Find Forms and Applications

Title File Type File Size Published Date  
Application to vary a wholesale distribution authorisation .docx 127 KB 06/12/2018 View more information
Application for a Wholesale Distribution Authorisation .docx 118 KB 06/12/2018 View more information
Application for a Project Authorisation under Scientific Animal Protection Legislation .docx 158 KB 27/11/2018 View more information
Application for a project authorisation under scientific animal protection legislation v8 .docx 129 KB 01/11/2018 View more information
Retrospective Assessment Report for Projects Authorised under Scientific Animal Protection Legislation .docx 104 KB 22/10/2018 View more information
Request for Ireland to Act as RMS in an MR or DC procedure for veterinary medicinal products .docx 64 KB 18/10/2018 View more information
Non-technical Project Summary for a Project under Scientific Animal Protection Legislation .docx 102 KB 17/10/2018 View more information
Notification of medicinal product shortage from marketing authorisation holder .docx 110 KB 12/10/2018 View more information
Notification of Marketing Status of Human Medicines .docx 103 KB 11/10/2018 View more information
Batch-Specific Requests for Human Medicines .docx 108 KB 28/09/2018 View more information
Cosmetics RAPEX reaction report v5 .docx 100 KB 13/08/2018 View more information
Fee Application Form for Human Products .xlsx 79 KB 26/06/2018 View more information
Expedited assessment application for variation to Annex 3 or 4 of an IMP authorisation v1 .docx 134 KB 22/06/2018 View more information
Application Form A for Transfer of an Authorised (Parallel) or DPR Product .docx 105 KB 09/05/2018 View more information
Application Form A for Transfer of a Veterinary Marketing Authorisation .docx 106 KB 12/04/2018 View more information
Application for a Renewal of an Individual Authorisation under Scientific Animal Protection legislation .docx 104 KB 13/12/2017 View more information
Designation of Notified Bodies - Application Documentation Index Form .docx 102 KB 20/11/2017 View more information
Declaration of Completeness of Application Form .docx 54 KB 20/11/2017 View more information
Application for a Change to Labels and/or Patient Information Leaflets not Connected with Changes to the SmPC .docx 106 KB 01/09/2017 View more information
Quality defect report .docx 101 KB 18/07/2017 View more information