Regulation 26

the name of the person to whom the CTGT product is to be administered;

where the CTGT product is supplied or dispensed —

at a licensed retail pharmacy — the name, address and any identification number or logo of the licensed retail pharmacy;

at any approved permanent premises by a healthcare service licensee under a business name — the business name, address of the approved permanent premises and any identification number or logo of the healthcare service licensee;

at any temporary premises or approved conveyance by a healthcare service licensee under a business name —

if the healthcare service licensee is also approved under the Healthcare Services Act 2020 to provide the licensable healthcare service at any permanent premises under that business name — the business name, address of the approved permanent premises and any identification number or logo of the healthcare service licensee; or

in any other case — the business name, address and any identification number or logo of the healthcare service licensee; or

by a healthcare service licensee using a remote service kiosk or by delivery under a business name —

if the healthcare service licensee is also approved under the Healthcare Services Act 2020 to provide the licensable healthcare service at any permanent premises under that business name — the business name, address of the approved permanent premises and any identification number or logo of the healthcare service licensee; or

in any other case — the business name, address and any identification number or logo of the healthcare service licensee;

the date that the CTGT product is dispensed;

the directions for the use of the CTGT product;

the name of the CTGT product, being either the proprietary name or the appropriate non‑proprietary name;

the qualitative and quantitative description of any active substance in the CTGT product;

the conditions under which the CTGT product is to be stored;

the appropriate control number, such as a serial number, batch number or lot number;

the expiry date of the CTGT product in day (if applicable), month and year format that is stated in a manner that avoids any confusion as to which is the day (if applicable), which is the month and which is the year;

in relation to an autologous CTGT product, the unique patient identifier and the words “for autologous use only” or similar wordings;

the list of excipients, including preservative systems, for the CTGT product;

any warning that is necessary for the CTGT product;

any precaution relating to the disposal of any unused CTGT product or any waste derived from the CTGT product (where appropriate) and any available collection system for the unused CTGT product or waste.

where the qualified practitioner giving the prescription does not specify that the prescription is to be repeated, the relevant person dispensing the CTGT product must —

when dispensing, mark the prescription in a manner so as to permanently attach the person’s name and address and the dispensing date to the prescription; and

retain the prescription for a period of at least 2 years after dispensing the CTGT product;

where the qualified practitioner giving the prescription specifies that the prescription may be repeated, the relevant person dispensing the CTGT product —

must not dispense more than the total number of times specified on the prescription;

when dispensing, must mark the prescription in such a manner as to permanently attach the person’s name and address and the dispensing date to the prescription; and

must retain the prescription for a period of at least 2 years after dispensing the CTGT product for the last time.