Data exclusivity / Generics / Biosimilars: Regulatory and procedural guidance
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Best practice guidance on the common principle for collaboration between CMDh / reference Member States and the European Medicines Agency on generics and hybrids (PDF/76.83 KB)
First published: 04/12/2012
Last updated: 04/12/2012
EMA/234449/2012 -
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European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (PDF/297.23 KB)
First published: 02/07/2008
Last updated: 13/01/2021
EMEA/CHMP/225411/2006
- 'Procedures for marketing authorisation', the Rules governing Medicinal Products in the European Community, Notice to Applicants, Volume 2A, Chapter 1
- Guidance on elements required to support the significant clinical benefit in comparison with existing therapies of a new therapeutic indication in order to benefit from an extended (11 years) marketing protection period
- Guidance on new therapeutic indication for a well-established substance
- Guideline on changing the classification for the supply of a medicinal product for human use