VIDIDENCEL, Australasian Leukaemia & Lymphoma Group (ALLG), CON-1225
Product name
VIDIDENCEL
Sponsor name
Australasian Leukaemia & Lymphoma Group (ALLG)
ARTG
Consent start
Consent no.
CON-1225
Standard
s9(4), 9(5), 9(7), 9(8), 9(9), 9(10), 10(1), 10(2), 10(7), 10(8), 10(9), 11(1), 11(2), 11(3), 11(4), 11(7), 11(8), 11(9), 11(15), 11(16), 11(18), 11(19), 12(1) and 12(2) 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 requirements regarding collection and
screening of donor social and medical history, and infectious disease testing
results.
Conditions imposed
1. This consent to import and supply VIDIDENCEL is limited to the HREC-approved
clinical trial protocol associated with the Clinical Trial Notification provided
to the Therapeutic Goods Administration.
2. If the Sponsor obtains any additional information regarding the social and
medical history or infectious disease testing results of the donor of the
biological starting material for VIDIDENCEL, that they inform the Therapeutic
Goods Administration of any new evidence that substantively alters the estimated
risks, and that this information is provided to the Therapeutic Goods
Administration for review.
Therapeutic product type
Other therapeutic goods non-approved