MHRA produced FAQs for Investigational Medicinal Product (IMP)

[MHRA Super Moderator]

2. What is an investigational medicinal product (IMP)?

An investigational medicinal product is any medicinal product which is being tested within a trial or any product, including placebo, used as a reference in a clinical trial. This includes products with a marketing authorisation where the product is:

• used in a different form from the marketing authorisation
• used for an indication not included in the summary of product characteristics for that product or
• used to gain further information about the product as authorised in the clinical trial authorisation.