Does FMD apply to clinical trials materials?
If an existing licensed drug is used in a clinical trial, when would it need to be decommissioned?
No, the clinical trial supply chain sits outside the scope of the Delegated Regulation.
However, if a pack of medicines within the scope of the Delegated Regulation is to enter the clinical trial supply chain and intended to be used as an investigational medicinal product, it MUST be decommissioned before it leaves the ‘commercial’ supply chain and becomes part of the trial medication stock.