Licences & authorisations
Apply for a licence or authorisation
Find the application route for the activity you intend to undertake. Each route explains who needs to apply, the evidence required, the assessment process, applicable fees and the responsibilities that continue after authorisation.
Choose a route
Application routes
Select the activity you intend to undertake to see the full guidance and start an application.
Manufacture or assemble medicines Wholesale distribution Import or export medicines Supply an unlicensed medicine Conduct a clinical trial Undertake medicinal-cannabis activities Request an inspection or GMP-related service Amend an existing authorisation Renew an authorisation Surrender an authorisation
What every route explains
How applications work
1
Who needs to apply
Check whether your activity is regulated and which route applies.
2
Evidence required
Prepare the documents, standards and declarations the route asks for.
3
Assessment & fees
Understand the assessment process, timelines and applicable fees.
4
Ongoing responsibilities
Meet the obligations that continue after authorisation is granted.