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.

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Assessors' assessment templates with guidance

Ancillary - Day 80 Quality template rev.10.16

Reference Number: rev.10.16 Legal effective date: 20/11/2016

Ancillary - Day 80 Non-clinical and clinical template rev.10.16

Reference Number: rev.10.16 Legal effective date: 20/11/2016

Ancillary - Day 80 Overview template rev.10.16

Reference Number: rev.10.16 Legal effective date: 20/11/2016

Ancillary - Day 150 JAR Quality template rev.10.16

Reference Number: rev.10.16 Legal effective date: 20/11/2016

Ancillary - Day 150 JAR Non-clinical and clinical template rev.10.16

Reference Number: rev.10.16 Legal effective date: 20/11/2016

Ancillary - Day 150 JAR Overview template rev.10.16

Reference Number: rev.10.16 Legal effective date: 20/11/2016

Ancillary - Day 180 JAR Quality template rev.10.16

Reference Number: rev.10.16 Legal effective date: 20/11/2016

Ancillary - Day 180 JAR Non-clinical and clinical template rev.10.16

Reference Number: rev.10.16 Legal effective date: 20/11/2016

Ancillary - Day 180 JAR Overview template rev.10.16

Reference Number: rev.10.16 Legal effective date: 20/11/2016

CHMP assessment report templates

Ancillary - CHMP Day 120 LoQ rev.10.16

Reference Number: rev.10.16 Legal effective date: 20/11/2016

Ancillary - CHMP Day 180 LoQ rev.10.16

Reference Number: rev.10.16 Legal effective date: 20/11/2016

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