Guidance documents – medicines for animal use

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

PDF : 228 KB | 27/07/2025

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

PDF : 273 KB | 20/07/2025 View tracked changes

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

PDF : 393 KB | 28/02/2025 View tracked changes

Guide to applications for a new manufacturer's authorisation

PDF : 344 KB | 28/02/2025 View tracked changes

Guide to fees for veterinary products

PDF : 194 KB | 02/01/2025 View tracked changes

FAQs on processing labelling and package leaflet for VMPs

PDF : 131 KB | 12/05/2024 View tracked changes

Guide to product literature standard (PLS) for veterinary medicinal products

PDF : 119 KB | 01/05/2024 View tracked changes

Guide to attainment of Qualified Person status in Ireland

PDF : 110 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 : 212 KB | 28/09/2023

Guide to Parallel Trade - Veterinary Medicines

PDF : 358 KB | 28/09/2023 View tracked changes

Guide to refusals and appeals

PDF : 141 KB | 03/07/2023 View tracked changes

Guide to clinical field trial licence applications under National Veterinary Legislation

PDF : 291 KB | 15/05/2023 View tracked changes

Guide to invented names of veterinary medicines

PDF : 91 KB | 18/07/2022 View tracked changes

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

PDF : 192 KB | 14/06/2022

Guide to Transfers of Veterinary Marketing Authorisations and Applications

PDF : 271 KB | 28/04/2022 View tracked changes

Guide to decentralised and mutual recognition procedures for veterinary medicinal products

PDF : 593 KB | 17/02/2022 View tracked changes

Guide to electronic submissions - veterinary medicines

PDF : 272 KB | 07/02/2022 View tracked changes

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

PDF : 281 KB | 28/01/2022 View tracked changes

Guide to registration requirements for active substances manufacturers importers and distributors in Ireland

PDF : 2523 KB | 28/01/2022 View tracked changes

Guide to registration of homeopathic veterinary medicinal products

PDF : 421 KB | 26/01/2022 View tracked changes