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​

Step 1 – Download and complete TGA Form

Download:
ACCESS FORM CATEGORY B

Send the completed form to the TGA by email:
SAS@health.gov.au

Step 2 – Wait for TGA Approval

Wait for TGA to send approval letter

 

Step 3 - Complete BiomeBank Order Form

If you would prefer to download the order form it is available here: 
BiomeBank Order form

Please send the completed form to:
orders@biomebank.com

If you have any questions about ordering our product then please email us at:
orders@biomebank.com

Step 4 - Send us the TGA Approval

Send the TGA approval letter to BiomeBank by Email:

orders@biomebank.com

 

There is a SAS online system available for submissions to the TGA by medical practitioners found here:
https://www.tga.gov.au/special-access-scheme-and-authorised-prescriber-online-system

 

Once this has been done one of our team will be in touch.

 

Hospitals FAQ

How do I store the product?

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.

How do I administer the product?

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.

 

What if there is an issue with the product?

If the product is damaged in any way upon receipt please contact safety@biomebank.com with photos of the product and description of the issue.

Still have questions about us or our products?
Get in touch with our team