Regulation 78B Post authorisation requirements in relation to UKMA(UK)(Category 1) for advanced therapy medicinal productsF1F6

establish and maintain a system ensuring that the individual product and its starting raw materials, including all substances coming into contact with the cells or tissues it may contain, can be traced through the sourcing, manufacturing, packaging, storage, transport and delivery to the hospital, institution or private practice where the product is used;

where the product contains human tissues or cells, ensure that the traceability system is complementary to and compatible with requirements imposed pursuant to—

keep the data referred to in paragraph (a) for a minimum of 30 years after the expiry of the date of the product, or longer if required by the licensing authority as a term of the F3UKMA(UK)(Category 1); and

in the event of the F4UKMA(UK)(Category 1) holder's bankruptcy or liquidation occurring within the period of time for which that holder is required to keep the data referred to in paragraph (a), transfer that data to another person or the licensing authority.