Definition
In Italian law, a medicinal product is a pharmaceutical preparation with packaging, label and package leaflet.
According to Legislative Decree 219/06, the term medicine or medicinal product means:
– any substance or combination of substances presented as having curative or prophylactic properties for human disease;
– any substance or combination of substances which may be used on or administered to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
The medicinal product consists of one or more active ingredients, which are responsible for the pharmacological, immunological or metabolic action, and excipients that do not contribute directly to the actions just mentioned but ensure the quality, efficacy and safety of the medicinal product and may alter the rate, time or place of release of the active ingredient. Infact, the active ingredient cannot be administered as such and through the use of excipients and a suitable formulation is transformed into a pharmaceutical preparation suitable to be administered via the desired route of administration.
