Quality of oral modified release products

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/QWP/428693/2013
Effective from01/02/2015
KeywordsOral dosage form, modified release
DescriptionThis 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

Adopted guideline

Overview of comments

Draft guideline

In operation: 01/02/2015–present

Published: 16/12/2014

Published: 14/08/2012

Superseded document

Concept paper

Adopted guideline

Published: 30/07/2010

In operation: 01/01/2000–31/01/2015

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