Document Management

Veterinary Medicine Forms and Formats

Doc. No Title Version Last Update Download
DFAR/VMDAR/FOM/006 Application Form for Market Authorization of Veterinary Medical Devices and /or In Vitro Diagnostics Devices (IVDDs) 1 13/09/2023 Download
DFAR/VMDAR/FOM/007 Application Form to Variation of a Registered Veterinary Medicinal Product 1 13/09/2023 Download
DFAR/VMDAR/CKL/003 Checklist for Conditional Approval of Veterinary Devices 1 13/09/2023 Download
DD/VMDR/FOM/004 Quality Overall Summary (QOS) for Veterinary Biological Products 2 30/06/2025 Download
DD/VMDR/FMT/011 SUMMARY OF PRODUCT CHARACTERISTICS 1 30/06/2025 Download
DD/VMDR/FMT/012 CONTAINER LABELING FORMAT 2 30/06/2025 Download
DD/VMDR/FMT/016 PRODUCT INFORMATION LEAFLET (PIL) FORMAT 1 30/06/2025 Download
DD/VMDR/FOM/003 Quality Overall Summary (QOS) for Immunological Veterinary Products 2 30/06/2025 Download
DD/VMDR/FMT/014 SUMMARY OF PRODUCT CHARACTERISTICS 1 30/06/2025 Download
DD/VMDR/FMT/015 CONTAINER LABELING 1 30/06/2025 Download
DD/VMDR/FMT/017 PRODUCT INFORMATION LEAFLET (PIL) 1 30/06/2025 Download
DD/VMDR/FOM/002 APPLICATION FORM FOR A NEW MARKETING AUTHORISATION FOR VETERINARY PHARMACEUTICAL, BIOLOGICAL AND IMMUNOLOGICAL PRODUCTS 2 30/06/2025 Download
DD/VMDR/FMT/018 QAULITY OVERALL SUMMARY (QOS) - VMP 1 30/06/2025 Download
DD/VMDR/FMT/019 QUALITY INFORMATION SUMMARY - VMP 1 30/06/2025 Download
DD/VMDR/FMT/020 LETTERS OF ACCESS TO APIMF 1 30/06/2025 Download
DD/VMDR/FMT/021 CERTIFICATE OF SUITABILITY TO THE MONOGRAPHS OF THE EUROPEAN PHARMACOPOEIA 2 30/06/2025 Download
DD/VMDR/FMT/022 PRESENTATION OF BIOEQUIVALENCE TRIAL INFORMATION 1 30/06/2025 Download
DD/VMDR/FMT/022-BTIF BIOWAIVER APPLICATION FORM 1 30/06/2025 Download
DD/VMDR/FMT/023 CONTAINER LABELLING 1 30/06/2025 Download
DD/VMDR/FMT/024 PRODUCT INFORMATION LEAFLET 1 30/06/2025 Download
DD/VMDR/FMT/025 SUMMARY OF PRODUCT CHARACTERISTICS 1 30/06/2025 Download
DD/VMDR/FMT/026 COVER LETTER VMP, IVP, BVP 1 30/06/2025 Download