Application guidance and related information

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Application form and deadlines for submission

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Document(s) Language Status First published Last updated Effective Date
Deadlines for submission of applications for orphan medicinal product designation to the European Medicines Agency 2011/2012 (English only)   04/04/2011    
Application form for orphan medicinal product designation (English only)   24/11/2008    
Common European Medicines Agency/Food and Drug Administration application form for orphan medicinal product designation (English only)   24/11/2008    
Template for sections A to E for the scientific part of the application for orphan designation (English only) draft 14/10/2011 14/12/2011  
Translations required with submission of an application for orphan drug designation (English only)   09/12/2009 27/06/2011  
Practical information for sponsors during the early phase of an orphan drug application (English only)   24/06/2008 03/11/2010  

Application guidance and procedural information

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Document(s) Language Status First published Last updated Effective Date
Procedure for orphan medicinal product designation - general principles (English only)   23/06/2008 25/01/2010  
Recommendations on elements required to support medical plausibility and the assumption of significant benefit for an orphan designation (English only) draft: consultation closed 01/09/2004 21/03/2012  
Points to consider on the calculation and reporting of the prevalence of a condition for orphan designation (English only) adopted 22/03/2002    
Data providers and sources to identify existing authorised medicinal products in the European Union and European Economic Area (English only)   11/06/2009    
Procedural advice on appeal procedure for orphan medicinal product designation (English only)   04/05/2008    
COMP members interaction with sponsors of applications for orphan designation (English only)   12/07/2006    
Reflection paper on benefit-risk assessment methods in the context of the evaluation of marketing authorisation applications of medicinal products for human use (English only) adopted 18/03/2008    
Guideline on aspects of the application of Article 8(2) of Regulation (EC) No 141/2000: Review of the period of market exclusivity of orphan medicinal products (English only)   17/09/2008    

General information

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Document(s) Language Status First published Last updated Effective Date
Orphan medicines in numbers - The success of ten years of orphan legislation (English only)   20/05/2010    
Orphan drugs and rare diseases at a glance (English only)   03/07/2007    
General information for sponsors of orphan medicinal products (English only)   23/06/2008 25/01/2010  
Note for sponsors of orphan medicinal products regarding enlargement of the European Union (English only)   19/10/2006