Guidance documents – medicines for animal use
Guide to applications for a variation to a manufacturer's authorisation
PDF : 395 KB | 15/05/2024
Guide to applications for a new manufacturer's authorisation
PDF : 344 KB | 15/05/2024
Information 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
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FAQs on processing labelling and package leaflet for VMPs
PDF : 131 KB | 12/05/2024
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Guide to product literature standard (PLS) for veterinary medicinal products
PDF : 119 KB | 01/05/2024
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Guide to attainment of Qualified Person status in Ireland
PDF : 110 KB | 10/04/2024
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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 : 208 KB | 15/05/2023
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Guide to reporting and investigation of quality defects in human and veterinary medicinal products
PDF : 245 KB | 17/04/2023
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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
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Guide to Registration of VMPs for pets that qualify for registration under Article 5(6) of Regulation 2019-6
PDF : 383 KB | 18/02/2022
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Guide to decentralised and mutual recognition procedures for veterinary medicinal products
PDF : 593 KB | 17/02/2022
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Guide to electronic submissions - veterinary medicines
PDF : 272 KB | 07/02/2022
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Guide to managing changes to registration for active substance manufacturers importers and distributors
PDF : 281 KB | 28/01/2022
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