Musculoskeletal Tissue - Australian Biotechnologies Pty Limited, Australian Biotechnologies Pty Limited, CON-1214
Product name
Musculoskeletal Tissue - Australian Biotechnologies Pty Limited
Sponsor name
Australian Biotechnologies Pty Limited
Consent start
Consent no.
CON-1214
Standard
Part 2 Section 10 (9) and Schedule 1 Item 8(b) and Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021
Non-compliance with standard
The products will not comply with the requirement of indefinite geographical
deferral for variant Creutzfeldt-Jakob disease (vCJD) risk, applicable to tissue
donors having spent a cumulative length of time of 6 months or more in the UK
between 1980 and 1996 or receiving a transfusion or injection of blood or blood
components while in the UK at any time on or after 1 January 1980.
Conditions imposed
1. That the sponsor continues to monitor the literature and informs the
Therapeutics Goods Administration of any new evidence that substantively alters
the estimated risks, such that they become unacceptable.
2. The s14 approval is only for musculoskeletal tissue collected from donors in
Australia.
Therapeutic product type
Blood, tissues, and biologicals