EC opens consultation on "black symbol" for medicines under added monitoring; backs Swiss production standards

The European Commission said last week that it has launched a public consultation on phasing-in requirements on a “black symbol” identifying medicines that are subject to additional monitoring.

The concept of additional monitoring was introduced by the new European Union pharmacovigilance legislation, which started to apply in July this year. Medicines under additional monitoring will be identified with a black symbol in the product information, including the package leaflet inside every pack of the medicine. For these medicines, enhanced data collection is needed to ensure that any new safety hazards are identified as promptly as possible and that appropriate action can be initiated immediately.

The Commission, which needs to select a black symbol by July 2013, is currently considering the need for phasing-in arrangements. The Commission released its consultation paper on its proposed phasing-in arrangements on November 21, with a view to receiving feedback from citizens and public and private organizations. The consultation period is open until January 10, 2013.