What is an Nimp?

Non-Investigational Medicinal Product (NIMP)* A medical product not defined within the description of an IMP and maybe considered a background (SOC), challenge, concomitant, endpoint or rescue medication (escape) dosed for preventive, diagnosis or therapeutic reasons.

What are non investigational medicinal products?

A Non Investigational Medicinal Product (NIMP) is a medicinal product which is not classed as an IMP in a trial, but may be taken by subjects during the trial.

What are auxiliary medicinal products?

The following definitions are included in the Regulation: Auxiliary medicinal products: A medicinal product used for the needs of a clinical trial as described in the protocol, but not as an investigational medicinal product.

What is IMP treatment?

Regulation (EU) No 536/2014 Article 2 (5) defines an IMP as “a medicinal. 48. product which is being tested or used as a reference, including as a placebo, in a. 49. clinical trial”.

When to use NIMPs in a clinical trial?

Very Little! NIMPs will becomeAuxiliary Medicinal Products (AMPs) Definition: Medicinal product used for the needs of the clinical trial as described in the protocol but not as an Investigational Medicinal Product. • Authorised – in any member state • (unauthorised) – can be used in ‘justified cases’ (para 53) • Be certain it’s a AMP!

What is a non investigational medicinal product ( NIMP )?

—Defines nIMPs, provides examples, and required filing documentation Non-Investigational Medicinal Product (NIMP) A medical product not defined within the description of an IMP and maybe considered a background (SOC), challenge, concomitant, endpoint or rescue medication (escape) dosed for preventive, diagnosis or therapeutic reasons.

When do NIMPs will becomeauxiliary medicinal products ( amps )?

NIMPs will becomeAuxiliary Medicinal Products (AMPs) Definition: Medicinal product used for the needs of the clinical trial as described in the protocol but not as an Investigational Medicinal Product. • Authorised – in any member state • (unauthorised) – can be used in ‘justified cases’ (para 53) • Be certain it’s a AMP!

Can a NIMP be used as an imp in the EU?

In exceptional circumstances a NIMP without a MA in the EU may need to be used. Although these products do not fall within the definition of the IMP, some Member States may treat them as an IMP for the purposes of applying for a clinical trial authorisation if they are not authorized for the indication in the Member State7. 1.2.