Complete this questionnaire prior to submitting your GMP clearance application and upload it as part of your evidence package on your TGA ebusiness services portal under 'Other' in the evidence tab where:
the evidence for a new manufacturing site has either expired, that is more than three (3) years have passed since the last inspection and no more acceptable recent evidence covering the required scope is available, or
a renewal application is to be submitted and no more acceptable recent inspection has been undertaken of the manufacturing facility.
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.