Six pairs of questions and answers explain a possible pathway for the administration of such out-of-specification (OOS) batches that have already been granted a marketing authorisation. The overall goal is to avoid an immediate significant hazard to the patient:
“The supply of an OOS batch can only occur when the conditions laid down in Section 11.5 of the ATMP-Guidelines are met, in particular that the manufacturer provides an evaluation of the risks to the treating physician and that the supply of the batch is requested by the treating physician after having considered the specific condition of the patient and the evaluation of the risks provided by the manufacturer”, it is stated.
Answers are given, e.g., on the following questions:
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