A generic medicine is an alternative to a medicine that has already been placed on the market, i.e. the reference, or innovative, medicine. The generic and reference medicines contain the same active substance in the same dose and are administered via the same route.
When the patent on a reference medicine has expired (when the period of exclusivity is over) other pharmaceutical manufacturers can introduce their own generic products to the market.
Generic medicines must meet the same strict criteria with regard to the ingredients used, the manufacturing process and the final medicinal product as the reference medicine. Strict quality standards have been set by the EU and are monitored by national regulatory authorities (the Finnish Medicines Agency Fimea in Finland), the European Medicines Agency (EMA) and the European Commission. This promotes consumer confidence in generic medicines.
The generic medicine may differ from the reference medicine in terms of its appearance, colour or shape. Different generic medicines may also look different from one another. Manufacturers may use different inactive ingredients and colouring agents and the final product may also have a different shape. Despite these variations, all generic preparations must meet the same strict regulatory requirements, designed to ensure the safety of the products.