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Regulatory Focus™ > News Articles > Consultation Opened on Impact of 'Black Symbol' on Industry

Consultation Opened on Impact of 'Black Symbol' on Industry

Posted 26 November 2012 | By Ansis Helmanis

The European Commission has opened a consultation on the time needed by companies to implement product packaging changes under the new EU pharmacovigilance law.

Under that legislation, companies are required to incorporate a black symbol on certain drug products subject to additional monitoring because of their specific safety profile.

The Commission is considering the need for phasing in the black symbol in the summary of product characteristics (SmPC) and the package leaflet of products.

The concept paper for public consultation invites stakeholders to comment on how much time a marketing authorization holder needs to adapt and print the updated product information (summary of product characteristics and patient leaflet. Comments must be submitted by 10 January 10 2013.


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