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.
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Manufacturing basics: medicines and biologicals
Links to information on good manufacturing practice (GMP), manufacturing inspections and manufacturer statutory declarations. -
Manufacture of therapeutic goods
Manufacture of therapeutic goods is defined differently depending on the type of therapeutic goods. -
Manufacturer inspections: an overview
Manufacturers of therapeutic goods are regularly inspected by the TGA using a risk-based approach to ensure compliance with GMP standards. -
Make a statutory declaration
Information on when statutory declarations are required by the Therapeutic Goods Administration (TGA).
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Declaration of intent to supply the Australian market
This information is for Australian sponsors or agents of Australian sponsors of overseas manufacturers making GMP certification applications. -
Suspending, revoking and TGA initiated variation of conditions of a manufacturing licence
As part of the revised GMP fees and charges, this information has been updated to reflect changes in TBS. -
Data Management and Data Integrity (DMDI)
Clarification regarding the TGA's position regarding DMDI practices for industry. -
Notices for manufacturers
These notices are for manufacturers of medicines, biologicals and blood, blood components and HPCs.
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Manufacture a medical device
Regulatory responsibilities and expectations for manufacturers of medical devices, including in vitro diagnostics (IVDs). -
Manufacturing biologicals, blood and tissues and advanced therapies
Information on manufacturing biologicals, blood and tissues and advanced therapies. -
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List of licensed manufacturers in Australia
This page explains how to search for Australian manufacturers licensed to manufacture medicines, blood and biologicals, and where to find details of licensing decisions made by us in relation to Australian manufacturers.
Good manufacturing practice
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Good manufacturing practice: an overview
Good Manufacturing Practice (GMP) describes a set of principles and procedures that when followed helps ensure that therapeutic goods are of high quality. -
GMP clearance Sponsor Information Dashboard (SID)
Information about current processing times, workload, priorities, and key messages for GMP Clearance applications. -
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How to obtain GMP clearance through inspection reliance
Find out about obtaining Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site.
Latest alerts
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Product Alert: Australasian Medical & Scientific Ltd (AMSL), the sponsor of the t:slim X2 insulin pump, has identified that certain versions of the device have a wiring problem with the speaker.
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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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New TGA guidance clarifies requirements for compounded medicines
We have published new guidance on Manufacturing, supplying and advertising compounded medicines lawfully, to support compliance with Australia’s regulatory requirements. -
Enforceable direction: Veganic SKN Limited
The delegate believes, on reasonable grounds, that it is in the interests of public health or safety to give Veganic SKN Limited directions under section 42YT of the Therapeutic Goods Act 1989. -
Improving the regulation of sunscreens in Australia
We have opened an 8-week public consultation seeking improvements to the regulation of sunscreens in Australia.
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.
Open consultations
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Consultation: Improvements to the regulation of sunscreens in Australia
We are seeking feedback on proposed changes to improve the regulation of therapeutic sunscreens in Australia.