generic medicinal product
- Guideline or reference source
- EMA Glossary of terms
- Definition
- A generic medicine is a medicine that is developed to be the same as a medicine that has already been authorised. Its authorisation is based on efficacy and safety data from studies on the authorised medicine. A company can only market a generic medicine once the 10-year exclusivity period for the original medicine has expired.
- Used For
- generic drug
- generic medicine
- Narrower Term
- branded generics
- Related Term
- generic substitution
- interchangeable
- market protection
- multi-source medicine
- off-patent medicine
- reference listed drug
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