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Preparing for the safety features Delegated Regulation under the Falsified Medicines Directive

17 January 2019

On 9 February 2019 the ‘safety features’ Delegated Regulation under the EU Falsified Medicines Directive comes into force. All health and care providers, including registered pharmacies, are expected to meet the requirements within this new legislation.

The Medicines and Healthcare products Regulatory Agency (MHRA) has put together the following information to remind you of the requirements as you prepare for implementation on 9 February. The article also explains how the GPhC and MHRA will work together once the new requirements come into force. 

About the directive

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 for patients and the public to use and that trade in medicines is properly controlled. 

The safety features 

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

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.

Pharmacies will be required to authenticate products, which means visually checking the anti-tamper device and performing a verification and decommissioning scan, “at the time of supplying it to the public”. This process must have been completed at the point the medicine is released to the patient or their representative.

Make sure you are ready for implementation

What you should do now

  1. Understand your own process - Understand and map your own business process to consider where verification and decommissioning fits best and has the least impact on your own business processes.

  2. Speak to system suppliers - It is important to speak with your current software solutions provider to evaluate their readiness for FMD. It is your responsibility to be compliant and if your system supplier will not have a solution in place before February, we recommend looking at alternative solutions. 

  3. Register with SecurMed - SecurMed UK registration is now open. SecurMed will manage the process via a web-facing registration page accommodating registration for single locations and a bulk registration process for organisations registering multiple locations.

From 9 February 2019

  1. Verify and decommission - Begin to scan FMD compliant medicine. In the unusual event that you encounter issues with scanning, there is a manual process to verify and decommission.

The role of the regulators

The General Pharmaceutical Council (GPhC) and the Medicines and Healthcare products Regulatory Agency (MHRA) are working together to make sure the new requirements are met and medicines are safe for the public.

As the regulator for registered pharmacies in Great Britain, the GPhC will use its existing inspection processes to assess whether pharmacies are meeting its standards. For those registered pharmacies that are found not to have met the standards for registered pharmacies, and where a contributing factor relates to breaches of the new safety feature provisions, the GPhC will use its regulatory powers, including improvement action plans, to make sure that pharmacies take action to meet the standards and requirements under legislation.

The MHRA is responsible for making decisions on and instigating any enforcement action in relation to the safety features legislation, which may include seeking compliance, enforcement notices or, as a last resort, criminal prosecution for the most serious, persistent breaches. 

The GPhC and the MHRA will share information, as appropriate, to ensure that the purpose of the legislation is met and that medicines supplied from registered pharmacies are safe for the public to use. 

In the event the UK leaves the EU without a Deal, the Government has recently published information regarding the impact on the new FMD safety features requirements.

Further information and support