Consenting and Treatment Compliance
The definition of an “investigational medicinal product” (IMP) is provided in Subsidiary legislation 458.43, as “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… ................
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