European Medicines Agency

 

 

 

 

 

 

 

The 2015 annual report of ‘EMA interactions with patients, consumers and healthcare professionals and their organisations’ has been published and can be found on the dedicated pages for Patients and Consumers and Healthcare Professionals.

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The European Medicines Agency published the annual report of 2015. The report focuses on the Agency’s core tasks which include the evaluation of medicines, support to research and development of new and innovative treatments and the monitoring of the benefits and risks of medicines in real life.

The annual report is available by clicking here.

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The European Medicines Agency has released for public consultation a reflection paper on collecting and reporting information on off-label use in pharmacovigilance.

This paper outlines a proposal for the collection and reporting of information on off-label use by Marketing Authorisation Holders (MAHs) in relation to their pharmacovigilance obligations provided in Title IX of Directive 2001/83/EC. It follows 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 (See Annex 3).The proposal distinguishes the situations where the off-label use of a medicinal product results in the occurrence of a suspected adverse reaction and those where it does not. It incorporates the feedback of the Pharmacovigilance Risk Assessment Committee (PRAC). Some Member States may already have put in place specific national guidance regarding the notification by MAHs of practices of off-label use of medicines at national level; the draft proposal presented here should not be interpreted as preventing the fulfilment by MAHs of national obligations.

The document open for consultation is available by clicking here.

Comments should be provided using this template. The completed comments form should be sent to consultation_reporting_off_label_use@ema.europa.eu.

The deadline for comments is 29 July 2016.