ICH: Safety

Published by EMA International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Reproductive Toxicology Nonclinical Safety in Paediatric Medicine Genotoxicity Study Carcinogenicity Study Toxicokinetics and Pharmacokinetics Repeat-Dose Toxicity Biotechnological Product Safety Pharmacology Study Immunotoxicology Study Therapeutic Area-Specific Photosafety Evaluation

The European Medicines Agency publishes scientific guidelines on human medicines that are harmonised by the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

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EMA_Checklist Transfer Orphan Designation_2020

Published by EMA

Sponsors Transfer 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

IRIS Guide Scientific Application Applicant

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

Procedure Advice Appeal Marketing Authorisation Orphan Medicinal Product

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

Children Rare Disease

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

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REGULATION (EC) No 141 2000

Published by EMA

Orphan Medicinal Product

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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REGULATION (EC) No 847 2000

Published by EMA

Orphan Medicinal Product Provision

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’

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ICH: Safety

EMA_Guidance Procedural Advice Orphan Designation_2021

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

REGULATION (EC) No 141 2000

REGULATION (EC) No 847 2000

IMT Cookie Overview