You are here Home Resources and guidance Resources User guide Australian manufacturing licences and overseas GMP certification Australian manufacturing licences and overseas GMP certification: Version history A step-by-step guide Last updated 1 December 2021 Listen Print Share LinkedIn (Twitter) Facebook Email Loading... VersionDescription of changeAuthorEffective dateV1.0Guidance on licensing/certification inspectionsOffice of Manufacturing Quality29/4/2013V2.0Change in titleReduction in scope (no longer applies to medical device manufacturers)Rephrasing of contentPublication following consultation with industry in January 2017Manufacturing Quality Branch and the Regulatory Guidance TeamJuly 2017V2.1Added 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 clearanceMinor editorial changesManufacturing Quality BranchMarch 2019V2.2Minor updates to include remote and hybrid inspections and revised licence issuing processes.Manufacturing Quality BranchDecember 2021 Previous Contacting the Manufacturing Quality Branch