I was looking for the information on MHRA website about the requirement for IB/IMPD/SPC for clinical trial. My question is particularly related to off label use or use of drug outside its license (such as paediatric use or different indication). If a drug is used in this way but is used extensively in NHS practice for example over 10 years do you still require IB or IMPD or a SmPC is enough?

Also do we need IB and IMPD both or when is the either required?

Thank you.