Product Supply

• All PET tracers other than FDG are currently considered by TGA to be unapproved medicines.
• All compounded products by Cyclotek are manufactured to GMP standards in a TGA-licenced manufacturing facility. Where a Pharmacopeia Monograph exists, Cyclotek manufactures to that specification.
• All Clinical Trials must have ethics approval in keeping with NH&MRC guidelines, with an appropriate Clinical Trials Notification (CTN) lodged with TGA.
• SAS A, B & C schemes may be used, depending on the tracer and application. See the TGA website for more information.   https://www.tga.gov.au/form/special-access-scheme
• Cyclotek must be supplied with copies of the CTNs or appropriate SAS forms
• Cyclotek provides a regular consolidated report to TGA on the use of unapproved products using the special access scheme, which identifies the sites using such products

In addition to the above, Cyclotek and the imaging site need to have a Supply Agreement in place. This can be in one of several formats, which we would be glad to discuss with you. We can also provide you with more detailed information on the regulatory requirements mentioned aboveN