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Title File Type File Size Published Date  
Medicines shortages framework .pdf 712 KB 14/09/2018 View more information
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
Guide to Fees for Human Products .pdf 420 KB 26/06/2018 View more information
Guide to Clinical Trial Applications .pdf 335 KB 21/06/2018 View more information
HPRA Brexit Guidance - Human and Veterinary Medicines .pdf 320 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 labels and leaflets of human medicines .pdf 394 KB 07/11/2017 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 for National Scientific and Regulatory Advice .pdf 231 KB 17/07/2017 View more information
Guide to Reclassification (Switching) of Legal Supply Status for Human Medicinal Products .pdf 281 KB 06/07/2017 View more information
Guide to Placing Medical Device Standalone Software on the Market .pdf 306 KB 21/06/2017 View more information
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