Guidance documents – medicines for animal use

Guide to implementation of packaging changes to authorised veterinary medicinal products

PDF : 177 KB | 03/03/2026 View tracked changes

Guide to Transfers of Veterinary Marketing Authorisations and Applications

PDF : 132 KB | 03/03/2026 View tracked changes

Guide to joint-labelling for veterinary medicinal products for use in Ireland and the UK

PDF : 145 KB | 27/02/2026 View tracked changes

FAQs on processing labelling and package leaflet for VMPs

PDF : 134 KB | 27/02/2026 View tracked changes

Guide to preparation of Mock ups for Veterinary Medicinal Products

PDF : 167 KB | 27/02/2026 View tracked changes

Guide to registration of homeopathic veterinary medicinal products

PDF : 301 KB | 13/02/2026 View tracked changes

Guide to fees for veterinary products

PDF : 261 KB | 02/01/2026 View tracked changes

Guide to refusals and appeals

PDF : 204 KB | 17/09/2025 View tracked changes

Guide to Registration of VMPs for pets that qualify for registration under Article 5(6) of Regulation 2019-6

PDF : 233 KB | 27/07/2025 View tracked changes

Guide to reporting and investigation of quality defects in human and veterinary medicinal products

PDF : 277 KB | 20/07/2025 View tracked changes

Guide to clinical field trial licence applications under National Veterinary Legislation

PDF : 295 KB | 25/03/2025 View tracked changes

Guide to applications for a variation to a manufacturer's authorisation

PDF : 398 KB | 28/02/2025 View tracked changes

Guide to applications for a new manufacturer's authorisation

PDF : 348 KB | 28/02/2025 View tracked changes

Guide to attainment of Qualified Person status in Ireland

PDF : 114 KB | 10/04/2024 View tracked changes

Joint HPRA-VMD guide to acceptable texts for joint labelling for VMPs for use in IE and the UK

PDF : 216 KB | 28/09/2023 View tracked changes

Guide to invented names of veterinary medicines

PDF : 133 KB | 18/07/2022 View tracked changes

Guide to Definition of a Veterinary Medicinal Product and the Classification Process

PDF : 196 KB | 14/06/2022

Guide to electronic submissions - veterinary medicines

PDF : 276 KB | 07/02/2022 View tracked changes

Guide to Parallel Trade - Veterinary Medicines

PDF : 362 KB | 28/01/2022 View tracked changes

Guide to managing changes to registration for active substance manufacturers importers and distributors

PDF : 285 KB | 28/01/2022 View tracked changes