The licensing and certification process

Determining the appropriate process

1. Determining whether licensing or certification is required
2. Complying with manufacturing principles

New applications

Preparing your application

3. Becoming a TGA client
4. Compiling documentation

Applying for a licence or GMP certification

5. Making a statutory declaration
6. Drafting and submitting your application
   1. Submitting a TGA manufacturing licence application
   2. Submitting a GMP certification application
7. Paying the application fee
8. Determining your application's effectiveness

Inspections

Preparing for inspection

9. Scheduling the inspection
10. Paying inspection invoices

The inspection

11. Pre-inspection preparation
12. The onsite inspection
13. The post-inspection letter
14. Addressing deficiencies
15. Reviewing your responses and closeout

Finalisation

16. The inspection report
17. Paying your final invoice
18. Providing feedback
19. Making a decision
20. Granting licences and certificates

Ongoing compliance

21. Conducting follow-up inspections
22. Keeping us up to date and making requests