Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021 · As enacted · Part 5 · Supply Requirements
23. Records of supply of prescribed CTGT products
Feedback & supportA supplier must, in respect of the supply by retail sale of any CTGT product prescribed by a qualified practitioner, keep at the premises where or from which the CTGT product is supplied a record, complying with paragraphs (2) and (3), of every such supply.
The record required under paragraph (1) must contain all the following particulars:
the date of supply;
the name, identity card or other identification document number, and contact details, of the person to whom the CTGT product is supplied;
the name of the CTGT product, being either the proprietary name or the appropriate non‑proprietary name, and the total amount supplied;
if the CTGT product is supplied by a qualified pharmacist or a person acting under the supervision of a qualified pharmacist, or at or from a licensed retail pharmacy, the name and address of the qualified practitioner who signed the prescription.
The record in paragraph (1) must —
be made on the day on which the CTGT product is supplied or, if that is not reasonably practicable, within the next day even if a public holiday; and
be kept for a period of at least 30 years after the expiry date of the CTGT product or any other shorter period that the Authority allows in a particular case.
A supplier must make available for inspection by the Authority at all reasonable times any record made under paragraph (1).
Subregulation 1
A supplier must, in respect of the supply by retail sale of any CTGT product prescribed by a qualified practitioner, keep at the premises where or from which the CTGT product is supplied a record, complying with paragraphs (2) and (3), of every such supply.
Subregulation 2
The record required under paragraph (1) must contain all the following particulars:
the date of supply;
the name, identity card or other identification document number, and contact details, of the person to whom the CTGT product is supplied;
the name of the CTGT product, being either the proprietary name or the appropriate non‑proprietary name, and the total amount supplied;
if the CTGT product is supplied by a qualified pharmacist or a person acting under the supervision of a qualified pharmacist, or at or from a licensed retail pharmacy, the name and address of the qualified practitioner who signed the prescription.
Subregulation 3
The record in paragraph (1) must —
be made on the day on which the CTGT product is supplied or, if that is not reasonably practicable, within the next day even if a public holiday; and
be kept for a period of at least 30 years after the expiry date of the CTGT product or any other shorter period that the Authority allows in a particular case.
Subregulation 4
A supplier must make available for inspection by the Authority at all reasonable times any record made under paragraph (1).