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

  • Email
  • Help

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

Table of contents


Assessors' assessment templates with guidance

Back to top

Document(s) Language Status First published Last updated Effective Date
Ancillary - Day 80 Quality template rev.10.16 (English only)   2012-05-10 2016-11-08 2016-11-20
Ancillary - Day 80 Non-clinical and clinical template rev.10.16 (English only)   2012-05-10 2016-11-08 2016-11-20
Ancillary - Day 80 Overview template rev.10.16 (English only)   2012-05-10 2016-11-08 2016-11-20
Ancillary - Day 150 JAR Quality template rev.10.16 (English only)   2012-05-10 2016-11-08 2016-11-20
Ancillary - Day 150 JAR Non-clinical and clinical template rev.10.16 (English only)   2012-05-10 2016-11-08 2016-11-20
Ancillary - Day 150 JAR Overview template rev.10.16 (English only)   2012-05-10 2016-11-08 2016-11-20
Ancillary - Day 180 JAR Quality template rev.10.16 (English only)   2012-05-10 2016-11-08 2016-11-20
Ancillary - Day 180 JAR Non-clinical and clinical template rev.10.16 (English only)   2012-05-10 2016-11-08 2016-11-20
Ancillary - Day 180 JAR Overview template rev.10.16 (English only)   2012-05-10 2016-11-08 2016-11-20

CHMP assessment report templates

Back to top

Document(s) Language Status First published Last updated Effective Date
Ancillary - CHMP Day 120 LoQ rev.10.16 (English only)   2012-05-10 2016-11-08 2016-11-20
Ancillary - CHMP Day 180 LoQ rev.10.16 (English only)   2012-05-10 2016-11-08 2016-11-20