Clinical trials and compassionate use of medicinal products

Clinical trials of medicinal products for human use involves investigation in human subjects for the purpose of discovering or confirming clinical, pharmacological, and other pharmacodynamic and pharmacokinetic effects of the investigational medicinal product, or to discover undesired effects of the product or examine the absorption, distribution, metabolism and excretion of the investigational medicinal product in order to prove its safety and/or efficacy.

Compassionate use, as determined in Article 83 of Decree 726/2004/EC, means provision of a medicinal product with a new active ingredient which represents an important therapeutic, scientific, and technical innovation, and must be undergoing clinical trial or have entered the  centralised marketing-authorisation application process t, whereby it is made available to a group of patients with chronically or seriously debilitating disease which cannot be treated satisfactorily by an authorised medicinal product.

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