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)
---- 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
* 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)

abrir aquí para acceder al documento EMEA completo:
European Medicines Agency - Human Medicines - Orphan medicinal products - Orphan designation - Application guidance and related information