You can request to vary details of the manufacturing licence such as the licence nominees (Persons in control of Quality Control and Production) and manufacturing authorisations (e.g. dosage forms and manufacturing steps etc.)
More information
- Manufacturing medicines
- Suspending, revoking and TGA initiated variation of conditions of a manufacturing licence
- Transfer of a manufacturing licence
- Requesting variations to your manufacturing licence
Clearance
- GMP clearance guidance
- Sponsor responsibilities related to GMP clearance and certification
- GMP Clearance questionnaire
- GMP Clearance code tables guidance
- Notices about GMP clearance
- GMP Clearance code tables guidance - Manufacturing steps
- GMP Clearances: Timeframes for transfers and name change applications
- Clearance Application Assistance Tool
- GMP clearance Sponsor Information Dashboard (SID)
- GMP clearance application and submission user guide
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