The 2D matrix code in support of the Falsified Medicines Directive – is your pharmaceutical manufacturing/wholesaling business ready?

In an effort to make the distribution and sale of pharmaceuticals safer than ever before, security features will become mandatory on the packaging of all prescription drugs in February 2019.  (Falsification of medicine is a serious threat to consumers and not just because close replicas can be inconsistent and unreliable, but some may result in adverse effects and perhaps even prove to be life-threatening.)  The technical and organisational details regarding the security features were published together with the Delegated Regulation (EU) 2016/161 on February 9^th, 2016.

To minimise the risk of tampering, pharmaceutical packaging will carry tamper-evident features of which the choice of technical specification is left to the manufacturers, just as long as it’s sufficiently suitable to deter all forms of tampering.

The other security feature will allow for the identification and verification of the authenticity of a medicine and will be in the form of a 2D matrix code on each pack and which can be ‘read’ by common scanners.  The 2D matrix code is used to check against an entry in an official repositories system during the distribution process with the whole system involving verification, decommissioning or recommissioning of serialised packs with the aim being to eliminate the risk of a falsified medicine entering the supply chain.

With February 2019 getting closer, the European GDP association conducted a survey in which over 100 companies across Europe responded.  Almost half of the respondents were from pharmaceutical manufacturers whilst 30% were wholesalers (the remainder were distribution service providers and transport companies).

It is quite clear, and concerning, that almost 30% of respondents are under the impression that the requirements are not relevant to them.

For those in a quality/regulatory function within a pharmaceutical manufacturing/wholesaling business with no plans to accommodate and utilise the 2D matrix code, perhaps it’s time to revisit the Commission Delegated Regulation (EU) 2016/161 and check your business’ state of readiness for when the new medicine verification systems take effect from February 9th 2019.

Link to Commission Delegated Regulation (EU) 2016/161: