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

All manufacturers
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

Certificate 40(6)

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
Medicines manufacturers
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)
Conformity Assessment Certificate applicants and holders
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

Certificate 41JA(1C)

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 S40(6)

Certificate S41EC(3) (a)

Certificate S41JA(1C)