GMS Australia extemporaneously compounds SPECT & PET Radiopharmaceuticals made to order by customers for particular persons.
Unit dose is a complete solution to your radiopharmaceutical needs.
Individual doses are prepared, quality-assured and packaged for each scan.
Doses are delivered on time to departments for administration to patients.
The unit dose service includes the retrieval, decay and disposal of all radioactive waste from delivered doses.
Unit dose also includes free use of GMS's Secure Insert system; a safe reliable method for handling and disposal of radioactive sharps.
Save time and money.
Terms and Conditions
Supply mechanisms for FDG follow a standard product supply agreement, whereas other products are supplied under a Clinical Trial /Contract Manufacturing Agreement(s) or utilising the TGA Special Access Scheme or Authorised Prescriber rules.
None of the products being available for supply to the general public, and are only available to hospitals, doctors and certain other authorised persons.
All SPECT/PET tracers other than FDG are currently considered by TGA to be unapproved medicines.
All compounded products by GMS Australia are manufactured to GMP standards in a TGA-licenced manufacturing facility. Where a Pharmacopeia Monograph exists, GMS Australia manufactures to that specification.
All Clinical Trials must have ethics approval in keeping with NHMRC guidelines, with an appropriate Clinical Trials Notification (CTN) lodged with TGA.
- SAS A, B and 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
- GMS Australia must be supplied with copies of the CTNs or appropriate SAS forms
- GMS Australia 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, GMS Australia and imaging sites need to have a Supply Agreement in place. We can also provide you with more detailed information on the regulatory requirements mentioned above.