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Manufacturer statutory declarations
11 December 2015
A statutory declaration is a written statement allowing a person to declare something to be true. The declaration is signed in the presence of a witness. Giving false or misleading information as part of a statutory declaration is a criminal offence under the Criminal Code.
The TGA uses statutory declarations whenever certain situations or business operations change to verify information about:
- you
- your managers
- your company.
This is to ensure the TGA is aware of the changes so that your company's licensing requirements remain unbreached and continue in force.
Situations requiring statutory declarations
| Situation | Yes/No | Comment |
|---|---|---|
| I am applying for the TGA to inspect an overseas manufacturer. Does the TGA require a statutory declaration from that manufacturer? | No |
not legally required - your choice |
| I am applying for a variation to my current Manufacturing licence/conformity assessment certificate | No | provided all relevant TGA requirements continue to be met |
| Original management team remains in place but name of licence/conformity assessment certificate holder changes (i.e. company changes name). | No | provided all relevant TGA requirements continue to be met |
| New CEO/Director appointed | No | provided all relevant TGA requirements continue to be met |
| New production or quality manager is to commence | No | provided all relevant TGA requirements continue to be met |
| Situation | Yes/No | Comment |
|---|---|---|
| I am applying for a new TGA licence to manufacture medicines | Yes | Certificate 38(1)(g) |
| Licence changes hands - company is sold to new owner | Yes | Certificate 40(6) |
| I am applying for a secondary site licence on my current Manufacturing licence | No | Provided all relevant TGA requirements continue to be met |
| An individual in my company described in Section 38(1)(g)-(h) of the Act does not meet its requirements. Manufacturing licence is current. | Yes | Certificate 40(6) |
| Situation | Yes/No | Comment |
|---|---|---|
| Conformity Assessment Certificate changes hands - company is sold to new owner | Yes | Certificate 41JA(1C) |
| An individual in my company described in Section 41EB(1) of the Act does not meet its requirements. Conformity Assessment Certificate is current. | Yes |
Clearly mark 'unable to certify' option. Enclose explanatory letter to TGA if desired |
| I am applying (from within Australia) for a new Conformity Assessment Certificate | Yes | Certificate 41EC(3)(a) |
| I am an overseas company applying for a Conformity Assessment Certificate from outside Australia | Yes | Certificate 41EC(3)(a) |
Statutory declaration forms
The following documents incorporate guidelines and instructions for completing the statutory declaration. The last page of the document is the actual form.
Please note: you can complete your form on-screen. However the completed signed hard copy of the form must still be submitted to the address on the initial page.
How to access a pdf or Word document
These forms are available in PDF and Microsoft Word formats. The PDF forms can be filled in and saved to your computer using Adobe Reader version 7 or later or any version of Adobe Acrobat Standard or Professional. If you have an earlier version of Adobe Reader you can fill in the form on-screen and print it out but you will not be able to save the completed form.
Certificate 38(1) (g)
Use Certificate 38(1) (g) if you are applying for a new TGA licence to manufacture medicines.
- Certificate for paragraph 38(1) (g) of the Therapeutic Goods Act 1989 (pdf,110kb)
- Certificate for paragraph 38(1) (g) of the Therapeutic Goods Act 1989 (Microsoft Word,137kb)
Certificate S40(6)
- Certificate for subsection 40(6) of the Therapeutic Goods Act 1989 (pdf,108kb)
- Certificate for subsection 40(6) of the Therapeutic Goods Act 1989 (Microsoft Word,135kb)
Certificate S41EC(3) (a)
- Certificate for paragraph 41EC(3) (a) of the Therapeutic Goods Act 1989 (pdf,102kb)
- Certificate for paragraph 41EC(3) (a) of the Therapeutic Goods Act 1989 (Microsoft Word,134kb)