Clinical development of medicinal products for treatment of HIV infection

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Current effective version

Revision 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

 

Adopted guideline

 

Overview of comments

 

Draft guideline


Concept paper

In operation: 01/01/2017-present

 

Published: 12/07/2016

 

Published: 30/09/2013


Published: 15/11/2011

Revision 2

 

 

Adopted guideline


Overview of comments


Draft guideline


Concept paper


Concept paper - Annex A


Concept 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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