Find Forms and Applications

Title File Type File Size Published Date  
Batch-Specific Requests for Veterinary Medicines .docx 66 KB 26/09/2014 View more information
Variation or Immediate Notification of Change to Registration of Manufacturer, Importer or Distributor of Active Substances .docx 72 KB 28/08/2014 View more information
Application for an Amendment/Renewal to a Breeder/Supplier/User Authorisation under Scientific Animal Protection Legislation .docx 111 KB 20/08/2014 View more information
Application for Withdrawal of a Breeder/Supplier/User Authorisation under Scientific Animal Protection Legislation .docx 60 KB 14/08/2014 View more information
Retrospective Assessment Report for Projects Authorised under Scientific Animal Protection Legislation .docx 65 KB 11/07/2014 View more information
Statement of Licensing Status of Pharmaceutical Product .docx 29 KB 09/07/2014 View more information
Notification of Marketing Status of Human Medicines .docx 65 KB 02/07/2014 View more information
Annual Update to Registration of Manufacturer, Importer or Distributor of Active Substances .docx 114 KB 01/07/2014 View more information
Batch-Specific Requests for Human Medicines .docx 65 KB 25/06/2014 View more information
Notification of Withdrawal of Authorisations or Certificates for Human Medicines .docx 65 KB 24/06/2014 View more information
Application for a Project Authorisation under Scientific Animal Protection Legislation .docx 129 KB 19/06/2014 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
Non-technical Project Summary for a Project under Scientific Animal Protection Legislation .docx 102 KB 19/06/2014 View more information
Adverse Reaction Report Form for Human Medicines .docx 73 KB 09/06/2014 View more information
Serious Adverse Reaction Event Report Form for Human Organs intended for Transplantation .docx 107 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 104 KB 09/06/2014 View more information
Suspected Unexpected Serious Adverse Reaction Report (SUSAR) Form for Investigator Led Trials .docx 75 KB 09/06/2014 View more information
Quality Defect and Recall Card .docx 54 KB 09/06/2014 View more information