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)">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:

Implementation plan of the Summary of Product Characteristics (SmPC) guideline

Reference Number: EMA/655980/2008Summary:

The objectives of the implementation plan are to increase awareness and harmonised application of the SmPC guideline by all involved parties, including assessors, scientific administrators, Committees and working parties’ members, and, pharmaceutical industry.

Mandate, objectives and rules of procedure for the Summary of Product Characteristics (SmPC) Advisory Group

Reference Number: EMA/125968/2009Summary:

The SmPC Advisory Group is established to provide CHMP and CMD(h) members and assessors, as well as the European Medicines Agency scientific administrators with advice on all matters relating to the SmPC guideline.

Summary of Product Characteristics Advisory Group (SmPC AG) 6-year activity report (2016)

Reference Number: EMA/151145/2017

Summary of Product Characteristics Advisory Group 2010-2015 activity report

Reference Number: EMA/748160/2015Summary:

During the public consultation for the second revision of the SmPC guideline in 2008, healthcare professionals supported the principles of the guideline and welcomed any initiative to improve the clarity of the SmPCs to favour daily medical practices.

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.

• Anna Katharina Baumann
• Doreen Fagan
• Nicole Kavanagh
• Monica Martinez Redondo
• Rita Offermann
• Alexandrina Preda
• Patrick Vrijlandt
• Siri Wang
• Dominique Westphal