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 diseas...

Current effective version

PDF iconRevision 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

PDF iconConcept peper

Published: 22/03/2017

Deadline for consultation: 30/06/2017

Revision 1

Current version

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline


PDF iconDraft appendix 1

In operation: 01/08/2009-present


Published: 20/09/2010


Published: 18/10/2007


Published: 19/03/2008

First version PDF iconPoints to consider In operation: 01/10/2004–31/07/2009


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