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Title File Type File Size Published Date  
Guide to Transfers of Marketing Authorisations, Parallel Import Licences and Dual Pack Import Registrations for Human Medicines .pdf 160 KB 31/07/2018 View more information
Guide to Electronic Transmission of SUSARs associated with the use of Human Medicines .pdf 267 KB 20/07/2018 View more information
HPRA Brexit Guidance - Human and Veterinary Medicines - Update 26 April 2019 .pdf 279 KB 01/06/2018 View more information
Guide to Interchangeable Medicines .pdf 224 KB 31/05/2018 View more information
Guide to the Notification System for Exempt Medicinal Products .pdf 358 KB 23/05/2018 View more information
Guide to Appeals Under Cosmetic Product Legislation .pdf 109 KB 15/05/2018 View more information
Guide to Transfers of Veterinary Marketing Authorisations and Applications .pdf 162 KB 12/04/2018 View more information
Guide for distributors of medical devices .pdf 181 KB 14/02/2018 View more information
Guide to Clinical Trials Regulation (EU) No.536(2014) Pilot project - Ireland .pdf 546 KB 14/12/2017 View more information
Guide to Notified Bodies Designation Process .pdf 293 KB 20/11/2017 View more information
Guide to Electronic Submissions - Medical Devices .pdf 235 KB 20/11/2017 View more information
Guide to scientific and regulatory advice for GXP activities .pdf 218 KB 06/10/2017 View more information
Guidance Note on the Sale of Paracetamol-containing Medicinal Products by Non-pharmacy Retailers .pdf 184 KB 27/07/2017 View more information
Guide to Placing Medical Device Standalone Software on the Market .pdf 460 KB 21/06/2017 View more information
Guide to Parallel Imports - Human Medicines .pdf 414 KB 03/02/2017 View more information
Guide to submission of mock-ups for variations to veterinary products .pdf 567 KB 23/01/2017 View more information
Guide to Electronic Submissions - Human Medicines .pdf 189 KB 15/07/2016 View more information
Guide to Information held by the HPRA .pdf 460 KB 14/07/2016 View more information
Guide to Serious Adverse Reaction/Event Reporting for Human Organs Intended for Transplantation .pdf 531 KB 21/01/2016 View more information
Guide to Invented Names of Human Medicines .pdf 207 KB 07/12/2015 View more information