The EU falsified medicines directive: an introduction

The falsified medicines directive

IN response to the alarming increase in sub-standard or counterfeit medications, the European Union adopted the Falsified Medicines Directive (FMD) or regulation (EU) 2016/161 on October 2, 2015, which was subsequently published on February 9, 2016.

Understanding the FMD is not an easy task, but this law will become increasingly important throughout the healthcare industry in the coming year.

This legislation states that by February 9, 2019, European hospitals and retail pharmacies will be required to verify and decommission all prescription medications using their unique identifier 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 with guidance as well as practical ready-to-use solutions to help you achieve compliance and much more.

The FMD: how it works

To implement the EU FMD, data will be exchanged between the European Medication Verification System (EMVS), also known as the European Hub, and the National Medication Verification Systems (NMVS), developed by each country within the European Union. The EMVS will receive a Unique Identifier (UI) number from the manufacturer for each prescription medicine to be sold in Europe and act as a “router” to distribute them to the proper NMVS.

Each country’s NMVS database will contain the UIs of all medication currently active in that given country. The unique identifier consists of the medication’s batch number, expiry date, product code, serial number and national reimbursement identification if an individual country requires it. It is important to note that if the reimbursement identification number is contained in the product code, this information does not have to be repeated within the unique identifier. Building upon Directive 2011/62/EU, prescription medication is also required to have a tamper-evident seal, which, if altered, must not be dispensed to the patient.

As of February 9, 2019, pharmaceutical manufacturers will be required to upload their prescription medication’s unique identifiers to the EU HUB (EMVS), where they will then be activated. The medication then leaves the manufacturer and moves through the supply chain, including potential distributors, if applicable, before arriving to hospital and retail pharmacies. Once in possession of the pharmacy, the medication must be verified and decommissioned by its unique identifier. The verification process can take place at any point throughout the healthcare supply chain; however, decommissioning must be performed before the medication is administered to the patient.

Key facts

Authorized persons can revert the decommissioned status of a unique identifier as long as it’s done at the same location where it was initially performed, the medication has not expired or is registered in the national repository system as recalled, withdrawn, intended to be destructed or stolen and is done within 10 days from when the decommissioning was first performed.

Healthcare institutions have the liberty to decide where the verification and decommissioning will be performed while the medication is in their physical possession if no transaction has taken place between the time it was delivered to the pharmacy and administered to the patient.

Decommissioning: Changing the status of a medication’s unique identifier stored in a country’s national repository system (NMVS) from active to inactive.

Unique Identifier (UI): The safety feature enabling the verification of the authenticity and the identification of an individual pack of a medicinal product.

It is the responsibility of a person who is authorized to administer medication to the public to inform the authorities and ensure medication is not delivered to patients if they have reason to believe the packaging of a prescription medication has been tampered with and/or it is not an authentic product due to the verification of its unique identifiers.

The verification of safety features is required by people authorised to administer medication to the public. This includes verification of the authenticity of the unique identifier and the integrity of the tamper-evidence seal. The process is performed by checking the individual identifier against those stored in the national repository system.

The EU FMD applies to any healthcare institution, which is defined as a hospital, in-or-outpatient clinic or health centre.

‘’The inclusion of the product code, the national reimbursement and identification number, the batch number and expiry date in the unique identifier contributes to patient safety by facilitating recall, withdrawal and return procedures and pharmacovigilance in this sector.’’