This document describes decision of the Executive Director
On fee reductions for designated orphan medicinal products
Orphan Medicines
This document is the IRIS guide for applicants
(how to create and submit scientific applications, for industry and individual
applicants)
This document is the IRIS guide to registration
Preliminary requirements for all IRIS submissions, including
substance and Research Product Identifier registration
EMA_Procedural Advice Appeal Procedure Orphan Designation Review_2020
Published by EMA
Orphan Medicinal ProductMarketing AuthorisationAppealProcedure AdviceThis document describes procedural advice on appeal procedure for orphan
medicinal product designation or review of orphan
designation criteria at the time of marketing authorisation
This document summarises the conference “Medicines for Rare Diseases and Children: Learning from the Past, Looking to the
Future”
This docment is the Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products
View this resource Bookmark this resourceThis document is the 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 ‘similar medicinal product’
and‘clinical superiority’