Declaration of intent to supply the Australian market
Version 1.0, August 2017
This information is for Australian sponsors or agents of Australian sponsors of overseas manufacturers making GMP certification applications.
A declaration of intent to supply is only required for GMP certification applications where the manufacturing site:
- is not currently supplying therapeutic goods to Australia
- is not nominated on the Australian Register of Therapeutic Goods (ARTG)
Reason for declaration of intent to supply
The TGA does not automatically accept a GMP certification application as a reason to arrange and conduct an overseas inspection. The TGA is responsible for ensuring that therapeutic goods available for the Australian market are safe and fit for their intended purpose.
Overseas manufacturers are unable to sponsor medicines for supply to the Australian market. Therefore, overseas manufacturers must supply a declaration by an Australian sponsor, in support of a GMP certification application, where required.
This allows us to confirm the intention to use products manufactured overseas in the Australian supply chain, if and when we issue the manufacturer with certification.
We require additional information before inspection arrangements are progressed; where the applicant is a sponsor with no medicine currently on the ARTG, and with no applications for inclusion in the ARTG lodged with the TGA for goods manufactured at the manufacturing site stated in the GMP certification application.
It is important to note that we may not conduct reinspections of manufacturers that have not supplied product to the Australian market. This may result in a lapse of GMP certification.
How to prepare a declaration of intent to supply
The declaration is made on the assumption that the TGA inspection will lead to approval for the overseas manufacturer to enter the Australian supply chain.
There is no formal template for this declaration.
The declaration can be in any legible format, but must:
- be made by one or more current Australian sponsor(s) who intend to use the manufacturer in the Australian supply chain of their sponsored medicines
- be in English and readable
- contain the sponsor's letterhead
- contain the TGA Client ID of the company making the declaration
- contain the inspection application MIS tracking number (where applicable)
- detail the types of therapeutic goods that the manufacturer will be manufacturing for the Australian market
- state the projected date(s) at which the therapeutic goods will be entered in the ARTG
- state the projected dates(s) the supply to the Australian market will commence
- be signed by a senior officer in the company (i.e. the CEO, director or general manager)
Please note, we may request additional information to clarify details given in the declaration.
Include the declaration as part of the GMP certification application or email the declaration to the Manufacturing Quality Branch. Put the application tracking number in the email subject line.
What if I have no sponsor to provide this declaration?
We actively discourage any application for an overseas inspection where an Australian sponsorship network is not already in place. If you, the applicant, have no sponsor in current arrangements, then you will need to identify this in an email to the Manufacturing Quality Branch and show cause why the inspection should be conducted.
|Version||Description of change||Author||Effective date|
|V1.0||Original publication following consultation with industry in January 2017||Manufacturing Quality Branch||August 2017|