Generic and hybrid medicines
The European Medicines Agency (EMA) assesses applications from companies to market generic medicines in the European Union (EU). A generic medicine is developed to be the same as a medicine that has already been authorised, called the reference medicine.
A generic medicine contains the same active substance(s) as the reference medicine, and it is used at the same dose(s) to treat the same disease(s). However, a generic medicine's inactive ingredients, name, appearance and packaging can be different.
Generic medicines are manufactured according to the same quality standards as all other medicines.
A company can only submit a marketing authorisation application for a generic medicine once the period of data exclusivity of the reference medicine has expired. Generics can only be marketed once the marketing protection had expired, usually from 10 or 11 years from the date of first authorisation of the reference product.
For the list of generic medicines approved via the Agency, see:
EMA assesses applications if the reference medicine was centrally authorised or if the generic medicine provides a significant innovation or advantage for patients.
- provide information on the quality of the medicine;
- demonstrate that the generic medicine produces the same levels of the active substance in the human body as the reference medicine.
After they have been authorised, the Agency monitors the safety of generic medicines.
This happens when a manufacturer develops a generic medicine that is based on a reference medicine, but has a different strength, a different route of administration or a slightly different indication from the reference medicine.