Applying for a prescription medicine via the provisional registration pathway

The provisional registration pathway has the same legislative timeframe as our standard pathway for new medicine applications (255 working days). We aim to complete the review as quickly as possible.

Provisional registration is for prescription medicines that treat serious and life-threatening conditions. The medicine must be either:

• new and promising
• existing but with promising new indications.

Eligibility criteria apply.

To allow earlier access to these medicines, we provisionally register them based on preliminary clinical data.

We assess:

• whether the potential benefit outweighs the risk.
• your clinical study plan to collect additional clinical data to support transition to full registration.

Provisional registration is limited to 2 years while you conduct the studies outlined in your clinical study plan.

You can apply for 2 extensions up to a maximum of 6 years.

During this period, you will need to submit your application to transition to full registration.

If you do not transition your provisional registration to full registration within the 6 years, your provisional registration will lapse.

You can only apply for full registration once you have enough clinical data to confirm the medicine's safety and efficacy.