Summary of Product Characteristics Advisory Group
The Summary of Product Characteristics Advisory Group (SmPC AG) promotes and facilitates the application of the guideline on summary of product characteristics (SmPC).
It provides advice on all matters relating to the SmPC guideline to the members of the Committee for Medicinal Products for Human Use (CHMP) and Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) and assessors, as well as European Medicines Agency scientific administrators.
Implementation plan, mandate and activity report
More information on the SmPC AG's responsibilities is available in these documents:
-
List item
Implementation plan of the Summary of Product Characteristics (SmPC) guideline (PDF/149.7 KB)
First published: 08/01/2013
Last updated: 08/01/2013
EMA/655980/2008 -
List item
Mandate, objectives and rules of procedure for the Summary of Product Characteristics (SmPC) Advisory Group (PDF/145.79 KB)
First published: 08/01/2013
Last updated: 08/01/2013
EMA/125968/2009 -
List item
Summary of Product Characteristics Advisory Group (SmPC AG) 6-year activity report (2016) (PDF/79.26 KB)
First published: 27/03/2017
Last updated: 27/03/2017
EMA/151145/2017 -
List item
Summary of Product Characteristics Advisory Group 2010-2015 activity report (PDF/144.02 KB)
First published: 07/07/2016
Last updated: 07/07/2016
EMA/748160/2015
Members
Below (in alphabetical order of surname) are the current members of the SmPC AG. The members' declarations of interests are available in the European expert list.
Members
- Anna Katharina Baumann
- Doreen Fagan
- Nicole Kavanagh
- Željana Margan Koletić
- Rita Offermann
- Patrick Vrijlandt
- Anna Wachnik-Święcicka
- Siri Wang
- Dominique Westphal