Notificatie OOS van een ATMP
Per 22 mei 2018 is de Eudralex Volume 4 Part IV “GMP requirements for Advanced Therapy Medicinal Products” van kracht. Hieronder volgt een toelichting op vragen naar aanleiding van paragraaf 11.5 “Toediening van niet-conforme producten” en de EMA “Q&A on the use of out-of-specification batches of authorised cell/tissue-based advanced therapy medicinal products”.
11.5. Administration of out of specification products
11.53. Exceptionally, the administration of the cells/tissues that are contained in a cell/tissue based ATMP that is out of specification may be necessary for the patient. Where the administration of the product is necessary to avoid an immediate significant hazard to the patient and taking into account the alternative options for the patient and the consequences of not receiving the cells/tissues contained in the product, the supply of the product to the treating physician is justified.
11.54. When the request of the treating physician is received, the manufacturer should provide the treating physician with its evaluation of the risks and notify the physician that the out of specification product is being supplied to the physician at his/her request. The confirmation of the treating physician to accept the product should be recorded by the manufacturer. In a clinical trial setting, the manufacturer should immediately notify the sponsor of such events. In turn, the sponsor should inform the relevant competent authority. For marketed products, the marketing authorisation holder and the supervisory authority for the site of the batch release should be informed.