This document describes decision of the Executive Director
On fee reductions for designated orphan medicinal products
Orphan Medicinal Product
EMA_Checklist Transfer Orphan Designation_2020
Published by EMA
Orphan Medicinal ProductSponsorsTransferThis document makes a checklist for sponsors applying for the transfer of Orphan
Medicinal Product (OMP) designation
EMA_Procedural Advice Appeal Procedure Orphan Designation Review_2020
Published by EMA
AppealMarketing AuthorisationOrphan Medicinal ProductProcedure 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
EMA_Guidance Procedural Advice Orphan Designation_2021
Published by EMA
Orphan Medicinal ProductSponsorThis document describes the procedural advice for orphan medicinal product
designation
Guidance for sponsors
This 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’
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
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