Investigational Medicinal Products IMP

Based on Fimea Regulation 1/2007 ann 2/2012 (2012 only in FInnish) Clinical Trials on Medicinal Products in Human Subjects, an investigational medicinal product (IMP) used in a clinical trial can be a pharmaceutical form of an active substance, or placebo, being tested or used as a reference. The investigational medicinal product can be a product already granted a marketing authorization but which is used for a different purpose or in a form (formulation or package) other than that initially approved, or used for an unapproved indication, or to obtain further information about the authorized pharmaceutical form.  A clinical trial can also involve other medications, called as Non-Investigational Medicinal Products (NIMP), specified in the protocol, in addition to the actual investigational medicinal products.  The fact, whether the product is an investigational or non-investigational medicinal product has an impact, for example, on the labeling requirements of the product, on medicinal product logistic and therefore also on the contents of pharmacy services, including documentation requirements. More specific information about the classification of medicinal products in clinical trials is available in EU regulation.

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