Good Manufacturing Practice (GMP) pre-submission meeting form

This form is for applicants of medicines and biologicals to request for a GMP pre-submission meeting.

Download form

Before completing your form

Ensure you:

• have reviewed the information on GMP pre-submission meetings.

Submitting your form

Email the completed form to the relevant contacts based on your query and GMP application types:

• For GMP licensing (LI) and certification (CE) applications: GMP@health.gov.au
• For GMP clearance (CL) applications: GMPClearance@health.gov.au

Incomplete or inaccurate information may result in delays or requests for further information.