My HPRA: Register

Find Forms and Applications

Title File Type File Size Published Date  
Request for Classification of a Human Health Product .docx 110 KB 17/01/2023 View more information
Application for certificates for free sale (IVDD medical devices, up classified and legacy devices) .docx 110 KB 20/12/2022 View more information
Application for an Individual Authorisation under Scientific Animal Protection Legislation .docx 127 KB 23/09/2022 View more information
Application for an Amendment to an Individual Authorisation under Scientific Animal Protection Legislation .docx 120 KB 23/09/2022 View more information
Directive 2022-642 Justifiable case template for inclusion of UK(GB) sites in regulatory submissions for Ireland .docx 70 KB 18/08/2022 View more information
Adverse Reaction Report Form for Human Medicines .docx 110 KB 12/08/2022 View more information
Request for a derogation under Directive 2022-642 .docx 115 KB 22/06/2022 View more information
Notification of a PS for a companion diagnostic under Article 58(2) .docx 116 KB 21/06/2022 View more information
Notification of a PS of a CE marked IVD under Article 70 .docx 120 KB 21/06/2022 View more information
Classification Request for a Project/Study under Scientific Animal Protection Legislation .docx 104 KB 17/06/2022 View more information
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
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
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