Regulation 34

Every manufacturer, importer, supplier or registrant of a CTGT product must establish and maintain a system of traceability that complies with paragraph (2).

The system mentioned in paragraph (1) must at the minimum enable the traceability of the CTGT product and its starting and raw materials, including all substances that may come into contact with the cells or tissue it contains during any of the following processes:

Every supplier must ensure that a system of traceability is in place and maintained at or from the licensed retail pharmacy or the approved permanent premises, temporary premises, approved conveyance or remote service kiosk of a healthcare service licensee to which the supplier supplies a CTGT product, in order that the CTGT product administered or supplied may be linked to the patient who received it, and vice versa.

Every manufacturer, importer, supplier or registrant mentioned in paragraphs (1) and (3) must keep all data obtained from the system of traceability for 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 person who fails to comply with paragraph (1), (2), (3) or (4) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 6 months or to both.

A person who, in compliance or purported compliance with paragraph (1), (2), (3) or (4), provides the Authority or an enforcement officer with any record which the person knows is false or misleading shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.