Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021 · As enacted · Part 4 · Ctgt Product Supply — Licensing and Exceptions
17. Duty to obtain consent and provide information for supply of unregistered Class 2 CTGT products in certain circumstances
Feedback & supportA person may only supply an unregistered Class 2 CTGT product under regulation 21 or 22 to a patient if the person obtains consent from the patient for the supply of that CTGT product to that patient in accordance with paragraph (2).
A patient’s consent mentioned in paragraph (1) may be obtained only after the patient has been informed of all of the following:
that the CTGT product to be supplied to the patient is not registered with or approved by the Authority;
that the safety, efficacy and quality of the CTGT product to be supplied to the patient has not been evaluated by the Authority.
Subregulation 1
A person may only supply an unregistered Class 2 CTGT product under regulation 21 or 22 to a patient if the person obtains consent from the patient for the supply of that CTGT product to that patient in accordance with paragraph (2).
Subregulation 2
A patient’s consent mentioned in paragraph (1) may be obtained only after the patient has been informed of all of the following:
that the CTGT product to be supplied to the patient is not registered with or approved by the Authority;
that the safety, efficacy and quality of the CTGT product to be supplied to the patient has not been evaluated by the Authority.