Response to: DELEGATED ACT ON POST-AUTHORISATION EFFICACY STUDIES

Year: 
2013
Authors: 
Chair: Marlene Sinclair WG members: Marta Andreykiv, Philippe Autier (alternate: Markus Pasterk), Ulf Bergman, Martin Daumer, Vera Ehrenstein, Pierre Engel, Danilo Fusco, Yvonne Lis, Ignacio Mendes (alternate: Nawab Qisilbash), Fran├žois Meyer (Vice Chair), Nicholas Moore (alternate: Antoine Pariente), Maarten Postma, Eckart Ruether, Massoud Toussi (alternate: Maartje Smulders), Eric Van Ganse, Tjeerd van Staa

Response to:

DELEGATED ACT ON POST-AUTHORISATION EFFICACY STUDIES

(ARTICLE 10B OF REGULATION (EC) NO 726/2004 AND ARTICLE 22B OF DIRECTIVE 2001/83/EC)

POST-AUTHORISATION EFFICACY STUDIES

Ref. Ares(2012)1405774 - 28/11/2012