Application Forms for Medicines Registration

• 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 Market Authorization 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 Information Summary (QIS), March, 2024 Download
• Quality Information Summary (QIS), March, 2024 Download
• 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