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:
- CHMP SmPC implementation plan
- Mandate and rules of procedure
- SmPC AG 2010-2015 activity report
- SmPC AG 6-year activity report (2016)
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.
- Doreen Fagan
- Agnes Gyurasics
- Kirstine Moll Harboe
- Nicole Kavanagh
- Peter Kiely
- Rita Offermann
- Patrick Vrijlandt
- Anna Wachnik-Święcicka
- Siri Wang
- Dominique Westphal