Falsified Medicines Directive Compliance: A Quick Overview of Requirements for Wholesalers, Distributors and Logistics Partners

Each passing day brings the pharmaceutical industry closer to the inevitable deadline of February 9, 2019 and the enforcement of serialization, track and trace and reporting requirements imposed by the European Falsified Medicines Directive (FMD) 2011/62/EU to many stakeholders at different levels of the pharmaceutical supply chain.

At the beginning of the pharmaceutical supply chain, Marketing Authorization Holders (MAHs) must serialize cartons (Unique Identifier), use tamper-evident devices and then report the data of serialized batches to the European Medicines Verification System (EMVS), also called “the European Hub”.

At the very end of the supply chain, dispensers (pharmacies and hospitals) must verify and decommission every sold unit against the National Medicines Verification System (NMVS) of the country where the product is sold.

Yet, what does the EU FMD require from stakeholders in the middle of the pharma supply chain such as wholesalers, distributors and other logistics partners? If you are still asking yourself this question, it is definitely time to take action!

While we are on the subject of actions, there are actually two scenarios that every pharmaceutical wholesaler and distributor in the EU market should prepare for: verifying and decommissioning prescription drug saleable units. Let’s dig into the details of the delegated regulation.

Medicine Verification for Wholesalers and Distributors: When does it Apply?

On one hand, according to the EU FMD, wholesalers and distributors must be able to ensure the verification of a single pack or a bulk of prescription drug packs in the following cases:

• Risk-based verification: a wholesaler/distributor buying products off the market or from another wholesaler/distributor
• Saleable returns: a wholesaler/distributor must verify serial number of returned products before reselling them

Source: EMVO

Decommissioning Medicinal Products: A Wide Range of Cases

On the other hand, wholesalers and distributors must be able to perform decommissioning to remove prescription medicine units from the market when one of the following cases occurs:

• Stolen: stolen product packs to be reported
• Checked-Out: proxy for Repacked
• Free Sample: provided as free samples
• Sample (NCA): provided as samples to the National Competent Authorities
• Intended for destruction: product packs to be destroyed
• Locked: a product pack is locked temporarily for investigation purposes
• Supplied: proxy for Dispensed
• Export pack from EU: setting the indication of product packs to “exported from EU” following an export from the EU

Article 23: Impact on Wholesalers and Distributors

“Article 23” (precisely Chapter V, Article 23 of the Delegated Regulation) gives the flexibility to a EU Member State to require that the verification and decommissioning of pharmaceutical products can be performed by wholesalers and distributors on behalf of persons or institutions other than a dispensing hospital or pharmacy (it can be for instance prisons, universities or dental practitioners). As far as  Article 23 represents one key area of flexibility for member states to change set specific rules in one country, wholesalers and distributors operating at an international level should prepare for differing situations between countries and keep an eye on the details.

Practically speaking, what does the EU FMD requirement for supply chain partners entail?

Fortunately for wholesalers and distributors, the impact of the requirements from the European regulation should cause much less stress when compared to drug manufacturers, both in terms of level of investment and complexity of implementation. Key steps to secure:

1. Ensure capability to scan 2D data matrix barcodes printed on drug packs, either using mobile hand held devices (even mobile phones), desktop scanners or automated imaging technology
2. Choose a software application that provides a secure connection to the National Medicines Verification System (NMVS) and enables the scanned item (and its serialization data) to be verified instantaneously against data held on the National Hub.

With a looming deadline, it’s now time for wholesalers, distributors and other logistics partners to get up to speed and get ready to manage the impact of EU FMD within their operations. It results in understanding which scenario they will have to deal with, fostering the implementation and adoption of medicine verification and decommissioning systems at their facilities to ensure compliance on the approaching D-Day of February 2019.