My HPRA: Register

Find Forms and Applications

Title File Type File Size Published Date  
Suspected Unexpected Serious Adverse Reaction Report (SUSAR) Form for Investigator Led Trials .docx 111 KB 09/06/2022 View more information
Notification of substantial modification of a clinical investigation of a medical device .docx 83 KB 08/06/2022 View more information
Request for performance study pre-submission meeting .docx 103 KB 19/05/2022 View more information
Application for a performance study .docx 126 KB 17/05/2022 View more information
Annual Communication to Registration of Manufacturer, Importer or Distributor of Active Substances .docx 113 KB 25/04/2022 View more information
Application for a Parallel Import Licence - Human Medicines .docx 110 KB 07/04/2022 View more information
Application for Addition of a Source Country to a Parallel Import Licence .docx 77 KB 07/04/2022 View more information
Variation or Immediate Notification of Change to Registration of Manufacturer, Importer or Distributor of Active Substances .docx 109 KB 07/03/2022 View more information
Application for a Parallel Traded Veterinary Product Authorisation .docx 107 KB 02/03/2022 View more information
Application for a Registration Certificate for Veterinary Medicinal Product for pets under Article 5(6) of Regulation 2019/6 .docx 106 KB 18/02/2022 View more information
Application for Registration of Category 2 Scheduled Substances (Precursor Chemicals) .docx 114 KB 07/02/2022 View more information
Application for Registration of Category 3 Scheduled Substances (Precursor Chemicals) .docx 110 KB 07/02/2022 View more information
Application for Export Authorisation for Scheduled Substances .docx 106 KB 07/02/2022 View more information
Application for Licence for Category 1 Scheduled Substances (Precursor Chemicals) .docx 119 KB 07/02/2022 View more information
Application for certificates of free sale for in vitro diagnostic medical devices compliant with IVDR .docx 106 KB 04/02/2022 View more information
IMP expedited assessment of variations to Annex 3 and or 4 application form .docx 131 KB 31/01/2022 View more information
IMP immediate notification of variations to Annex 3 and or 4 application form .docx 128 KB 31/01/2022 View more information
Application for a Wholesale Distribution Authorisation .docx 116 KB 31/01/2022 View more information
Application to vary a wholesale distribution authorisation .docx 120 KB 31/01/2022 View more information
Application for Registration of Manufacturer, Importer or Distributor of Active Substances .docx 112 KB 28/01/2022 View more information
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