EMA issues reflection paper on off-label use

Published: 16-May-2016
Regulatory

Follows up questions raised by the EFPIA on the management of individual reports of off-label use not associated with harm to a patient


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 on 29 July.

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 proposal distinguishes between situations where the off-label use of a medicinal product results in a suspected adverse reaction and those where it does not, drawing on feedback from its ‘pharmacovigilance risk assessment committee’ (PRAC).

Noting that some EU countries had already put in place specific national guidance on the matter, the EMA said its draft proposal 'should not be interpreted as preventing the fulfilment by MAHs of national obligations'.

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