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UK MHRA: Implementing the Falsified Medicines Directive: Safety Features

How the Falsified Medicines Directive works

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.

Member States have until 9 February 2019 to implement the final part of the Directive, the ‘safety features’ Delegated Regulation (EU) 2016/161).

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.

The choice of tamper-evident feature to be used will be for the marketing authorisation holder (MAHs) to decide. A European Standard is available which gives guidance on the types of tamper-evident features which could be considered by MAHs. This is titled ‘Tamper verification features for medicinal product packaging EN 16679:2014’.

The Delegated Regulation comes into force in 2019. MAHs will be required to place the safety features on the packaging of medicines which fall within the remit of the Delegated Regulation no later than 9 February 2019.

Manufacturers will place the safety features on the packaging of prescription only medicines and upload the data into the European repository system prior to placing the product on the market. The 2D barcode will need to be scanned at various points in the supply chain to verify that it is an ‘authentic’ medicine.

On supply to the patient, the unique identifier must be ‘decommissioned’ via a scan from the FMD system, to prevent any duplication of a legitimate identifier for use on a falsified medicine. This will be checked against data in the national repository, which in the UK is run by SecurMed UK.

MHRA and the Department for Health and Social Care will continue to publish further guidance to inform all stakeholders throughout the supply chain as it becomes available. To suggest any non-Government guidance for inclusion on this page please email FMD.safetyfeatures@mhra.gov.uk.

Posted on the UK MHRA website on 8 January 2019

2019-01-08T21:12:12+00:0009.01.2019|Regulatory Affairs|