Make a submission – medicines for human use

notification-of-advisory-board-meeting

Notify us when an advisory board meeting is taking place.

Application for a wholesale distribution authorisation

Application form A for transfer of an authorised (parallel) or DPR product

Application for transfer of an authorisation for manufacturing medicinal products for human use

Application for transfer of an authorisation for wholesale medicinal products for human use

Application for transfer of an authorisation for manufacturing investigational medicinal products

IMP immediate notification of variations to Annex 3 and or 4 application form

Application for variation to a manufacturer's authorisation

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

Fee application form for human products

Notification of medicinal product shortage from marketing authorisation holder

Request for national scientific and regulatory advice

Application for an export certificate

Application for Addition of a Source Country to a Parallel Import Licence

Application for Dual Pack Import Registration

Application for a Parallel Import Licence - Human Medicines

Batch-specific requests

Request for pre-submission meeting for MIA