My HPRA: Register

Find Forms and Applications

Title File Type File Size Published Date  
Statement of Licensing Status of Pharmaceutical Product .docx 29 KB 09/07/2014 View more information
Annual Update to Registration of Manufacturer, Importer or Distributor of Active Substances .docx 114 KB 01/07/2014 View more information
Submissions of Risk Minimisation and Educational Materials for MAH .docx 60 KB 19/06/2014 View more information
Application Form to be Submitted when Applying for Designation as a Notified Body .docx 70 KB 19/06/2014 View more information
Adverse Reaction Report Form for Human Medicines .docx 108 KB 09/06/2014 View more information
Serious Adverse Reaction Event Report Form for Human Organs intended for Transplantation .docx 140 KB 09/06/2014 View more information
DHPC Submission Form for Marketing Authorisation Holders .docx 65 KB 09/06/2014 View more information
Undesirable effect report form for cosmetic products .docx 105 KB 09/06/2014 View more information
Suspected Unexpected Serious Adverse Reaction Report (SUSAR) Form for Investigator Led Trials .docx 108 KB 09/06/2014 View more information
Quality Defect and Recall Card .docx 54 KB 09/06/2014 View more information
Serious Adverse Reaction/Event Report Form - Human Tissues and Cells .docx 106 KB 09/06/2014 View more information
Medical Device Incident User Report Form .docx 106 KB 09/06/2014 View more information
Regulatory Affairs Contact Information .pdf 1 MB 09/06/2014 View more information
Blood Establishment Annual Activity Report .docx 114 KB 09/06/2014 View more information
Annual Compliance Assessment Report for General Sale Wholesale Distributors .docx 68 KB 09/06/2014 View more information
Hospital Blood Bank Annual Report Appendix 1 .docx 77 KB 09/06/2014 View more information
Notification of Non-Routine Import-Export of Tissues and Cells for Human Application .docx 71 KB 09/06/2014 View more information
Tissue Establishment Annual Report for Reproductive Tissues and Cells .docx 72 KB 09/06/2014 View more information
Tissue Establishment Annual Report .docx 67 KB 09/06/2014 View more information
Fee Application Form (Scientific Animal Protection) .xlsx 99 KB 09/06/2014 View more information
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