The Pharmacovigilance Risk Assessment Committee (PRAC) is an EU committee which has been formed since implementation of the new Pharmacovigilance (PhV) regulations and they have the responsibility for determining which products will be under intensive surveillance and what the intensive monitoring symbol will be.
The list of products under intensive surveillance is due to be published in October 2012. The products on the list must carry the black intensive monitoring symbol by 2nd July 2013. The shape of the symbol hasn’t yet been confirmed.
The MHRA has confirmed that companies need to continue using the Black Triangle on the relevant products in the meantime and that they will contact companies with Black Triangle products, in due course, with guidance on how to move to the new intensive monitoring symbol and regulations.