Clinical development of medicinal products for treatment of HIV infection

Current effective version

PDF iconRevision 3 - Adopted guideline

Reference numberCPMP/EWP/633/2002 Rev. 3
Published12/07/2016
Effective from01/01/2017
KeywordsHuman immunodeficiency virus (HIV), HIV infection, acquired immune-deficiency syndrome (AIDS), anti-retroviral therapy
DescriptionThis document provides guidance on the clinical development of medicinal products for the treatment of HIV infection. It also concern the requirements for authorisation and wording of the summary of products characteristics.


Document history

Revision 3

Current version

PDF iconAdopted guideline

PDF iconOverview of comments

PDF iconDraft guideline


PDF iconConcept paper

In operation: 01/01/2017-present

Published: 12/07/2016

Published: 30/09/2013


Published: 15/11/2011

Revision 2

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper


PDF iconConcept paper - Annex A


PDF iconConcept paper - Annex B

Published: 01/06/2009


Published: 04/02/2009


Published: 18/10/2007


Published: 22/02/2007


Published: 22/02/2007


Published: 01/10/2012


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