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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) |