Explanation:
Definitions

Investigational Medicinal Product: a pharmaceutical form of an active substance or placebo being tested, or to be tested, or used, or to be used, as a reference in a clinical trial, and includes a medicinal product which has a marketing authorization but is, for the purposes of the trial -

(a) used or assembled (formulated or packaged) in a way different from the form of the product authorised under the authorization,

(b) used for an indication not included in the summary of product characteristics under the authorization for that product, or

(c) used to gain further information about the form of that product as authorised under the authorization;



Non-Investigational Medicinal Product

Products which are not IMPs as defined above may be supplied to subjects participating in a trial and used in accordance with the protocol.

For instance, some clinical trial protocols require the use of medicinal products such as concomitant or rescue/escape medication for preventive, diagnostic or therapeutic reasons and/or to ensure that adequate medical care is provided for the subject. They may also be used in accordance with the protocol to induce a physiological response.

These medicinal products do not fall within the definition of investigational medicinal products and can be referred to as “non-investigational medicinal products” (NIMPs).




David Hollywood
Argentina
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PRO pts in category: 4