Maintain Traceability System
CTGTP registrants, manufacturers, importers and suppliers are required to establish and maintain a system to ensure traceability of the 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, where relevant:
- Delivery to the hospitals, clinics, nursing homes or retail pharmacies where the CTGTP is used, administered, supplied or disposed
A traceability system is also to be maintained at or from the hospital, clinic, nursing home or retail pharmacy that is supplied with the CTGTP to enable linkage to the patient who received the CTGTP.
Records Retention period
At least 30 years after the expiry date of the CTGTP