Cardiovascular Tissue - The Sydney Heart Valve Bank, Sydney Heart Valve Bank, CON-1217
Product name
Cardiovascular Tissue - The Sydney Heart Valve Bank
Sponsor name
Sydney Heart Valve Bank
Consent start
Consent no.
CON-1217
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 TGA of
any new evidence that substantively alters the estimated risks, such that they
become unacceptable.
Therapeutic product type
Prescription medicines