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Title File Type File Size Published Date  
Guide for National Scientific and Regulatory Advice .pdf 134 KB 20/09/2023 View more information
Guide to Parallel Imports - Human Medicines .pdf 303 KB 12/07/2023 View more information
Guide to Reporting Serious Adverse Reactions (SARs) and Serious Adverse Events (SAEs) associated with Human Tissues and Cells .pdf 247 KB 29/06/2023 View more information
Guide to clinical trials conducted under the CTR in Ireland .pdf 394 KB 28/06/2023 View more information
Joint HPRA-VMD guide to acceptable texts for joint labelling for veterinary medicinal products for use in IE and the UK .pdf 233 KB 13/06/2023 View more information
Guide to Serious Adverse Reaction/Event Reporting for Human Organs Intended for Transplantation .pdf 179 KB 19/05/2023 View more information
Guide to Clinical Field Trial Licence Applications under National Veterinary Legislation .pdf 208 KB 16/05/2023 View more information
Guide to Reporting and Investigation of Quality Defects in Medicinal Products for Human and Veterinary Use .pdf 245 KB 04/05/2023 View more information
Guide to Fees for Human Products .pdf 289 KB 19/04/2023 View more information
Endorsed document on Non-technical Project Summaries .pdf 1 MB 06/03/2023 View more information
Guide to Registration of Processes Exempted under Article 61(5) of the Clinical Trial Regulation .pdf 124 KB 02/02/2023 View more information
Guide to Fees for Veterinary Products .pdf 203 KB 31/01/2023 View more information
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 Fees for Scientific Animal Protection .pdf 82 KB 03/01/2023 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
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