Special Access Scheme
These products are only for sale to Medical Practitioners
BIOMICTRA™ is for the restoration of the gut microbiota in the management of gastrointestinal disorders.
Our product is the only TGA approved FMT’s for the treatment of C-Difficile infection in Australia. BIOMICTRA™ is also available to certain patients who require it via the TGA’s Special Access Scheme. Under this pathway it is up to the treating physician to define the indications via the forms below.
Our products are only available for sale to registered Medical Practitioners. The BiomeBank team reviews all orders to make sure they comply with all regulations prior to shipping.
The Special Access Scheme
Category B Special Access Scheme – single patient use
Category B is an application pathway which can be accessed by medical practitioners if the patient does not fit the Category A definition for patients who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months and if the therapeutic good is not authorized under Category C notification pathway.
ORDER INSTRUCTIONS: OTHER INDICATIONS
Wait for TGA to send approval letter
Send the TGA approval letter to BiomeBank by Email:
There is a SAS online system available for submissions to the TGA by medical practitioners found here:
Once this has been done one of our team will be in touch.
The product requires storage at -80°C and is delivered on dry ice. To store the product onsite you will need access to a -80°C freezer.
The product can be delivered by enema or colonoscopy. The product is supplied with detailed instructions regarding storage and administration. If you have any further questions please call us and we’ll connect you with our Chief Medical Officer.
If the product is damaged in any way upon receipt please contact email@example.com with photos of the product and description of the issue.