Guidance documents – medicines for animal use
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
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 clinical field trial licence applications under National Veterinary Legislation
PDF : 291 KB | 15/05/2023
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 Registration of VMPs for pets that qualify for registration under Article 5(6) of Regulation 2019-6
PDF : 228 KB | 18/02/2022
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