EMA: Updated Q&A on OOS Batches of ATMPs
The EMA has revised its questions and answers on the use of out-of-specification (OOS) batches of authorised cell- and tissue-based ATMPs (“Questions and answers on the use of out-of-specification batches of authorised cell/tissue-based ATMPs”, Rev. 1, 2026). The revision provides clearer guidance on the exceptional circumstances under which an OOS batch may be used. It refers to Section 11.5 of the ATMP GMP guidelines (Part IV of the EU GMP Guide). Use is only possible when it is necessary to avoid an immediate and significant risk to the patient.
At the same time, the document further clarifies the roles of the manufacturer, importer and marketing authorisation holder, as well as the requirements for notification and reporting to authorities and the EMA. It also places greater emphasis on systematic documentation and trend evaluation of OOS cases.
The fundamental principles of the original 2019 version remain unchanged.
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