Requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of asthma in children and adolescents

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Current effective version

Revision 1 - Adopted guideline

Currently under revision

Reference numberCPMP/EWP/4151/00 Rev. 1
Published22/01/2009
Effective from01/08/2009
KeywordsOrally inhaled products (OIP)
DescriptionThis document clarifies the requirements for clinical documentation for abridged applications for orally inhaled formulations and variations/extensions to a marketing authorisation. It applies to single active substance products and combination products, in respect of the demonstration of therapeutic equivalence between two inhaled products for use in the management and treatment of asthma and chronic obstructive pulmonary disease in adults and the management and treatment of asthma in children and adolescents.


Document history

Revision 2

 

Concept peper

Published: 22/03/2017

 

Deadline for consultation: 30/06/2017

Revision 1

Current version

Adopted guideline


 

Overview of comments


 

Draft guideline


 

Draft appendix 1

In operation: 01/08/2009-present


 

Published: 20/09/2010


 

Published: 18/10/2007


 

Published: 19/03/2008

First versionPoints to considerIn operation: 01/10/2004–31/07/2009


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