My HPRA: Register

Find Forms and Applications

Title File Type File Size Published Date  
Self-reporting of non-compliances under scientific animal protection legislation .docx 103 KB 25/08/2021 View more information
Notification of a clinical investigation under Article 82 MDR .docx 115 KB 16/06/2021 View more information
Application for Certificates of Free Sale for Medical Devices (Medical Device Regulation 2017/745) .docx 105 KB 27/05/2021 View more information
Application for Certificates of Free Sale for Medical Devices (Medical Device Directives 90/385/EEC, 93/42/EEC & 98/79/EC) .docx 106 KB 27/05/2021 View more information
Notification of a clinical investigation of a CE marked medical device (Article 74 MDR) .docx 117 KB 20/05/2021 View more information
Non-technical Summary for a Project under Scientific Animal Protection Legislation .xlsx 190 KB 14/05/2021 View more information
Application for variation to a manufacturer's authorisation .docx 172 KB 06/05/2021 View more information
IMP expedited assessment of variations to Annex 3 and or 4 application form .docx 142 KB 06/05/2021 View more information
IMP immediate notification of variations to Annex 3 and or 4 application form .docx 138 KB 06/05/2021 View more information
Regulatory submission query form for human medicines .docx 101 KB 27/04/2021 View more information
Application to Withdraw an Authorisation Licence Approval or Registration .docx 110 KB 20/04/2021 View more information
Application for a Manufacturer's/Importer's Authorisation .docx 178 KB 19/04/2021 View more information
Notification of Marketing Status of Human Medicines .docx 105 KB 15/04/2021 View more information
Notification of Withdrawal of Authorisations or Certificates for Human Medicines .docx 103 KB 15/04/2021 View more information
Notification of advisory board meeting .docx 105 KB 02/03/2021 View more information
Request for clinical investigation pre-submission meeting .docx 108 KB 23/02/2021 View more information
Batch-Specific Requests for Human Medicines .docx 108 KB 21/01/2021 View more information
Adverse Reaction Report Form For COVID-19 Vaccines .docx 74 KB 22/12/2020 View more information
Notification of One-Off (Non-Routine) Import/Export of Tissues and Cells for Human Application .docx 111 KB 13/11/2020 View more information
Application for a New/Importing Tissue Establishment Authorisation .docx 129 KB 13/11/2020 View more information
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