Make a submission – medicines for human use

Manufacturing summary sheet form

DOCX : 71 KB | 11/08/2025

Report of side effect (adverse reaction) for COVID-19 vaccines

DOCX : 82 KB | 20/05/2025

Application for register for exemption

DOCX : 68 KB | 19/05/2025

Briefing document for national scientific and regulatory advice

DOCX : 64 KB | 24/02/2025

Request for national scientific and regulatory advice

DOCX : 73 KB | 24/02/2025

Report of side effect (adverse reaction) from medicine for human use

DOCX : 112 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

IMP expedited assessment of variations to Annex 3 and or 4 application form

DOCX : 97 KB | 14/03/2024

Application for variation to a manufacturer's authorisation

DOCX : 127 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

Application for an export certificate

DOCX : 115 KB | 06/09/2023

Application for a Parallel Import Licence - Human Medicines

DOCX : 73 KB | 11/07/2023

Application for Dual Pack Import Registration

DOCX : 82 KB | 11/07/2023