Europe Considers Black Box Warnings - - BioPharm International

ADVERTISEMENT

Europe Considers Black Box Warnings



The European Commission (EC) is seeking to introduce a black symbol to identify medicines that are subject to additional monitoring. A public consultation has been launched for stakeholders to comment on the phasing-in of requirements for such a symbol. The black symbol would be placed in the product information along with the statement: “This medicinal product is subject to additional monitoring”.

Among other points, the EC is interested in hearing about the practicalities of adapting existing product information to the new requirements, particularly the time needed for companies to make the necessary amends. The symbol will need to be applied to all currently marketed products that fall within the scope of the additional monitoring requirements. As such, companies will have to adapt their packaging leaflets, which will be subject to a regulatory procedure by means of a variation.

Additional monitoring is an important part of Europe’s new pharmacovigilance legislation and the symbol will be an important communication and awareness-rising tool. The EC wants to make healthcare professionals and patients aware of products that are subject to additional monitoring to initiate more targeted supervision of such products and to encourage the reporting of any specific, related observations.

All comments must be received by Jan. 10, 2013.

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

EMA Warns of Falsified Herceptin Vials
April 16, 2014
Mallinckrodt to Acquire Questcor Pharmaceuticals
April 16, 2014
American CryoStem and Rutgers University File Joint Patent on Stem Cell Platform
April 11, 2014
Center for Biologics Evaluation and Research Relocates
April 11, 2014
PhRMA Report Reveals Growth Trajectories and Policy Factors Affecting Biopharmaceutical Growth
April 11, 2014
Author Guidelines

Click here