UK – Implementing the Falsified Medicines Directive: Safety Features

How to prepare for implementation and compliance of the Safety Features Regulation.

The EU Falsified Medicines Directive (2011/62/EU) (FMD) was adopted in 2011 and introduced new harmonised measures to ensure that medicines in the European Union (EU) are safe and that trade in medicines is properly controlled.

The final part of the Directive, the ‘safety features’ Delegated Regulation (EU) 2016/161) comes into force on 9 February 2019.

The European Commission has produced a video to explain more about the safety features.

These safety features are:

  • a unique identifier (a 2D data matrix code and human readable information) which will be placed on medical products that can be scanned at fixed points along the supply chain
  • tamper evident features (anti-tampering devices) on the pack

The unique identifier comprises:

  • a product code which allows the identification of at least the name of the medicine, the common name, the pharmaceutical form, the strength, the pack size, and the pack type
  • a serial number which is a numeric or alphanumeric sequence of a maximum of 20 characters randomly generated
  • a batch number
  • an expiry date who If the member state to which the medicine is being supplied requires it, the unique identifier will also need to include the national reimbursement number (note that this is not applicable in the UK). The unique identifier must be printed on the pack in a 2D data-matrix code and be printed in a way in which the information can be read by the human eye.

The Delegated Regulation does not specify which tamper-evident feature should be used.