Make a submission – medicines for human use

Report of side effect (adverse reaction) from medicine for human use DOCX : 112 KB | 28/01/2025 Report of side effect (adverse reaction) for COVID-19 vaccines DOCX : 81 KB | 28/01/2025 Fee application form for human products XLSX : 84 KB | 02/01/2025 Application for a wholesale distribution authorisation DOCX : 116 KB | 23/10/2024 Application form A for transfer of an authorised (parallel) or DPR product DOCX : 68 KB | 16/10/2024 Application for transfer of an authorisation for manufacturing medicinal products for human use DOCX : 107 KB | 19/03/2024 Application for transfer of an authorisation for wholesale medicinal products for human use DOCX : 71 KB | 19/03/2024 Application for transfer of an authorisation for manufacturing investigational medicinal products DOCX : 70 KB | 19/03/2024 IMP immediate notification of variations to Annex 3 and or 4 application form DOCX : 94 KB | 14/03/2024 Application for variation to a manufacturer's authorisation DOCX : 127 KB | 14/03/2024 IMP expedited assessment of variations to Annex 3 and or 4 application form DOCX : 97 KB | 14/03/2024 Annual compliance assessment report for general sale wholesale distributors DOCX : 70 KB | 19/12/2023 Notification of medicinal product shortage from marketing authorisation holder DOCX : 85 KB | 26/10/2023 Request for national scientific and regulatory advice DOCX : 107 KB | 19/09/2023 Application for an export certificate DOCX : 115 KB | 06/09/2023 Application for Addition of a Source Country to a Parallel Import Licence DOCX : 80 KB | 11/07/2023 Application for Dual Pack Import Registration DOCX : 82 KB | 11/07/2023 Application for a Parallel Import Licence - Human Medicines DOCX : 73 KB | 11/07/2023 Quality defect reporting form for MAHs, manufacturers and wholesalers DOCX : 77 KB | 05/07/2023 Batch-specific requests DOCX : 108 KB | 28/05/2023