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Title File Type File Size Published Date  
Guide to Clinical Trial Applications .pdf 255 KB 26/01/2023 View more information
Guide to Interchangeable Medicines .pdf 188 KB 23/01/2023 View more information
Guide to Import and Export Licences and LONOs for Controlled Drugs (including the import of cannabis products) .pdf 208 KB 20/12/2022 View more information
Guide to Applications for Certificates of Free Sale for Medical Devices .pdf 221 KB 20/12/2022 View more information
Guide to Reclassification (Switching) of Legal Supply Status for Human Medicinal Products .pdf 222 KB 15/12/2022 View more information
Guide to Clinical Investigations carried out in Ireland .pdf 145 KB 18/11/2022 View more information
Guide to Performance Studies Conducted in Ireland .pdf 175 KB 16/11/2022 View more information
Guide to Product Literature Standard (PLS) for Veterinary Medicinal Products .pdf 123 KB 14/11/2022 View more information
FAQs on Processing the Labelling and Package Leaflet for Veterinary Medicinal Products .pdf 141 KB 14/11/2022 View more information
Guide to appeals under cosmetic product legislation .pdf 90 KB 04/11/2022 View more information
Guide to Use of Animals for Educational Purposes under Scientific Animal Protection Legislation .pdf 129 KB 17/10/2022 View more information
Guide to Batch-Specific Requests for Human Medicines .pdf 118 KB 13/10/2022 View more information
HPRA note for non-pharmacy retail advertising of medicines .pdf 77 KB 29/07/2022 View more information
Guide to definition of a veterinary medicinal product and the classification process .pdf 193 KB 15/06/2022 View more information
Guide to Wholesaling and Brokering of Medicinal Products for Human Use in Ireland .pdf 343 KB 25/03/2022 View more information
Guide to Registration of Veterinary Medicinal Products for pets that qualify for registration under Article 5(6) of Regulation 2019/6 .pdf 383 KB 18/02/2022 View more information
Guide to Labels and Leaflets of Human Medicines .pdf 565 KB 09/02/2022 View more information
Guide to Electronic Submissions - Veterinary Medicines .pdf 273 KB 07/02/2022 View more information
Guide to New Applications and Variations to Wholesale Distribution Authorisations .pdf 178 KB 31/01/2022 View more information
Guide to Managing Changes to Registration for Active Substance Manufacturers, Importers and Distributors .pdf 281 KB 28/01/2022 View more information
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