Manufacture of the finished dosage form

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Current effective versionRevision 1 - Adopted guideline
Reference numberEMA/CHMP/QWP/245074/2015
Effective from14/02/2018
KeywordsManufacture, drug product
DescriptionThis document provides clarification on the type and level of information that should be included in the common technical document module 3 of the marketing authorisation application dossier with respect to the manufacturing process description. It also addresses aspects related to increased outsourcing and new manufacturing practices such as complex manufacturing chains or issues with prolonged holding times and transportation conditions.

Document history

Revision 1

Current version



Adopted guideline


Overview of comments


Draft guideline

Concept paper

In operation: 14/02/2018-present


Published: 17/11/2017 


Published: 09/07/2015

Published: 04/07/2013

First versionAdopted guideline
Published: 01/04/1996

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