Medicines Guidelines

• Guidelines for Emergency Use Authorization of Medicinal Products, April, 2023 Download
• Guidelines for Control of Promotion and Advertisement of Medicines, Medical Devices and Cosmetics in Tanzania, 2015 Download
• Guidelines on Submission of Documentation for Renewal of Marketing Authorization of Human and Veterinary Medicinal Products, January 2021 Download
• Guidelines on Variations on Registered Medicinal Products, March 2020. Download
• Guidelines on Submission of Documentation For Marketing Authorization of Human Vaccines, 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 Similar Biotherapeutics Products, March 2020. Download
• Guidelines on Submission of Documentation for Registration of Veterinary Medicinal Products, March 2020. Download
• Guidelines on Submission of Documentation for Registration of Immunological Veterinary Products, March 2020 Download
• 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 (Antiseptics and Disinfectants) Products, August 2020. Download
• Guidelines on Submission of Documentation for Marketing Authorization of Herbal Medicinal Products Download
• Compendium Guidelines for Marketing Authorization of Medicinal Products Download
• Quality Information Summary (QIS) Download
• Guidelines on Variations of Registered Vaccines Download
• Guidelines for Emergency Use Authorization of Medicinal Products, September, 2022 Download
• Guidelines on Processing of Applications for Registration of Medicinal Products through Non-Routine Procedure, April, 2023 Download
• Guidelines on Good Review Practices, April, 2023 Download