Decommissioning Under the FMD/EUDR

iStock_83566139_smallerIt is a little surprising that the European Union Delegated Regulation (EUDR) uses a form of the word “decommission” 67 times, but not even once uses the opposite term, “commission”.  Article 3.2(c) of the EUDR defines the term ‘decommissioning of a unique identifier’ as:

“… the operation changing the active status of a unique identifier stored in the repositories system referred to in Article 31 of this Regulation to a status impeding any further successful verification of the authenticity of that unique identifier;”

It is a striking omission to define how to change the active status of a drug to impede successful verification, but to fail to define the opposite operation that sets the active status to enable successful verification in the first place.  Logical symmetry implies that opposite operation should be called “commissioning” the unique identifier.  Logically you cannot decommission a unique identifier if it wasn’t commissioned in the first place, but the EUDR leaves that to our imaginations.

The GS1 Electronic Product Code Information Services (EPCIS) standard includes these symmetrical operations (actually these are defined in the companion standard, GS1’s Core Business Vocabulary, or CBV, standard).  EPCIS/CBV also contain the concept of “Active” and “Inactive”, making it an obvious choice for implementing solutions targeting the EU Falsified Medicines Directive (FMD).

But drug manufacturers and others need to be aware of potential confusion that can occur when meeting the FMD/EUDR with EPCIS/CBV.  “Decommissioning” in the FMD/EUDR sense does not always equal “decommissioning” in the GS1 EPCIS/CBV sense.  Let me explain.

Any entity in the EU pharma supply chain who exports a drug to a country outside of the European Union is expected to “decommission” the unique identifiers on those packages [see EUDR Article 12(a) and “More Concerns With The FMD/EUDR Big Bang Start”].  But that “decommission” requirement is only for the EUDR system of repositories (see EUDR Chapter VII).  The exporter will rightfully decommission the unique identifiers of the drugs they export within the European Medicines Verification Organization (EMVO) system of repositories.  However, the manufacturers of those drugs will not want to decommission these same unique identifiers within their corporate EPCIS repository, just because a downstream owner of those drugs decided to export them from the territory of the European Union.

To the drug manufacturer, these unique identifiers are still valid, and the authenticity of those drugs and their unique identifiers must still be maintained within their own repository in case they should become entangled in an investigation within the importing market.  That is, the interest of the drug manufacturer is in the ability to verify the authenticity of the unique identifier until it is consumed or destroyed, not just until it is moved from one market to another.

And there are other things that can happen to a given unit of a drug that will lead to a similar discrepancy between what must be done within the EMVO repositories, and what the manufacturer will want to do within their enterprise repository.  The following table results from this:

Unique Identifier Action EUDR System of Repositories Manufacturer’s Repository
Initial packaging: Create record of unique identifier Commission unique identifier
Dispense: Decommission Decommission
Destroy: Decommission Decommission
Repackage: Decommission original UI Decommission original UI
Expired: Decommission *
Stolen: Decommission *
Withdrawn: Decommission *
Recalled: Decommission *
Supplied as free sample: Decommission *
Exported from the EU market: Decommission *

Each asterisk in the table above indicates that the manufacturer may want to show something different in their EPCIS repository than just a “decommission”.  The difference comes from the fact that EPCIS can be much more granular in its application.  As long as a drug package still exists somewhere in the supply chain—whether legitimately or illegitimately—the drug manufacturer will want to keep a record of its unique identifier and only adjust the state attached to that identifier, rather than simply decommission it.  In fact, the unique identifier in the manufacturer’s EPCIS should only be decommissioned when it is known that the drug itself, and/or its manufacturer-generated unique identifier, no longer exists.  That will occur only when the drug is consumed, destroyed or repackaged.  (Whether or not the EUDR or the EMVO will allow the original manufacturer to be notified when any of these events occur is not clear.)

When you look at it this way, it is almost unfortunate that the authors of the EUDR chose to use the term “decommission” in the regulation.  Don’t let it confuse you.


One thought on “Decommissioning Under the FMD/EUDR”

  1. Dirk, it is odd that Commissioning is not mentioned, yet Decommisioning is. Further, as we know from experience, decommissioning is a pretty dramatic step in that (at least with GS1 Standards) it means that the GTIN/serial # combination is dead and its use is over. In the use cases we have seen, there are a number of disposition or status that an item could have that would make it “suspect”. An example would be “dispensed” where the item is part of a shipping event. Unless the item is being shipped internally or between healthcare providers (even that would be inaccurate), an item that has already been marked as “dispensed” probably shouldn’t be observed in a forward logistics move. A reverse logistics move may be valid though. Decommisioning was originally seen as a way of ending the tracking or tracing of an item, as it turns out, there are many disposition/event combinations that are dependent on the type of item and the regulatory or business rules of an industry that determine whether the items should still be in play.

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