicine Registration Guidelines

  • Compendium Guidelines for Marketing Authorization of Medicinal Products Download
  • Guidelines on Submission of Documentation for Marketing Authorization of Herbal Medicinal Products Download
  • Guidelines for Submission of Documentation for Marketing Authorization of Biocidals (Antiseptics and Disinfectants) Products, August 2020. Download
  • Guidance for Production of Alcohol-Based Hand Sanitizers Under Public Health Emergency Preparedness, April 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 Marketing Authorization of Human Vaccines, March 2020. Download
  • Guidelines on Variations on Registered Medicinal Products, March 2020. Download
  • Guidelines on Submission of Documentation for Renewal of Registration of Human and Veterinary Pharmaceutical Products, March 2020. Download
  • The Tanzania Medicines and Medical Devices (Good Manufacturing Practice Enforcement) Regulation,2018 Download