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Does anyone have experience or advice regarding the labeling of commercially available IMP for use as post-treatment in a clinical trial?
To elaborate: in a study protocol, a commercial product is used for a new indication (as IMP) together with another IMP, and both products are labeled according to Annex 13 and are used by sites in Europe. According to the protocol, patients can be offered the commercial available IMP for free from sponsor for further treatment after study treatment has ended. Since the medicine is expensive and there is still IMP stock at the depot and pharmacy, we would like to use the left overs from the trial. The challenge is that IMP is labeled for the clinical trial, and this cannot be used as post treatment according to the text of the protocol. Updating the protocol is not possible.
Do you have any experience or tips on how we can utilize stock in this context? Can we re-label? In that case, it is enough to make an additional labeling with “For post-treatment use in trial XXXX only”, or similar. Can such additional labeling be done at local pharmacies? Can it be performed at the depot? And what is the requirement when it comes to competent authorities, information/approval etc.?
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