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Use of OOS batches of authorised cell/tissue-based ATMPs – Section 11.5 of the Guidelines on GMP for ATMPs

  • 27 июня 2019
  • ATMP, authorized, batches, CAT, cell/tissue-based, EMA, GMP, guidelines, implementation, MA, OOS, patient, provision, Q&A, section 11.5, use,

ASE Pharma Solutions

On 25 June 2019 EMA has published document entitled Questions and answers on the use of out-of-specification batches of authorised cell/tissue-based advanced therapy medicinal products prepared by EMA’s CAT, together with the GMDP Inspectors Working Group and the Blood Products Working Party.


This document includes the questions and answers describing the process and responsibilities for using OOS batches of authorised ATMPs in patients (implementation of the provision in section 11.5 of the guidelines on GMP for ATMPs).

Source: EMA

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