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
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)

Application guidance and procedural information
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
EMEA/14222/00 Procedures for orphan medicinal product designation - General principles (Rev. 4 of 23/06/08)
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)
EMEA/114593/07 Practical information for sponsors during the early phase of an orphan drug application (Rev. 3 of June 2008)
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)
EMEA/4795/00 General information for sponsors of orphan medicinal products (Rev. 4 of 23/06/08)
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