Claire van Leersum
From the GMP Committee
Typically, if Therapy A and B are licensed standard care treatments used as authorised but in combination with the IMP, these are not IMPs and you could possibly use the definition of a background treatment to also justify this. However, as the IMP definition in Volume 10 states, as long as Therapy A and B are used without change to formulation and/or packaging, or are not used for an unauthorised indication, or used to gain further information about the authorised form, then you fine to not define the therapies as IMPs. A marketed product used in a trial is really only considered an IMP if any of the above apply. If it is used completely as it has been authorised then you should be OK.
It follows then that if the therapies were used outside of their authorised indication, they would have to be classed as IMPs.