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Title File Type File Size Published Date  
Guide to Submitting a Request for Ireland to Act as RMS in a DCP for Human Medicines .pdf 77 KB 03/04/2024 View more information
Guide to Submitting a Request for a New National Application Procedure for a Human Medicinal Product .pdf 74 KB 03/04/2024 View more information
Guide to Renewal of Marketing Authorisations - Human Medicines .pdf 121 KB 14/03/2024 View more information
Guide to Reporting Serious Adverse Reactions (SARs) and Serious Adverse Events (SAEs) associated with Human Tissues and Cells .pdf 251 KB 09/02/2024 View more information
Guide to Fees for Human Products .pdf 256 KB 02/01/2024 View more information
Guide to Fees for Veterinary Products .pdf 203 KB 02/01/2024 View more information
Guide to Fees for Scientific Animal Protection .pdf 82 KB 02/01/2024 View more information
Guide to Invented Names of Veterinary Medicines .pdf 92 KB 01/12/2023 View more information
Technical guidance for completion of non-technical project summaries under scientific animal protection legislation .pdf 128 KB 02/11/2023 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 212 KB 20/10/2023 View more information
Guide to Refusals and Appeals under Scientific Animal Protection Legislation .pdf 168 KB 05/10/2023 View more information
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 clinical trials conducted under the CTR in Ireland .pdf 394 KB 28/06/2023 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
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 Clinical Trial Applications .pdf 255 KB 26/01/2023 View more information