Data exclusivity / Generics / Biosimilars: Regulatory and procedural guidance

Best practice guidance on the common principle for collaboration between CMDh / reference Member States and the European Medicines Agency on generics and hybrids

Reference Number: EMA/234449/2012Summary:

The purpose of this document is to give guidance on exchange of information between EMA, CMDh and Member States (MS) in an efficient manner, in order to facilitate the identification of identical or similar generic and hybrid dossiers, and to ensure a consistent approach in their assessment.

European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications

Reference Number: 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