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| Version | Description of change | Author | Effective date |
|---|---|---|---|
| V1.0 | Guidance on licensing/certification inspections | Office of Manufacturing Quality | 29/4/2013 |
| V2.0 | Change in title Reduction in scope (no longer applies to medical device manufacturers) Rephrasing of content Publication following consultation with industry in January 2017 | Manufacturing Quality Branch and the Regulatory Guidance Team | July 2017 |
| V2.1 | Added instructions for selecting manufacturer name and site details, and the manufacturing activities in the New Licence application form. Added clarification for application fees and where declining to contribute to cost of an overseas inspection, the impact on obtaining GMP clearance Minor editorial changes | Manufacturing Quality Branch | March 2019 |
| V2.2 | Minor updates to include remote and hybrid inspections and revised licence issuing processes. | Manufacturing Quality Branch | December 2021 |