Reference product

A medicine which has been granted a marketing authorisation by a country or by the European Commission on the basis of submitted quality, pre-clinical and clinical data, to which the application for marketing authorisation for a generic or a biosimilar product refers. In the context of external price referencing, the reference product is the one which is referred in the price comparison.
Synonym: Reference Medicine

In German: Referenzprodukt
Jenes Arzneimittel innerhalb einer Referenzgruppe, dessen Preis dem Referenzpreis entspricht. Manchmal ist dies das kostengünstigste Produkt.

Last update: 30 June 2023

Source: PPRI