EU New'blacksymbol' requirement for drugs could be phased in

摘要

The European Commission is looking at whether phasing-in arrangements will be needed for the black symbol to be included on all medicines subject to additional monitoring to give companies enough time to make the necessary changes to their product labelling.Under the EU pharmacovigilance legislation, a list of all products that are subject to additional monitoring - and will have to carry the symbol - is to be drawn up by the European Medicines Agency.The list will include all medicinal products containing a new active substance, and all new biological medicines, as well as specific products subject to post-authorisation safety commitments or restrictions2.