Skip to main content

You are here

Investigational Medicinal Product (IMP)

“a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorization but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form”

- IMP definition as taken from Directive 2001/20/EC, Article 2 (d)

It is important to identify clinical trials which fall within the scope of The Clinical Trials Regulations early on in the design stages (and prior to any declaration of sponsorship being made). Clinical Trials of Investigational Medicinal Products (CTIMPs) require authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) and a favourable opinion by an ethics committee. This authorisation is granted in the form of a Clinical Trial Authorisation (CTA). It is a criminal offence to conduct a CTIMP anywhere in the UK without a CTA.

To classify whether the proposed medicinal product to be used in a clinical trial setting falls within the definition of Investigational Medicinal Product (IMP) and therefore within the scope of the Directive 2001/20/EC, the Chief Investigator (ultimately the sponsor when considering a sponsorship request) must consider both the products intended use and the objectives of the study.

Medicinal products which are not the object of investigation (i.e those used as support or rescue medication for preventive, diagnostic or therapeutic reasons) are classified as non-investigational medicinal products (NIMPs).  Studies that involved NIMPs do not fall within the scope the Directive and may be supplied to subjects participating in a trial and used in accordance with the protocol.

Where there is any uncertainty as to whether the proposed use of a medicinal product within a clinical trial falls within the scope of Directive or not, refer to the MHRA algorithm.  If, after using the algorithm there is still uncertainty contact the Noclor Sponsor Representative, who will forward  the protocol on to the MHRA Clinical Trials Helpline for a ‘Protocol Scope – Review’.