Quality: Active substance

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TopicDocumentsReference numberPublication dateEffective dateRemarks
Quality Working Party questions and answers on API mix PDF iconQuestions and answers EMA/CHMP/CVMP/QWP/152772/201621 April 2016
Requirements for selection and justification of starting materials for the manufacture of chemical active substances PDF iconReflection paper EMA/448443/2014October 2014
Use of cocrystals of active substances in medicinal products

PDF iconOverview of comments

PDF iconReflection paper

PDF iconDraft reflection paper

EMA/CHMP/CVMP/QWP/284008/2015Jul 2015Jun 2015
Active Substance Master File Procedure

PDF iconAdopted guideline

Microsoft Office document iconTemplate (annexes)

PDF iconOverview of comments

PDF iconDraft guideline

CVMP/134/02 Rev. 3 CorrJul 2012 Oct 2012 PDF iconAdditional guidance on documents relating to an active substance master file (02/10/2012)
Active Substance Master File Procedure PDF iconDraft guideline CPMP/QWP/227/02 Rev. 2 Superceded by Rev. 3
Recommendation on the assessment of the quality of medicinal products containing existing/ known active substances PDF iconDocument of interest CHMP/CVMP/QWP/450653/2006Feb 2009
Template for the qualified person's declaration concerning GMP compliance of active substance manufacture "The QP declaration template"

PDF iconOverview of comments

PDF iconTemplate guidance

Microsoft Office document iconTemplate

PDF iconDraft template

PDF iconDraft questions and answers

EMA/334808/2014 June 2014

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