Application Forms for Medicines Registration

• Sameness Declaration Form for Reliance-Based Evaluation, July, 2025 Download
• Summary of Quality and Bioequivalence Review template-Verification of the Sameness filled by the Applicant, July, 2025 Download
• Applicant’s Consent to Share Product Assessment Reports Download
• Declaration Letter for the Sameness Download
• Summary of quality and bioequivalence review - verification of the sameness form Download
• Quality Information Summary (QIS) Download
• Application for a Biowaiver Additional Strength Download
• Application for a Biowaiver Biopharmaceutics Classification System (BCS) Download
• List of Documents Governing Medicines Revies Process Download
• Applicant’s Self-Screening Checklist Before Submission of Application for Marketing Authorization of Human Medicinal Product Download
• Applicant’s consent to share Assessment and Inspection reports with NMRA's Download
• Application Form for Marketing Authorization of Herbal Medicinal Product Download
• Application Form for Approval of Promotional Materials Download
• Application form for registration of Medicinal Product Download
• Application for Marketing Authorization of Veterinary Medicinal Products Download
• Application for Variation of a Registered Medicinal Product in Tanzania Download
• Application Form for Change of Local Agents (Local Technical Representatives) Download
• Application Form of New Application for Registration of Antiseptic and Disinfectants Download
• Application Form for Variation of Registration of Antiseptics Disinfectants Download
• Application Form for Variation of Vaccines Download