Planning For The Return And Destruction Of Your Product When Establishing Your Clinical Supply Strategy

Since the transition period for EU regulation 536/2014 started this year, focus has returned to meeting all of the demands that will change from the Directive that everyone has been accustomed to following. One commonly overlooked detail listed in the protocol requirement described in Annex I, states that the clinical protocol shall include “a description of the arrangements for tracing, storing, destroying and returning the investigational medicinal product and unauthorized auxiliary medicinal product . . .” This highlights an aspect of clinical supply management that is typically not a main consideration during the trial planning phase.

Aspects of accountability, reconciliation, return, and destruction should be part of the drug supply planning process. Unfortunately, however, this is often overlooked and significant effort is required to compile historical data. This difficulty can be avoided with a little up-front planning that in itself does not need to be extensive or detailed, but can remove many future complications.

This article shares key considerations and key questions to ask your clinical supplies vendor.