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.