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

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

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

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

Ancillary - Day 80 Overview template rev.10.16

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

Ancillary - Day 150 JAR Quality template rev.10.16

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

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

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

Ancillary - Day 150 JAR Overview template rev.10.16

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

Ancillary - Day 180 JAR Quality template rev.10.16

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

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

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

Ancillary - Day 180 JAR Overview template rev.10.16

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

CHMP assessment report templates

Ancillary - CHMP Day 120 LoQ rev.10.16

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

Ancillary - CHMP Day 180 LoQ rev.10.16

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

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