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Title File Type File Size Published Date  
Guide to scientific and regulatory advice for GXP activities .pdf 218 KB 06/10/2017 View more information
Guide to Transfers of Marketing Authorisations, Parallel Import Licences and Dual Pack Import Registrations for Human Medicines .pdf 158 KB 19/09/2017 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
Guide to Import and Export Licences and Letters of No Objection for Controlled Drugs .pdf 235 KB 02/05/2017 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 EU Clinical Trial Application Form .pdf 152 KB 21/12/2016 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 Labels and Leaflets of Human Medicines .pdf 391 KB 03/05/2016 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 Wholesaling and Brokering of Medicinal Products for Human Use in Ireland .pdf 194 KB 15/01/2016 View more information
Guide to Invented Names of Human Medicines .pdf 207 KB 07/12/2015 View more information
Guide to Biosimilars for Healthcare Professionals and Patients .pdf 310 KB 04/12/2015 View more information
Guide to applying for a manufacturer's or importer's authorisation .pdf 294 KB 23/09/2015 View more information
Guide to Good Manufacturing Practice of Cosmetic Products .pdf 265 KB 27/08/2015 View more information
Guide to Clinical Trial Applications .pdf 309 KB 29/06/2015 View more information