MHRA produced FAQs for Investigational Medicinal Product (IMP)

[MHRA Super Moderator]

13. Where can I find guidance on the manufacturing requirements for non-investigational products (NIMPs)?

Non-investigational products (NIMPs) are products which are not the object of the investigation, but supplied to a subject in a trial and used as per protocol eg support or rescue/escape medication or preventative, diagnostic or therapeutic treatment to ensure adequate medical care for subjects.

Sponsors must ensure NIMPs are of suitable quality for human use. Guidance on NIMPs is included in Volume 10 Clinical Trials Notice to applicants. Supply of NIMPs with an MA in the Member State or other EU Member State is recommended. However, if they are not licensed in the UK they may be considered to be ?Specials? and appropriate approvals / licenses obtained.

Additional guidance relating to NIMPs is available as follows:
In Chapter III of Volume 10 (external link)
On the MHRA website