European Medicines Agency - Human Medicines - Orphan medicinal products - Orphan designation - Application guidance and related information

Human medicines - Orphan medicinal products
Orphan designation - Application guidance and related information
Application form and deadlines for submission

. EMA/22383/2010 Electronic submission of applications for orphan designation Updated on lunes, 25 de enero de 2010
.. Annex to ENTR/6283/00 Application form for orphan medicinal product designation (in Word format) (Annex to Guideline on the format and content of applications for designation as orphan medicinal products - October 2006)
... EMEA/COMP/153915/09 Deadlines for submission of applications for Orphan Medicinal Product Designation to the EMEA 2009/2010
.... Common Application Form Common EMEA/FDA application form for Orphan Medicinal Product Designation (Published November 2007)
..... Translations required Translations required with submission of an application for orphan drug designation

Application guidance and procedural information
^EMEA/33143/09 Data providers and sources to identify existing authorised medicinal products in the European Union and European Economic Area
^ENTR/6283/00 Guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another (Rev. 3 July 2007)
^C(2008) 4051 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
^EMA/710915/09 Procedures for orphan medicinal product designation - General principles (Rev. 5 of Jan 2010) Updated on lunes, 25 de enero de 2010
^COMP/15893/09 Recommendation on elements required to support the medical plausibility and the assumption of significant benefit for an orphan designation
^COMP/436/01 Points to consider on the calculation and reporting of the prevalence of a condition for orphan designation (Final - adopted March 2002)
^EMA/710916/09 Practical information for sponsors during the early phase of an orphan drug application (Rev. 4 of Jan 2010) Updated on lunes, 25 de enero de 2010
^EMEA/2677/01 Procedural advice on appeal procedure for orphan medicinal product designation
^EMEA/COMP/150409/06 COMP members interaction with sponsors of applications for orphan designation

General information
- EMEA/290072/07 Orphan drugs and rare diseases at a glance (July 2007)
-- EMA/710917/09 General information for sponsors of orphan medicinal products (Rev. 5 of Jan 2010) Updated on lunes, 25 de enero de 2010
--- EMEA/422264/06 Note for sponsors of orphan medicinal products regarding enlargement of the European Union (October 2006)

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European Medicines Agency - Human Medicines - Orphan medicinal products - Orphan designation - Application guidance and related information