FMD safety feature consultation response

Warwick Smith, Director General of the British Generic Manufacturers Association (BGMA) and the British Biosimilars Association (BBA), said: “In order to support effective implementation of the Falsified Medicines Directive (FMD), the enforcement regime needs to be timely and to have sufficient rigour to help ensure all steps in the medicines supply chain deliver the operating system at the same time, up to and including the point where the patient’s medicine is dispensed.
 
“Our association and members have been very actively involved in the UK implementation of some of the safety features components of FMD, so that those medicines bearing them can be identified and authenticated, as they move through the supply chain.
 
“We believe the implementation of FMD safety features should not lead to changes in the range of medicines distribution routes in UK. 
 
“The Falsified Medicines Directive is for the benefit of public health. Therefore its implementation should be enforced equally at each point of the medicines supply network, up to the point at which the individual patient receives their medicine.”