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Title File Type File Size Published Date  
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
Guide to Good Manufacturing Practice of Cosmetic Products .pdf 265 KB 27/08/2015 View more information
Guide to Combining Multiple Presentations of a Parenteral Product in One Product Authorisation .pdf 229 KB 30/03/2015 View more information
Guide to Parallel Imports - Veterinary Medicines .pdf 194 KB 24/03/2015 View more information
Guide to PharmaTrust Extranet .pdf 359 KB 13/03/2015 View more information
Guide to Display of Chemical Group Symbols on Product Literature of Sheep Anthelmintics .pdf 67 KB 19/01/2015 View more information
Clarification Paper on Joint Labelling between IE and UK 09.01.2015 .pdf 265 KB 15/01/2015 View more information
Guide to Reporting Serious Adverse Reactions (SARs) and Serious Adverse Events (SAEs) associated with Human Tissues and Cells .pdf 253 KB 26/11/2014 View more information
Guide to Registration of Homeopathic Veterinary Medicinal Products .pdf 203 KB 11/11/2014 View more information
Guide to Registration of Homeopathic Medicinal Products .pdf 390 KB 11/11/2014 View more information
Guide to Submitting a Request for Ireland to Act as RMS in a DCP for Human Medicines .pdf 156 KB 29/10/2014 View more information
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