medicinal product

A medicinal product is the finished, labelled medicine that a patient or pharmacist actually receives: the box of tablets with its leaflet, the bottle of syrup, the vial of injection. It is the end of the pharmaceutical chain, where the active drug, its delivery vehicle and its packaging come together as a regulated whole.

The term carries legal and regulatory weight. A medicinal product is something presented as having properties for treating or preventing disease, and as such it must be authorized by a regulator, manufactured under Good Manufacturing Practice, and supplied with a defined specification, shelf life and labelling.

Crucially, a medicinal product is more than its API. It is a specific formulation, made by a specific process, in a specific container-closure system, with a defined strength and dosage form. Change any of these and you may have a different product requiring fresh approval, which is why regulatory dossiers describe products in such fine detail.