‘In accordance with its general obligation of co-operation pursuant to article 111 of Council Directive 2001/83/EC, the Medicines and Healthcare Products Regulatory Agency was lawfully entitled and obliged to supply the European Medicines Agency, pursuant to formal requests under article 8 of Commission Regulation (EC) No 658/2007, with information it had obtained from a marketing authorisation holder.’
WLR Daily, 21st December 2015
Source: www.iclr.co.uk
