Four questions and their answers clarify
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:
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:
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).
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