This document describes decision of the Executive Director
On fee reductions for designated orphan medicinal products
Orphan medicines
Commission Notice 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 2022/C 440/02
Published by European Commission (EC)
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
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European Medicines Agency Guidance for Applicants seeking scientific advice and protocol assistance
Published by EMA
protocol assistanceScientific AdviceThis guidance document addresses a number of questions that users of the scientific advice or protocol assistance procedures may have.
View this resource Bookmark this resourceThis document is the IRIS guide for applicants
(how to create and submit scientific applications, for industry and individual
applicants)
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
EC_Joint Evaluation of the Orphan and Paediatric Regulations_2020
Published by European Commission (EC)
Drug SurveillanceDrugs ClassificationGeneric DrugInnovationMarket ApprovalMedical ResearchOrphan DiseaseOrphan DrugPaediatricsTherapeuticsThis document is a joint evaluation on orphan medicinal products
View this resource Bookmark this resourceThis 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
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
This document summarises the conference “Medicines for Rare Diseases and Children: Learning from the Past, Looking to the
Future”
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
