EMA ISSUES REFLECTION PAPER ON OFF-LABEL USE
May 1st, 2016
The European Medicines Agency (EMA) has issued a ‘reflection paper’ outlining a proposal for the collection and reporting of information on off-label use by ‘marketing authorisation holders’ (MAHs) in relation to their pharmacovigilance obligations set by Directive 2001/83/EC. Public consultations, now open, will end July 29th.
The paper follows up questions raised by the European Federation of Pharmaceutical Industries and Associations (EFPIA) on the management of individual reports of off-label use not associated with harm to a patient. The EMA ...
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