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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 an authorised witness. Giving false or misleading information as part of a statutory declaration is a criminal offence under the Criminal Code.
The TGA seeks that statutory declarations be provided in certain situations to verify information about:
- you
- your managers
- your company.
Completion of a statutory declaration ensures the TGA has accurate information in relation to your circumstances.
Circumstances where statutory declarations should be provided
| 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 |
| 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 | Commonwealth statutory declaration should be provided to certify matters referred to in paragraph 38(1)(g) of the Therapeutic Goods Act 1989. |
| Licence changes hands - company is sold to new owner | Yes | Commonwealth statutory declaration should be provided to certify matters referred to in paragraph 38(1)(g) of the Therapeutic Goods Act 1989. |
| I am applying for a secondary site licence on my current Manufacturing licence | No | Provided all relevant TGA requirements continue to be met |
| I have a current manufacturing licence however an individual in my company does not meet the requirements described in paragraphs (g)-(h) of section 38(1) of the Therapeutic Goods Act 1989 | Yes | Commonwealth statutory declaration should be provided to certify matters referred to in paragraph 38(1)(g) of the Therapeutic Goods Act 1989. |
Instructions for submitting a Commonwealth statutory declaration are found at Instructions for completing a statutory declaration regarding 38(1)(g).
| 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) |
Certificates
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 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)