You must comply with regulatory requirements when manufacturing prescription medicines.
Prescription medicines must be manufactured in accordance with legislated Good Manufacturing Practice (GMP). These standards ensure their quality, safety and efficacy.
You are responsible for maintaining quality during production, supply, transport, and distribution.
We regulate manufacturing to protect public health and ensure prescription medicines remain safe and effective.
If you import or export prescription medicines, you must comply with Australian laws.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to prescription medicines. You may also have to meet obligations that apply to all medicines and all products.
Good Manufacturing Practice
Understand the standards for Good Manufacturing Practice.
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GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
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PageComplying with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to Good Manufacturing Practice (GMP).
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PageInformation for sponsors and applicants preparing applications and requests involving steps in the manufacture of medicines regulated as prescription medicines.
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PageThis guidance is for both licenced manufacturers and community pharmacists involved in the manufacture of compounded medicines or dose administration aids.
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PageInformation on complying with good manufacturing practice (GMP).
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GuidanceThis guidance explains good manufacturing practice (GMP) requirements for Australian sponsors and manufacturers of medicines, active pharmaceutical ingredients (APIs) and sunscreens.
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PageRegulatory responsibilities and expectations for medicine manufacturers.
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PageLinks to information on good manufacturing practice (GMP), manufacturing inspections and manufacturer statutory declarations.
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PageUnderstand your record keeping responsibilities.
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GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
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GuidanceGuidance on good manufacturing practice (GMP) compliance requirements for domestic and overseas manufacturers of medicines and biologicals.
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PageSponsors have ongoing responsibilities when a prescription medicine is registered in the Australian Register of Therapeutic Goods (ARTG).
GMP clearance
Access information on applying for GMP clearance.
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Decision treeUse the GMP Clearance Application Assistance Tool (CAAT) to assist in determining the general evidence requirements for your GMP clearance applications.
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PageSearch the Code Tables for codes needed to apply for good manufacturing practice (GMP) clearance.
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User guideThis user guide is for sponsors wanting to submit GMP clearance application by the TGA Business services (TBS) portal.
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User guideCheck out our user guide to assist sponsors when using the code tables for GMP Clearance applications.
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PageInformation about current processing times, workload, priorities, and key messages for GMP Clearance applications.
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PageFind out about obtaining Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site.
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PageInternational agreements and arrangements for GMP clearance
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PageSponsors can apply for Good Manufacturing Practice (GMP) clearance or certification for their overseas manufacturers.
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PageThis information explains your responsibilities when obtaining Good Manufacturing Practice (GMP) clearance by any pathway, or by GMP certification following our inspection.
Licensing
Find out how to apply for, vary or maintain a manufacturing licence.
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PageThere is an annual charge for the manufacturing of therapeutic goods.
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PageA step-by-step guide to assist Australian manufacturers of therapeutic goods apply for a Good Manufacturing Practice (GMP) licence.
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User guideA step-by-step guide for Australian manufacturers of therapeutic goods.
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PageA step-by-step guide for Australian manufacturers of therapeutic goods (other than medical devices) applying to vary a manufacturing licence.
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PageRevocation of manufacturing licence due to non-payment.
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PageThis guidance is for Australian manufacturers who wish to transfer a manufacturing licence to another entity.
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PageVary your Good Manufacturing Practice (GMP) clearance or licence.
Certification
Access information on applying for or varying certification.
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User guideA step-by-step guide for Australian manufacturers of therapeutic goods.
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PageThis information is for Australian sponsors or agents of Australian sponsors of overseas manufacturers making GMP certification applications.
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PageThis information explains your responsibilities when obtaining Good Manufacturing Practice (GMP) clearance by any pathway, or by GMP certification following our inspection.
Inspections
Learn how TGA conducts inspections of manufacturing sites.
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PageWhen we inspect a manufacturer for compliance with GMP, we assess your level of compliance with the manufacturing principles and any other requirements (such as TGOs and conditions of authorisation)
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PageWe regularly inspect manufacturers of medicines and biologicals, using a risk-based approach, to ensure compliance with manufacturing principles.
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PageA manufacturer's compliance level is determined by the number and nature of deficiencies found during inspections, and their response to the inspection report.
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PageManufacturers of therapeutic goods are regularly inspected by the TGA using a risk-based approach to ensure compliance with GMP standards.
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PageAll timeframes are variable depending on the cooperation of manufacturers, sponsors and sometimes international regulatory agencies
Product types