Application Forms for Medicines Registration
| Summary of Quality and Bioequivalence Review Template-Verification of the Sameness filled by the Applicant, July, 2025 | Download |
| Sameness Declaration Form for Reliance-Based Evaluation, July, 2025 | Download |
- Applicant consent to share unredacted assessment reports, July, 2025 Download
- Applicant Self Screening Checklist Before Submission of Application for Registration to TMDA, July, 2022 Download
- Application For Marketing Authorization for Human Vaccines, July, 2022 Download
- Application Form for a Biowaiver- Additional Strength, March, 2024 Download
- Applicant consent to share Assessment and Inspection reports with NRA, August, 2022 Download
- Application Form For Approval of Promotional and Advertisments of Medicines, October, 2022 Download
- Application Form for a Biowaiver- Biopharmaceutics Classification System (BCS), March, 2024 Download
- Application form for Marketing Authorisation of Vertenary Medicinal Product, October, 2022 Download
- Application form for Marketing Authorisation of Human Medicinal Product, October, 2022 Download
- Application Form for Marketing Authorisation of Herbal Medical Products, October, 2022 Download
- Application Form for Trade Fair Permit, October, 2022 Download
- Application form for Renewal of Registration of Antiseptics Disinfectants, October, 2022 Download
- Application Form for Variation of Vaccines,October, 2022 Download
- Application form for Variation of Registered Human Medicinal Product, October, 2022 Download
- Application form of New application for Registration Antiseptic and Disinfectants, October, 2022 Download
- Application form_Change of Local Technical Representatives, October, 2022 Download
- Bioequivalence Trial Information Form, April, 2024 Download
- List of Documents Governing Medicines Review Process, April, 2025 Download
- Quality Overall Summary (QOS), April, 2024 Download
- Quality Information Summary (QIS), March, 2024 Download