Generic medicines

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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.

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 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.

Documents of interest

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