FW: TGA regulations for faecal microbiota transplant (FMT) products in Australia.

[Glenys Harrington]

Dear all,

Find below the newly released “TGA regulations for faecal microbiota
transplant (FMT) products in Australia”.

“It is anticipated that the new regulatory amendments for FMT products will
be implemented on 1 January 2020 with a transition period of 12 months, i.e.
commencement from 1 January 2021”.

Regards

Glenys

Glenys Harrington

Consultant

Infection Control Consultancy (ICC)

P.O. Box 6385

Melbourne

Australia, 3004

M: +61 404816434

E: infexion@ozemail.com.au

Dear Stakeholder

For your information, we’d like to share our recently published TGA
statement on the regulation of FMT products in Australia:

https://www.tga.gov.au/tga-regulation-faecal-microbiota-transplant-fmt-produ
cts-australia

If you have any further questions about the regulation of FMT products in
Australia, please contact us at this address: bloodandtissues@tga.gov.au

Kind regards

Biological Science Section

Scientific Evaluation Branch

Medicines Regulation Division | Health Products Regulation Group

Australian Government Department of Health

PO Box 100, Woden ACT 2606, Australia

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We pay
our respects to all Elders past and present.

_____

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