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.
Is my study a trial of an Investigational Medicinal Product (IMP)?
• The GOV website has an algorithm available to identify if the study is a clinical trial of a medicinal product, this can be accessed here.
• If you need further clarity on this the CNTW R&D Team can advise further by contacting [email protected]
What is a Medical Device?
Medical device’ means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:
diagnosis, prevention, monitoring, treatment or alleviation of disease,
diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
investigation, replacement, modification, or support of the anatomy or of a physiological process,
supporting or sustaining life,
control of conception,
disinfection of medical devices
providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.
Will CNTW Sponsor a CTIMP Study?
CNTW will consider sponsorship for a CTIMP Study. You should make initial contact with the R&D Manager and R&D team via email [email protected] where all requirements are discussed and the R&D team will outline the requirements of this.
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