Please note: The Department of Health has taken due care in preparing these materials but we do not guarantee, and assume no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in these materials. It should be noted that this is general information only. If you have any doubts about manufacturing requirements, it is recommended that you contact the Manufacturing Quality Branch or seek independent legal advice.
Disclaimer
This GMP decision tree aims to assist applicants to determine what type of GMP application may be required. If you require assistance navigating the tool or understanding your outcome, you may wish to contact the Manufacturing Quality Branch or consider engaging a regulatory affairs consultant.
The Department of Health has taken due care in preparing these materials but we do not guarantee, and assume no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in these materials. It should be noted that this is general information only. If you have any doubts about manufacturing requirements, it is recommended that you contact the Manufacturing Quality Branch or seek independent legal advice.
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Place of manufacture
There are different requirements for manufacturers located in Australia or overseas.
If your manufacturing site is in Australia, you may require a manufacturing licence from the TGA.
Overseas manufacturers can 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. GMP certification is usually only requested if it is not possible to obtain GMP clearance via the Mutual Recognition Agreement (MRA) or Compliance Verification (CV) pathways.
Is the manufacturing site located in Australia or overseas?
Overseas manufacturing site - Type of product
A TGA GMP Certification is not required for products which are not therapeutic goods.
How to determine if your product is a therapeutic good
Therapeutic goods are defined in the Therapeutic Goods Act 1989.
If you are still unsure, you may wish to use the 'Is my product a therapeutic good?' decision tool to help you determine whether the product you are manufacturing is a therapeutic good.
Is the product a therapeutic good as defined in the Therapeutic Goods Act?
Overseas - Not a therapeutic good
A TGA GMP Certification is not required for products which are not therapeutic goods. We recommend you seek independent legal advice to ensure you comply with the legislation.
The following links will direct you to more information on:
Overseas - Therapeutic Good - Medical devices
How to determine if you are manufacturing a medical device
Medical devices are defined in the Therapeutic Goods Act 1989.
There are different requirements for manufacturers of medical devices. The TGA regulates medical devices under Chapter 4 of the Therapeutic Goods Act 1989 and all medical devices must comply with the Essential Principles. For more information, see the Manufacturing medical devices: where to start webpage.
If you are still unsure whether your product is a medical device, you may wish to use the 'Is my product a therapeutic good?' decision tool to assist you in determining what type of therapeutic good you are manufacturing.
Is the product a medical device as defined in the Therapeutic Goods Act 1989?
Overseas - Manufacturer of medical devices
A TGA GMP Certification is not applicable for medical device products.
For more information on manufacturing medical devices, you should visit the Manufacturing medical devices: where to start webpage of the TGA website.
Overseas - Not a medical device
It is an offence to manufacture therapeutic goods for human use without a licence unless the product or manufacturer is exempt from this requirement under the Therapeutic Goods Regulations 1990. For overseas manufacturers, the same exemptions apply unless otherwise specified.
Some therapeutic goods are exempt from licensing requirements. Check Schedule 7 of the Therapeutic Goods Regulations 1990 to find out if your therapeutic good is exempt from the manufacturing principles.
Some persons are exempt from licensing requirements. Check Schedule 8 of the Therapeutic Goods Regulations 1990 to find out if the person manufacturing the goods is exempt from the manufacturing principles.
We recommend you seek independent legal advice to ensure you comply with the legislation.
Is the product or manufacturer exempt under the Therapeutic Goods Regulations 1990?
Overseas - Product or manufacturer is exempt
A TGA GMP Certification is not required for products or manufacturers which would be considered to be exempt from licensing requirements in Australia, under the Therapeutic Goods Regulations 1990.
We recommend you seek independent legal advice to ensure you comply with the legislation.
Overseas - Not exempt
Certain manufacturing steps require GMP clearance in order for a product to be registered or listed on the Australian Register of Therapeutic Goods (ARTG).
Note: GMP certification or clearance is not necessarily required unless the manufacturing step is recorded on the ARTG. If you are unsure whether GMP certification or clearance is required, please contact the TGA before submitting your application.
Is GMP clearance required in order to register or list your product on the ARTG?
Overseas - GMP clearance not required - GMP Certification not required
Based on the selections you have made, a TGA GMP certification would not be required.
Overview
GMP certification or GMP clearance is not necessarily required unless the manufacturing step is recorded on the Australian Register of Therapeutic Goods (ARTG).
If you are unsure whether the manufacturing step is required to be recorded on the ARTG, contact the TGA before you submit your application.
Further information about evidence of GMP compliance for prescription medicines can be found on the GMP clearance for prescription medicines webpage.
Overseas - MRA/CV evidence
If you have suitable evidence available, you may be able to apply for GMP clearance through the MRA and CV pathways rather than obtaining TGA GMP Certification.
Specific information on the MRA and CV pathways can be found on the GMP approach to overseas manufacturers page of the TGA website.
MRA and CV evidence requirements
The TGA has entered into various international agreements and arrangements with other regulators to support international regulatory collaboration. Some of these allow us to use inspections conducted by these regulators for GMP clearance purposes, in lieu of conducting our own on-site inspections.
The MRA and CV pathways to GMP clearance are only available if the relevant overseas regulator has recently inspected the manufacturing site to a GMP standard equivalent to the TGA's for the type of therapeutic good produced there.
It is often not possible to obtain GMP clearance using evidence from another regulator because of differences in the regulatory frameworks and GMP standards for:
- listed medicines including sunscreens
- biologicals, blood and blood components and haematopoietic progenitor cells
If you are unsure whether you have suitable evidence to apply for a GMP clearance through the MRA or CV pathways, please contact the Manufacturing Quality Branch.
Do you have suitable evidence available to obtain a GMP Clearance via the MRA or CV pathway?
Overseas - GMP Certification is required
Based on the selections you have made, TGA GMP Certification is required.
Useful links
The following links provide further information about TGA GMP Certification and how to obtain the certification:
Submit a GMP Clearance application
Based on the selections you have made, a TGA GMP Certification is not required and you should submit a GMP Clearance application.
Useful links
The following links may be useful in helping you submit your GMP Clearance application:
Australia - Type of product
A TGA manufacturing licence is not required for products which are not therapeutic goods.
How to determine if your product is a therapeutic good
Therapeutic goods are defined in the Therapeutic Goods Act 1989.
If you are still unsure, you may wish to use the 'Is my product a therapeutic good?' decision tool to help you determine whether the product you are manufacturing is a therapeutic good.
Is the product a therapeutic good as defined in the Therapeutic Goods Act 1989?
Not a therapeutic good
A TGA GMP manufacturing Licence is not required for products which are not therapeutic goods. We recommend you seek independent legal advice to ensure you comply with the legislation.
The following links will direct you to more information on:
Located in Australia - Therapeutic good - Medical devices
How to determine if you are manufacturing a medical device
Medical devices are defined in the Therapeutic Goods Act 1989.
There are different requirements for manufacturers of medical devices. The TGA regulates medical devices under Chapter 4 of the Therapeutic Goods Act 1989 and all medical devices must comply with the Essential Principles. For more information, visit the Manufacturing medical devices: where to start webpage.
If you are still unsure whether your product is a medical device, you may wish to use the 'Is my product a therapeutic good?' decision tool to assist you in determining what type of therapeutic good you are manufacturing.
Is the product a medical device as defined in the Therapeutic Goods Act 1989?
Australia - Manufacturer of medical devices
A TGA licence is not applicable for medical device products.
For more information on manufacturing medical device products, you should visit the Manufacturing medical devices: where to start webpage on the TGA website.
Australia - Not a medical device
It is an offence to manufacture therapeutic goods for human use without a licence unless the product or manufacturer is exempt from this requirement under the Therapeutic Goods Regulations 1990.
Some therapeutic goods are exempt from licensing requirements. Check Schedule 7 of the Therapeutic Goods Regulations 1990 to find out if your therapeutic good is exempt from the manufacturing principles.
Some persons are exempt from licensing requirements. Check Schedule 8 of the Therapeutic Goods Regulations 1990 to find out if the person manufacturing the goods is exempt from the manufacturing principles.
We recommend you seek independent legal advice to ensure you comply with the legislation.
Is the product or manufacturer exempt under the Therapeutic Goods Regulations 1990?
Australia - Exempt - TGA licence not required
A TGA manufacturing licence is not required for products or manufacturers which are exempt under the Therapeutic Goods Regulations 1990.
We recommend you seek independent legal advice to ensure you comply with the legislation.
Australia - Not exempt - Step of manufacture
'Manufacture' is defined in Chapter 3 of the Therapeutic Goods Act 1989.
Australia - Not a step of manufacture - Licence not required
A TGA manufacturing licence is not required for operations which are not considered to be a step of manufacture as defined in Chapter 3 of the Therapeutic Goods Act 1989.
We recommend you seek independent legal advice to ensure you comply with the legislation.
Australia - TGA GMP Licence required
Based on the selections you have made, a TGA GMP Licence is required.
All Australian sites participating in the manufacture of therapeutic goods, excluding medical devices, unless exempt, must have a licence to manufacture therapeutic goods issued by the TGA that permits the manufacturing steps and dosage forms relevant to the goods being supplied.
Useful links
The following webpages provide further information about the TGA manufacturing licence and how to obtain the licence: