a pharmacist at computer imageJuly 20 2018

A consultation asking for views on how the safety features required under the Falsified Medicines Directive should be implemented has been issued.


The MHRA has launched the consultation with the FMD due to come into force from February 9 2019. The Directive requires all medicines to incorporate “safety features” which will involve:

  • a unique identifier (a 2D data matrix code and human readable information) that must be scanned at fixed points along the supply chain, including at the point of dispensing;
  • an anti-tampering device allowing verification of whether the packaging of a medicinal product has been tampered with.

The consultation papers include a number of questions as well as an impact assessment looking at proposed options for introducing the FMD system and what it might mean in financial and practical terms.

Among the issues where views are sought are:

  • what form of sanctions regime would be the most effective to enforce the regulations across the UK medicines supply chain?
  • is there any additional evidence or comment on the existing impact analysis to develop the cost benefit analysis in the impact assessment?
  • should manufacturers should be allowed to include information other than the unique identifier in the 2D data matrix code?

The consultation runs until September 23 2018.

The Royal Pharmaceutical Society has said it will be responding to this consultation and wants to hear members’ views on it. “If you would like to contribute to our response, please contact Aileen Bryson by 31 August,” it said. An email link is included in its announcement.

Links:
MHRA FMD consultation           
RPS comment