Medicine Registration Guidelines

• Guidelines on Variations on Registered Medicinal Products, March 2020 Download
• Guideline on Good Review Practices 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
• Quality Information Summary (QIS) 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
• 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