Dr Prashanth BSB, head of safety and medical writing for ELC Group, talks to EPM about the ramifications Brexit may have on the pharmacovigilance landscape.
A changing landscape
The legal framework of pharmacovigilance (PV) for medicines marketed within the EU is provided for in regulation (EC) no 726/20041 with respect to centrally authorised medicinal products, and in directive 2001/83/EC with respect to nationally authorised medicinal products (including those authorised through the mutual recognition and decentralised systems).