Four questions and their answers clarify

• The responsibilities of the Qualified Person in the event of re-testing
• Which exemptions apply
• Which data are to be submitted
• The responsibilities of the Qualified Person in case of an exemption.

Explanation:

A Qualified Person must ensure that each imported batch of an ATMP is re-tested. However, if there is a Mutual Recognition Agreement (MRA) including ATMPs or a similar arrangement with a third country, the Qualified Person may certify the reliability of the controls carried out there. In exceptional cases, re-testing ATMPs which are imported from third countries without MRAs, is not necessary.
Then the following conditions must be fulfilled in accordance with 11.17 of the EU GMP Guidelines Part IV for ATMPs:

• " limited quantity of available material" or
• "short shelf life" and
• "the examinations in the third country should be carried out in GMP-certified establishments".

According to the EMA, an exemption is only intended for patient-specific ATMPs such as autologous products and companies are required to consult the EMA in time. In addition to the original application for approval, manufacturers must submit the following information:

• total batch size and number of units required for batch release testing;
• available stability data and proposed shelf life;
• analytical sampling plan;
• a GMP certificate issued by an EEA Competent Authority relevant to the particular category of testing at the facility located in the third country

This is the second Q&A document on ATMPs published by the EMA. In June 2019, a Q&A on the use of OOS-batches of authorized ATMPs was published (we reported).

Sources:

EMA: Q&A on the exemption from batch controls carried out on ATMPs imported into the European Union from a third country