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:

Agency role

EMA assesses applications if the reference medicine was centrally authorised or if the generic medicine provides a significant innovation or advantage for patients.

Since information on the safety and efficacy of the active substance(s) is already available from the reference medicine, companies producing generic medicines usually only need to:

  • 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.

Procedural advice

Applicants preparing to request marketing authorisation for a generic medicine via EMA should follow the Agency's procedural advice for the centralised authorisation of generic and hybrid medicines.

Hybrid medicines

Hybrid medicines are medicines whose authorisation depends partly on the results of tests on the reference medicine and partly on new data from clinical trials.

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.

Related documents


How useful was this page?

Add your rating
37 ratings
15 ratings
7 ratings
8 ratings
13 ratings