EU FMD solutions for dispensers Improving patient safety

Comply Now with the EU FMD

9 February 2019

With our end-to-end traceability solutions, OPTEL is currently helping pharmaceutical manufacturers, wholesalers and dispensers across Europe to ensure compliance with the European Union Falsified Medicines Directive (EU FMD). 

In response to the alarming increase in substandard or counterfeit medications, the European Union adopted the  FMD, or regulation (EU) 2016/161, on 2 October 2015, and subsequently published it on 9 February 2016. This legislation states that, by 9 February 2019, European hospitals and retail pharmacies will be required to decommission prescription medications using unique identifiers before distributing them to patients.

The road to compliance is short and difficult to navigate. As a leading provider of traceability systems since 1989, OPTEL can act as a trustworthy partner, supporting pharmacists and staff with guidance as well as effective, ready-to-use solutions to help you achieve compliance and much more.



100% Compliance: OPTEL CERTA™ SOFTWARE

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

  • EMVS connectivity
  • Verification, decommissioning, recommissioning
  • Reports and dashboards
  • Flexible and easy integration

OPTEL Certa™ Software can integrate into our flexible hardware devices or simply connect to your pharmacy systems.



The 9 February deadline is approaching fast. Get ready.

Where to decommission?

We understand that verification and decommissioning are added steps to your workflow operations. See how our solution can easily integrate into your daily operations.

First step towards compliance

How many packs per day do you dispense? Tell us more about your pharmacy.

What about article 23?

Find answers to your questions.

Solutions for every dispensing institution

Retail pharmacies

Stationary or mobile, our solutions can improve any pharmacy's workflow.

Hospitals and healthcare institutions

Our flexible solutions can adapt to any hospital size.

Vaccination clinics

Vaccination clinics must comply with the EU FMD as well – We have the solutions to help.

Trial clinics

Our tested solutions help trial clinics achieve compliance.

Connect with us


Take a look at the events we have attented, as well as the ones we will attend next. See you soon!


OPTEL GROUP, announce that it is now officially connected to the Irish Medicines Verification Organisation (IMVO), part of the European Medicines Verification System (EMVS).


Let our experts help you understand the particularities of the EU FMD and how you can comply.

Contact Us