Assessment templates and guidance - Ancillary medicinal substances incorporated in a medical device

This page lists the Committee for Medicinal Products for Human Use (CHMP) assessment report template and guidance documents used for the assessment of an ancillary medicinal substance incorporated in a medical device.

For queries or comments on templates, please contact: chmp_ar_templates@ema.europa.eu

Assessors' assessment templates with guidance

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Ancillary - Day 80 Quality template rev.10.16 (DOC/161 KB)

First published: 10/05/2012
Last updated: 08/11/2016
Legal effective date: 20/11/2016
rev.10.16
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Ancillary - Day 80 Non-clinical and clinical template rev.10.16 (DOC/91.5 KB)

First published: 10/05/2012
Last updated: 08/11/2016
Legal effective date: 20/11/2016
rev.10.16
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Ancillary - Day 80 Overview template rev.10.16 (DOC/106 KB)

First published: 10/05/2012
Last updated: 08/11/2016
Legal effective date: 20/11/2016
rev.10.16
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Ancillary - Day 150 JAR Quality template rev.10.16 (DOC/85 KB)

First published: 10/05/2012
Last updated: 08/11/2016
Legal effective date: 20/11/2016
rev.10.16
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Ancillary - Day 150 JAR Non-clinical and clinical template rev.10.16 (DOC/83.5 KB)

First published: 10/05/2012
Last updated: 08/11/2016
Legal effective date: 20/11/2016
rev.10.16
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Ancillary - Day 150 JAR Overview template rev.10.16 (DOC/120 KB)

First published: 10/05/2012
Last updated: 08/11/2016
Legal effective date: 20/11/2016
rev.10.16
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Ancillary - Day 180 JAR Quality template rev.10.16 (DOC/96 KB)

First published: 10/05/2012
Last updated: 08/11/2016
Legal effective date: 20/11/2016
rev.10.16
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Ancillary - Day 180 JAR Non-clinical and clinical template rev.10.16 (DOC/96.5 KB)

First published: 10/05/2012
Last updated: 08/11/2016
Legal effective date: 20/11/2016
rev.10.16
List item

Ancillary - Day 180 JAR Overview template rev.10.16 (DOC/116 KB)

First published: 10/05/2012
Last updated: 08/11/2016
Legal effective date: 20/11/2016
rev.10.16

CHMP assessment report templates

Assessment report templates and guidance documents used for the assessment of any new drug application in the centralised procedure

Assessment templates and guidance - Ancillary medicinal substances incorporated in a medical device

Table of contents

Assessors' assessment templates with guidance

Ancillary - Day 80 Quality template rev.10.16 (DOC/161 KB)

Ancillary - Day 80 Non-clinical and clinical template rev.10.16 (DOC/91.5 KB)

Ancillary - Day 80 Overview template rev.10.16 (DOC/106 KB)

Ancillary - Day 150 JAR Quality template rev.10.16 (DOC/85 KB)

Ancillary - Day 150 JAR Non-clinical and clinical template rev.10.16 (DOC/83.5 KB)

Ancillary - Day 150 JAR Overview template rev.10.16 (DOC/120 KB)

Ancillary - Day 180 JAR Quality template rev.10.16 (DOC/96 KB)

Ancillary - Day 180 JAR Non-clinical and clinical template rev.10.16 (DOC/96.5 KB)

Ancillary - Day 180 JAR Overview template rev.10.16 (DOC/116 KB)

CHMP assessment report templates

Ancillary - CHMP Day 120 LoQ rev.10.16 (DOC/210 KB)

Ancillary - CHMP Day 180 LoQ rev.10.16 (DOC/204.5 KB)

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