Find Forms and Applications

Title File Type File Size Published Date  
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 71 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
Application for a Variation to a Tissue/Importing Tissue Establishment Authorisation .docx 123 KB 13/11/2020 View more information
Application for Certificates of Free Sale for Medical Devices .docx 106 KB 06/10/2020 View more information
Application for an Export Certificate .docx 113 KB 01/10/2020 View more information
Application to vary a wholesale distribution authorisation .docx 126 KB 01/10/2020 View more information
Application for Transfer of an Authorisation for Manufacturing Investigational Medicinal Products .docx 104 KB 01/10/2020 View more information
Application for Transfer of an Authorisation for Wholesale Medicinal Products for Human Use .docx 106 KB 01/10/2020 View more information
Application for Transfer of an Authorisation for Manufacturing Medicinal Products for Human Use .docx 103 KB 01/10/2020 View more information
Application for Transfer of a Licence for Manufacturing Medicinal Products for Veterinary Use .docx 105 KB 01/10/2020 View more information
Application for a Wholesale Distribution Authorisation .docx 119 KB 01/10/2020 View more information
Application for Reactivation of an Individual Authorisation under Scientific Animal Protection Legislation .docx 112 KB 27/08/2020 View more information
Application for a Change to Labels and/or Patient Information Leaflets not Connected with Changes to the SmPC .docx 108 KB 14/07/2020 View more information
Fee Application Form (Veterinary) .xlsx 59 KB 06/07/2020 View more information