Orphan Drugs

 

 
Title Link
European DG Enterprise - Inventory of Community and national incentive measures to aid the research, marketing, development and availability of orphan medicinal products - (17 pages) http://pharmacos.eudra.org/F2/orphanmp/doc/inventory/Inventory-en.pdf 
Draft 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, revision December 2000 http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2000/dec/format-content-rev3.pdf 
COMMISSION REGULATION (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts http://pharmacos.eudra.org/F2/orphanmp/doc/rev1/en1.pdf 

 

 

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