Guidance documents – medicines for animal use
paul-test
TXT : 29 KB | 11/03/2026Guide to batch specific requests for veterinary medicines
PDF : 215 KB | 22/10/2024 View tracked changesGuide to applications for a variation to a manufacturer's authorisation
PDF : 395 KB | 15/05/2024Guide to applications for a new manufacturer's authorisation
PDF : 344 KB | 15/05/2024Information on applications for a variation to a manufacturer's authorisation is contained in AUT-G0182 Guide to applications for a variation to a manufacturer's authorisation v1
View tracked changesFAQs on processing labelling and package leaflet for VMPs
PDF : 131 KB | 12/05/2024 View tracked changesGuide to product literature standard (PLS) for veterinary medicinal products
PDF : 119 KB | 01/05/2024 View tracked changesGuide to attainment of Qualified Person status in Ireland
PDF : 110 KB | 10/04/2024 View tracked changesGuide to new applications and variations to wholesale distribution authorisations
PDF : 178 KB | 03/04/2024 View tracked changesGuide to quality system for general sale wholesale distributors
PDF : 739 KB | 15/01/2024 View tracked changesJoint HPRA-VMD guide to acceptable texts for joint labelling for VMPs for use in IE and the UK
PDF : 212 KB | 28/09/2023There are only minor changes to this document; therefore, no track changed version has been provided as it would not be helpful.
Guide to refusals and appeals
PDF : 141 KB | 03/07/2023You can write a description here
View tracked changesGuide to clinical field trial licence applications under National Veterinary Legislation
PDF : 208 KB | 15/05/2023 View tracked changesGuide to reporting and investigation of quality defects in human and veterinary medicinal products
PDF : 245 KB | 17/04/2023 View tracked changesHPRA note for non-pharmacy retail advertising of medicines
PDF : 76 KB | 28/07/2022Guide to Definition of a Veterinary Medicinal Product and the Classification Process
PDF : 192 KB | 14/06/2022The guide was substantially changed; thus, the track changes version has not been uploaded.