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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

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

Scientific Advice protocol assistance

This guidance document addresses a number of questions that users of the scientific advice or protocol assistance procedures may have.

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EC_Joint Evaluation of the Orphan and Paediatric Regulations_2020

Published by European Commission (EC)

Innovation Orphan Drug Medical Research Paediatrics Drug Surveillance Drugs Classification Generic Drug Market Approval Orphan Disease Therapeutics

This document is a joint evaluation on orphan medicinal products

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EMA_Checklist Transfer Orphan Designation_2020

Published by EMA

Transfer Sponsors Orphan Medicinal Product

This document makes a checklist for sponsors applying for the transfer of Orphan
Medicinal Product (OMP) designation

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EMA_Decision Fee Reductions_2020

Published by EMA

Orphan Medicinal Product Fee Reductions

This document describes decision of the Executive Director
On fee reductions for designated orphan medicinal products

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EMA_IRIS Guide for Applicants_2021

Published by EMA

Applicant IRIS Guide Scientific Application

This document is the IRIS guide for applicants
(how to create and submit scientific applications, for industry and individual
applicants)

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EMA_IRIS_Guide Registration_2021

Published by EMA

IRIS Guide Registration

This document is the IRIS guide to registration
Preliminary requirements for all IRIS submissions, including
substance and Research Product Identifier registration

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EMA_Procedural Advice Appeal Procedure Orphan Designation Review_2020

Published by EMA

Orphan Medicinal Product Marketing Authorisation Procedure Advice Appeal

This document describes procedural advice on appeal procedure for orphan
medicinal product designation or review of orphan
designation criteria at the time of marketing authorisation

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EV_Report_Medicines for Rare Diseases and Children_2019

Published by EMA

Rare Disease Children

This document summarises the conference “Medicines for Rare Diseases and Children: Learning from the Past, Looking to the
Future”

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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

European Medicines Agency Guidance for Applicants seeking scientific advice and protocol assistance

EMA_Guidance Procedural Advice Orphan Designation_2021

EC_Joint Evaluation of the Orphan and Paediatric Regulations_2020

EMA_Checklist Transfer Orphan Designation_2020

EMA_Decision Fee Reductions_2020

EMA_IRIS Guide for Applicants_2021

EMA_IRIS_Guide Registration_2021

EMA_Procedural Advice Appeal Procedure Orphan Designation Review_2020

EV_Report_Medicines for Rare Diseases and Children_2019

IMT Cookie Overview