The European Commission has launched a public consultationExternal link icon 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 European 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 Wednesday 21 November, with a view to receiving feedback from citizens and public and private organisations. The consultation period is open until 10 January 2013.
For further information, please download:
Commission decision on a 'black symbol' identifying medicinal products for human use that are subject to additional monitoring: Targeted public consultation on phasing-in requirements