A generic medicine is a medicine that 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 substances as the reference medicine, and it is used at the same doses to treat the same diseases. However, a generic medicine's inactive ingredients, name, appearance and packaging can be different from the reference medicine's.
Generic medicines are manufactured according to the same quality standards as all other medicines.
A company can only develop a generic medicine for marketing once the period of exclusivity on the reference medicine has expired. This is usually 10 years from the date of first authorisation.
Role of the European Medicines Agency
The European Medicines Agency is responsible for assessing applications from companies to market generic medicines in the European Union (EU). It assesses applications if:
- the reference medicine was authorised centrally via the Agency, or;
- the generic medicine provides a significant innovation or advantage for patients or animals.
Because information is already available on the safety and efficacy of the active substances 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 body as the reference medicine.
See the list of human generic medicines authorised via the Agency (opens in new window).
As for all medicines, the Agency monitors the safety of generic medicines after they have been authorised.
- For more information, see the regulatory questions and answers on generic and hybrid applications.
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 or is given by a different route, such as by mouth or as an injection. It also happens when a manufacturer develops a medicine with a slightly different indication from the reference medicine.