Quality of oral modified release products

Current effective version

PDF iconAdopted guideline

Reference number EMA/CHMP/QWP/428693/2013
Published 31/07/2014
Effective from 01/02/2015
Keywords Oral dosage form, modified release
Description This document concerns quality aspects of dosage forms in which the release of active substance is modified. It only covers prolonged release oral dosage forms and delayed release oral dosage forms with the principle of gastro-resistance.


Document history

First version

Current version

PDF iconAdopted guideline

 

PDF iconOverview of comments

 

PDF iconDraft guideline

In operation: 01/02/2015–present

 

Published: 16/12/2014

 

Published: 14/08/2012

Superseded document

PDF iconConcept paper

 

PDF iconAdopted guideline

Published: 30/07/2010

 

In operation: 01/01/2000–31/01/2015


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