Text version of OTC application placement flowchart
This text representation of this flowchart is provided as a list with numbered steps.
Applicant* arranges pre-submission meeting with TGA staff (optional)
Applicant* submits eBusiness application and pays application fee
TGA writes to Applicant providing Submission ID and requests supporting documentation to allow determination of the level of assessment needed
Applicant provides requested supporting information
TGA determines level of assessment needed and invoices assessment fees
Applicant pays assessment fees
TGA conducts assessments, including an onsite quality system audit, if appropriate
If requirements are met, TGA issues Conformity Assessment Certificate
Ongoing TGA surveillance activities/audits
Recertification prior to expiry of certificate
*Applicant may be a manufacturer or their agent or representative.
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.