My HPRA: Register

Find Forms and Applications

Title File Type File Size Published Date  
Adverse Reaction Report Form For COVID-19 Vaccines .docx 81 KB 26/09/2024 View more information
Notification of veterinary medicinal product shortage from marketing authorisation holder .docx 68 KB 28/05/2024 View more information
Fee Application Form for Human Products .xlsx 85 KB 02/01/2024 View more information
Fee Application Form (Veterinary) .xlsx 60 KB 02/01/2024 View more information
Fee Application Form (Scientific Animal Protection) .xlsx 99 KB 02/01/2024 View more information
Application for import authorisation for scheduled substances .docx 71 KB 03/11/2023 View more information
Request for National Scientific and Regulatory Advice .docx 108 KB 20/09/2023 View more information
Application for Certificates for free sale for devices qualifying under Regulation 2023-607 .docx 74 KB 09/08/2023 View more information
Application for an Amendment and/or Renewal to a Project Authorisation under Scientific Animal Protection Legislation .docx 90 KB 24/07/2023 View more information
Application for Addition of a Source Country to a Parallel Import Licence .docx 80 KB 12/07/2023 View more information
Application for a Parallel Import Licence - Human Medicines .docx 73 KB 12/07/2023 View more information
Application for Dual Pack Import Registration .docx 82 KB 12/07/2023 View more information
Pre-submission request for a national application or for Ireland to act as RMS in a DC/MR/SR procedure for veterinary medicinal products .docx 112 KB 29/06/2023 View more information
Serious Adverse Reaction/Event Report Form - Human Tissues and Cells .docx 77 KB 29/06/2023 View more information
Batch-Specific Requests for Human Medicines .docx 109 KB 29/05/2023 View more information
Serious Adverse Reaction Event Report Form for Human Organs intended for Transplantation .docx 109 KB 19/05/2023 View more information
Application for a clinical investigation of non CE-marked medical devices (Article 62 MDR) .docx 98 KB 10/03/2023 View more information
Article 97 Request Form .docx 115 KB 10/02/2023 View more information
Application for register for exemption .docx 106 KB 02/02/2023 View more information
Request for pre-submission meeting for MIA .docx 68 KB 01/02/2023 View more information
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