Manufacturing
Information to assist manufacturers understand their regulatory responsibilities, including licensing.
In Australia, the Therapeutic Goods Act 1989 requires, with certain exceptions, that manufacturers of therapeutic goods hold a licence or a conformity assessment certificate.
It is an offence, carrying heavy penalties, to manufacture therapeutic goods for human use without a licence or a conformity assessment certificate unless the manufacturer or goods are exempt from this requirement.
Only Australian manufacturing sites can obtain a manufacturing licence.
Overseas manufacturers can instead obtain GMP certification following a successful on-site inspection by the TGA.
GMP certification applications are required to be submitted by the Australian sponsor or an agent acting on the Australian sponsor's behalf.
Good manufacturing practice
More information
- Good manufacturing practice: an overview
- Australian manufacturing licences and overseas GMP certification
- Manufacture of therapeutic goods
- Manufacturing principles & guidelines
- Manufacturing basics - Medicines and biologicals
- Manufacturer inspections: an overview
- Target timeframes for manufacturing inspections
- Inspection and audit feedback forms
- Webinar: Good Clinical Practice Inspection Program - 12 May
- SME Assist
Latest alerts
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Product Correction: Some K Care Seat Walkers have been supplied without a complete User Manual.
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Weleda Australia Pty Ltd is recalling one batch of Weleda Baby Teething Powder following a complaint that a fragment of glass was found in one bottle of this product.
Latest articles
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GMP Clearance: Backlog reduction strategy commencing 1 July 2025
Temporary risk-based strategies are being introduced to expedite the reduction of the Good Manufacturing Practice (GMP) Clearance Compliance Verification (CV) backlog. -
Updated GMP clearance information
Our Good Manufacturing Practice (GMP) Clearance information resources have been updated with new information for Sponsors -
Nitrosamine impurities acceptable intakes update - April 2025
Updated information for nitrosamine impurities in medicines consistent with recent EMA updated information.
Latest publications
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A meeting statement from the second meeting of the Point-of-care Manufacturing of Medical Devices Steering Committee is now available.
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A meeting statement from the first meeting of the Point-of-care Manufacturing of Medical Devices Steering Committee is now available.
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The guidelines set out the criteria which must be met for any additional manufacturing sites to be included as secondary sites on new or existing manufacturing licences.