15 June 2017 EMA/MB/109400/2017 Noted Management Board meeting of 14-15 June 2017

Outcome of written procedures finalised during the period from 14 February 2017 to 11 May 2017 Issues for consideration This document is presented in accordance with Article 4 (5) of the Management Board rules of procedure regarding the outcome of the written procedures. During the period from 14 February 2017 to 11 May 2017, the Board was consulted eight times via written procedure, of which five consultations concerned new memberships in the CVMP and CHMP, and three additional consultations , as listed: •

Consultation no 08/2017 on the appointment of Svein Rune Andersen as CHMP member, proposed by Norway ended on 10 March 2017. The mandate of the nominee commenced on 13 March 2017



Consultation no 09/2017 on the appointment of Maja Turk as CVMP alternate, proposed by Slovenia, ended on 10 March 2017. The mandate of the nominee commenced on 13 March 2017.



Consultation no 10/2017 Jorge Camarero Jimenez as CHMP alternate, proposed by Spain, ended on 17 March 2017. The mandate of the nominee commenced on 20 March 2017.



Consultation no 11/2017 Gesine Hahn as CVMP member, proposed by Germany, ended on 20 March 2017. The mandate of the nominee commenced on 21 March 2017.



Consultation no 12/2017 on the appointment of Adriana Adameova as CHMP member, proposed by Germany, ended on 8 May 2017. The mandate of the nominee commenced on 10 May 2017.



Consultation for endorsement of Final Report on MB Data Gathering exercise, ended on the 29 March 2017. The report was endorsed



Written procedure for adoption of the 95th Management Board meeting minutes, ended on 28 April 2017. The minutes were adopted.



Written procedure for adoption of Confirmation and announcement of full functionality of the Eudravigilance database, ended on 19 May 2017. The report was adopted

In accordance with the Board’s decision of 18 March 2010 relating to the Procedure for the consultation of the Management Board on new appointments of CHMP and CVMP members and alternates (EMA/MB/353835/Rev.2), the Board shall be provided with a periodic overview of renewed memberships in the CHMP and CVMP. Renewed memberships include also those memberships where the member has been re-nominated as an alternate or vice versa:

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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

Country

Name

Membership 1

Committee

Bulgaria

Emil Kozhuharov

Member

CVMP

Iceland

Hrefna Guðmundsdóttir

Alternate

CHMP

Lithuania

Rugile Pilviniene

Alternate

CHMP

Norway

Hanne Bergendahl

Member

CVMP

Norway

Tonje Hoy

Alternate

CVMP

Sweden

Filip Josephson

Alternate

CHMP

1

Membership referred in this column is the membership that was indicated in the nominating correspondence.

Outcome of written procedures finalised during the period from 14 February 2017 to 11 May 2017 EMA/MB/109400/2017

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