Under the Falsified Medicines Directive (FMD), starting on February 9, 2019 drug manufacturers must begin affixing a new Unique Identifier and an anti-tamper device to all consumer packages of prescription drugs (see “The E.C. Officially Published The Pharma Safety Feature Delegated Act This Morning”). The Unique Identifier must be composed of a Product Code, Serial Number, Batch Number, Expiration Date and, where required, a National Reimbursement Code (see “The ‘Unique Identifier’ in the EU Delegated Act”). This data must be uploaded to the E.U. Hub prior to shipment into the supply chain. All of the details are spelled out in the Delegated Regulation (EUDR).
One of the more interesting aspects of the FMD/EUDR is the Product Code. It’s interesting because it can get convoluted. The EUDR defines the Product Code as:
“a code allowing the identification of at least the name, the common name, the pharmaceutical form, the strength, the pack size and the pack type of the medicinal product bearing the unique identifier”
In every other market, the Product Code equivalent is a fixed identifier. For example, in the United States, under the Drug Supply Chan Security Act (DSCSA), the National Drug Code (NDC) serves as the Product Code (see “Anatomy Of The National Drug Code”, “Depicting An NDC Within A GTIN” and “NDC Nearing Its End, Afflicted by ‘Identifier Failure’”). But under the EUDR, each EU Member State gets to define their own. How can this work?
Fortunately, the member states have each aligned behind one of four different approaches. I say “fortunately”, only because we could have ended up with no alignment and 30 different approaches. These “fortunate” four approaches are:
- A GS1 Global Trade Item Number (GTIN)
This is the global standard product identifier. GS1 defines it this way: “The GS1 Identification Key used to identify trade items. The key comprises a GS1 Company Prefix, an Item Reference and Check Digit”.
- A National Trade Item Number (NTIN)
GS1 defines it this way: “A coding scheme, administered in the Healthcare sector by a national organisation for which a GS1 Prefix has been issued to permit its uniqueness within the GTIN pool but without assurance of full compatibility with GTIN functionality. The result is a product identification number assigned by a third party (not the brand owner or manufacturer). Example: the CIP (Club Inter Pharmaceutique) in France administered by the French Health Products Safety Agency (AFSSAPS).”
- Either a GTIN or an NTIN
These Member States will allow you to choose either of these two identifiers for your Product Codes.
- A National Healthcare Reimbursement Number (NHRN)
GS1 defines it this way: “National and/or regional identification numbers used on pharmaceutical and/or medical devices where required by national or regional regulatory organisations for product registration purposes and/or for the management of Healthcare provider reimbursement”.
Some Member States will require the FMD Unique Identifier to include a NHRN in the National Reimbursement Code field in addition to the Product Code (see also “Product Identification And National Registration Codes”). Pharma manufacturers who distribute drugs across the entire European Union will need to be very careful about using the right kind of Product Identifier and Reimbursement Code (where required) for each Member State.
Which States accept which approach? GS1 Healthcare has compiled a very nice list for you and they update it occasionally because things are still changing (which is another problem for drug manufacturers). Sadly, GS1 doesn’t post it on a fixed URL where you can see it just by clicking on it, but instead, they bury it in PowerPoint presentations. Here is the link to one of the recent PPT files. Click on the link and scroll down to slide 18. This information is very fresh (relative to the posting date of this essay). That PPT file contains valuable information about transitioning from current identifiers to those that will be necessary to meet the FMD in 2019 (see also “Recommendations on a harmonised implementation of the EU Falsified Medicines Directive using GS1 standards”).
Another semi-valuable document from GS1 Healthcare is called “Discussion paper on multi-market packs for pharmaceutical products”. This document is intended to “…help demonstrate ways in which GS1 bar codes can be used to minimise the need for multiple bar codes to appear on product packaging while still enabling products to be supplied to multiple countries.” This is the document from which I took the definitions above.
But be very careful when using this document because it pre-dates the Delegated Regulation. For that reason, it is incomplete and could lead you astray in some scenarios. Hopefully GS1 Healthcare will update this document to clearly reflect the current and future FMD requirements. The best use of this document right now is to provide background on the issue of different Product Code requirements in the EU and how you might deal with the different approaches listed above, using GS1 standards.
NTIN AS PRODUCT CODE
Use of an NTIN as the Product Code is problematic for packs that are distributed in multiple Member States because they are carved out of the same pool of identifiers as GTINs. Just like it is senseless (and a violation of GS1 standards) to include two GTINs on the same package, it is also senseless to include a GTIN and an NTIN on the same package.
To encode a GTIN into a GS1 barcode you use Application Identifier (AI) (01). According to the GS1 General Specifications, any given trade item may have only one GTIN assigned to it, and any GS1 barcode that allows AIs may only contain a single instance of AI (01) (see also “Healthcare GTIN Allocation Rules”). When a barcode contains an NTIN, it also uses AI (01) to encode it. Since you can’t have more than one AI (01) in the barcode on the package, that package cannot (shall not) have both a GTIN and an NTIN assigned to it. Nor can it have more than one NTIN assigned to it. But because NTINs are national (that’s what the “N” stands for), packages sold into multiple Member States that require an NTIN would require more than one NTIN in the barcode, which we just demonstrated does not work.
WHEN INCLUDING A NATIONAL REIMBURSEMENT NUMBER
Some Member States require a National Reimbursement Number in addition to the Product Code. To encode an NHRN into a GS1 barcode you must encode it using the specific AI assigned by GS1 for the specific target country. When doing that, the General Specifications require the barcode to also have a GTIN encoded in it—using AI (01), of course. Because NTINs are not GTINs (despite how they may look) you cannot encode an NTIN along with an NHRN in the same barcode. So, to meet the requirements of Member States that require a National Reimbursement Code, you must assign a GTIN, and not an NTIN, as the Product Code. GS1 recently conducted an internal evaluation which confirmed this conclusion.
Member States that require the use of their own existing national codes today for a Product Code (Italy and Portugal, according to GS1 Healthcare) will need to switch to something else before February of 2019 because the Delegated Regulation requires the Product Code to be globally unique and/or meet ISO/IEC 15459-3:2014 and ISO/IEC 15459-4:2014. Those standards effectively result in identifiers that are globally unique. The EUDR provides Italy with an extra six years to conform so they have plenty of time to move away from their Bollino Code, but Portugal will need to figure it out very soon. I understand they are working on it aggressively right now.
As you can see, drug manufacturers need to carefully develop a strategy for meeting all of these local Product Code requirements well before 2019 because how they meet them will affect their packaging and distribution strategies going forward.
RESOURCES, RESOURCES, RESOURCES
I can recommend several resources to those facing the FMD. These include:
- The Pharmaceutical Traceability Forum | Interactive conference (located in Washington DC on December 7-8, right after the next FDA DSCSA Public Meeting) will have speakers who are experts on the FMD and the EUDR;
- I have curated a nice list of FMD resources that is available here;
- I am conducting a webinar in just a few days that focuses on the FMD. You can register (or listen to the recording) here.