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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.
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)