For new manufacturing licences, provide us with a statutory declaration on Certificate 38(1)(g). This declaration relates to specific convictions and financial penalties in the 10 years prior to your application. For details, see section 38(1)(g) and 38(1)(h) of the Therapeutic Goods Act 1989. Include the manufacturing licence application tracking number on the declaration form
If you are unable to certify that the persons mentioned in the certificate meet the criteria, you can ask us to consider any special circumstances before we make a decision
The declaration should be submitted with your licence application to make it a valid application.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.