Generic and hybrid medicines

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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 develop a generic medicine for marketing once the period of data exclusivity on the reference medicine has expired. This is usually 10 years from the date of first authorisation.

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 genericmedicine 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

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Document(s) Language Status First published Last updated Effective Date
Questions and answers on generic medicines BG = bălgarski   2007-07-09 2012-12-07  
Questions and answers on generic medicines ES = español   2007-07-09 2012-12-07  
Questions and answers on generic medicines CS = čeština   2007-07-09 2012-12-07  
Questions and answers on generic medicines DA = dansk   2007-07-09 2012-12-07  
Questions and answers on generic medicines DE = Deutsch   2007-07-09 2012-12-07  
Questions and answers on generic medicines ET = eesti keel   2007-07-09 2012-12-07  
Questions and answers on generic medicines EL = elliniká   2007-07-09 2012-12-07  
Questions and answers on generic medicines EN = English   2007-07-09 2012-12-07  
Questions and answers on generic medicines FR = français   2007-07-09 2012-12-07  
Questions and answers on generic medicines IT = italiano   2007-07-09 2012-12-07  
Questions and answers on generic medicines LV = latviešu valoda   2007-07-09 2012-12-07  
Questions and answers on generic medicines LT = lietuvių kalba   2007-07-09 2012-12-07  
Questions and answers on generic medicines HU = magyar   2007-07-09 2012-12-07  
Questions and answers on generic medicines MT = Malti   2007-07-09 2012-12-07  
Questions and answers on generic medicines NL = Nederlands   2007-07-09 2012-12-07  
Questions and answers on generic medicines PL = polski   2007-07-09 2012-12-07  
Questions and answers on generic medicines PT = português   2007-07-09 2012-12-07  
Questions and answers on generic medicines RO = română   2007-07-09 2012-12-07  
Questions and answers on generic medicines SK = slovenčina   2007-07-09 2012-12-07  
Questions and answers on generic medicines SL = slovenščina   2007-07-09 2012-12-07  
Questions and answers on generic medicines FI = suomi   2007-07-09 2012-12-07  
Questions and answers on generic medicines SV = svenska   2007-07-09 2012-12-07  
Questions and answers on generic medicines HR = Hrvatski   2007-07-09 2012-12-07