Publications

• Guidance for Production of Alcohol-Based Hand Sanitizers Under Public Health Emergency Preparedness, April 2020. Download
• Guidelines for Submission of Documentation for Marketing Authorization of Biocidals (Antiseptic and Disinfectant) Products, First Edition, February 2015 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 Registration of Human Pharmaceutical Products, First Edition, January 2015. Download
• Guidelines on Submission of Documentation for Renewal of Registration of Human and Veterinary Pharmaceutical Products, March 2020. Download
• Guideline on Submission of Documentation for Marketing Authorization of Herbal Medicinal Products, Second Edition, February 2017. Download
• Guidelines on Therapeutic Equivalence Requirements,First Edition, January 2015. Download
• Guidelines on Stability Testing Requirements for Active Pharmaceutical Ingredients (APIs) and Finished Pharmaceutical Products (FPPs), First Edition, January 2015. Download