Regulation 25

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

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

an 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;

where the CTGT product is registered, the registration number assigned to the registered CTGT product by the Authority;

the conditions under which the CTGT product must be stored;

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;

the name and address of the registrant or the manufacturer, as the case may be.

must be provided in English; and

must be legible and indelible.