You are here Home How we regulate Manufacturing Manufacture a medicine Good manufacturing practice (GMP) Overseas manufacturers Sponsors can apply for Good Manufacturing Practice (GMP) clearance or certification for their overseas manufacturers. Last updated 8 December 2022 Listen Print Share LinkedIn Twitter Facebook Email Loading... Only Australian manufacturing sites can obtain a manufacturing licence. Overseas manufacturers can instead obtain Good Manufacturing Practice (GMP) clearance or certification. For details go to Sponsor responsibilities related to GMP clearance and certification. More information GMP clearance guidance International agreements and arrangements for GMP clearance GMP Clearance applications using Health Canada evidence Australian manufacturing licences and overseas GMP certification: a step by step guide Declaration of intent to supply the Australian market Access Statement on Good Manufacturing Practice (GMP) Inspections Reliance and Recognition COVID-19 GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic TGA expectations for overseas manufacturing sites hosting remote inspections during the COVID-19 pandemic Topics Manufacturing Medicines Main navigation