8 steps to prepare your pharmacy for medicine authentication and EU FMD

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8 steps to prepare your pharmacy for medicine authentication and EU FMD

Although the European Union’s Falsified Medicines Directive (EU FMD) comes into effect on 9 February 2019 and has been well publicised, many pharmacies have yet to formulate their plans for compliance.

Conversations with retail and hospital pharmacists tend to follow a similar vein. There is an expectation that their requirement to comply will somehow be postponed, so there’s no need to hurry to identify a suitable solution. That’s not going to happen. As the recent letter sent by the EU’s tripartite medical agencies very clearly states, “all stakeholders need to act now to ensure compliance with the new rules whilst there is still sufficient time to prepare.”

Mandatory verification and decommissioning of prescription medications will come into force as planned because of the danger presented by the underlying problem: a need to protect patients from the ever-increasing danger of falsified medicines. The World Health Organization (WHO) estimates that 10% of medicines in global circulation are actually fake and a major factor in one million preventable patient deaths every year, particularly in developing countries, and these products typically enter the supply chain from the EU.

The EU FMD is also an important first step towards the digital transformation of pharmacies. Currently, staff in many pharmacies spend a significant amount of their time performing manual tasks that could be automated using much of the technology they will invest in as part of EU FMD compliance. For instance, verifying medication at the goods-in stage completes the first phase of the decommissioning process and eliminates the need for separate inventory management processes.

Rather than having to do manual stock checks, pharmacy staff can operate a perpetual inventory check and avoid out-of-stocks since the moment an inventory item falls below a minimum level, an automatic replenishment can be triggered. As NHS Digital said recently, “Inefficient, paper-based processes increase the potential for errors and cost money, whereas digitising the prescription and distribution of medicines has an enormous potential to improve patient care and increase safety levels.”

How to complete the EU FMD compliance processan 8-step guide for pharmacies

  1. Become familiar with the new EU FMD medicines authentication process, how it will be implemented and your role within it. This includes reviewing pilot studies outlining how software and hardware solutions can be used to support compliance. See how it will work in practice.


  1. Research potential NMVS software providers and establish a contract and service level agreement with them. Many software solutions are available and the easiest to implement are fully cloud hosted.


  1. Formally register with the NMVS online. The first step for registration is to create an account for your Requestor. The Requestor should then specify the following:


  • End User Location, End User Location Contactand a Software Supplier
  • Registration requires the following information:
  • Name of Legal Entity and Address for the End User Location
  • End User Location Function(s)
  • Registration Body for the Location and Registration ID
  • Name, Email and Business Phone for the End User Location Contact
  • Your Software Supplier Name, Software Name and Version.


  1. Connect your EU FMD software solution to your NMVS using the credentials returned from NMVS registration.


  1. Install a scanner or barcode reader and ensure it’s working properly with the software and NMVS interface.


  1. Update pharmacy workflow processes. This is potentially one of the trickier aspects to get right and critical since the EU FMD regulations will inevitably have an impact on workflow. Questions like, “when is the best time to decommission products?” need to be answered. It’s helpful to run a pilot to identify the best point in the pharmacy workflow to scan products to minimise disruption.


  1. Update your SOP. Medicines should be scanned during the dispensing process, which requires the SOP for Dispensing to be amended.


  1. Start scanning. Even though the regulations don’t come into operation until 9 February 2019, our advice is to start scanning products as soon as you have installed a compliance solution.


As the EU’s tripartite medical agencies state, retail pharmacies, hospital pharmacies and healthcare institutions all have a critical role in ensuring the authenticity of medicines dispensed to patients. It is important that all stakeholders act quickly to ensure they comply with the EU FMD regulations while there is still time to prepare.

Optel Group have developed an easy to use, online demonstrator to illustrate to pharmacists how simple the FMD compliance process can be.


Try it out for yourself – all you need is a camera phone.



Korina Fischer, VP of Healthcare at Optel Group




Get compliant with OPTEL

OPTEL Certa™ Software performs barcode verification as well as decommissioning of prescription medication. With its safe and secure communication with the NMVS of countries across the EU, this unique web product provides healthcare professionals with an immediate solution for compliance with the EU FMD.