Overview
This application will enable a discussion with the Medicines Authority about scientific matters regarding the development and licensing of medicinal products.
What you'll get
Scientific advice will be obtained.
Eligibility
Marketing Authorisation Holders and manufacturers.
How to apply
Fill in the online form and submit.
The pages where signatures are required must be printed, signed, and attached to the same online form using the document uploader.
The pages where signatures are required must be printed, signed, and attached to the same online form using the document uploader.
Timeline
Submission of Application
Vetting of Application
14 days
Delivery of Service
3 months
