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Title File Type File Size Published Date  
Notification of a clinical investigation of a CE marked medical device (Article 74 MDR) .docx 118 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
Regulatory submission query form for human medicines .docx 101 KB 27/04/2021 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
Application for Transfer of an Authorisation for Wholesale Medicinal Products for Human Use .docx 71 KB 31/01/2021 View more information
Notification of One-Off (Non-Routine) Import/Export of Tissues and Cells for Human Application .docx 113 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 83 KB 13/11/2020 View more information
Application for an Export Certificate .docx 116 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
Medical Device Incident User Report Form .docx 105 KB 22/01/2020 View more information
Request for Classification of a Borderline Product for Animal Use .docx 70 KB 12/01/2020 View more information
Batch-Specific Requests for Veterinary Medicines .docx 104 KB 07/01/2020 View more information
Application Form A for Transfer of an Authorised (Parallel) or DPR Product .docx 107 KB 17/12/2019 View more information
Application Form B for Transfer before Authorisation .docx 103 KB 17/12/2019 View more information
Annual statistics on stocks of scheduled substances .xlsx 113 KB 16/12/2019 View more information
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