The European Commission published a discussion draft of the European Union Delegated Act (EUDA) about two weeks ago (See “Breaking News: The EC Has Published The Delegated Act“). The EUDA was called for in the Falsified Medicines Directive (FMD) back in 2011 and is primarily intended to define the “safety features” that must appear on most drugs three years after it is finalized. Assuming it gets finalized around the end of 2015, that means that manufacturers and repackagers targeting the European pharmaceutical market will need to begin placing the specified safety features on their drug packages near the end of 2018. EU Member States who already have an operational drug tracing law, like Italy and a few others, get an additional six years for companies to switch to the FMD and EUDA on drugs distributed there.
There are a lot of details about the operation of the drug tracing solution in the EUDA document. I hope to cover different parts of it over several RxTrace essays. Be aware that we are referring to a discussion draft, not the final version, so some things could change between now and then. I suspect that the kind of things that will change are going to be minor so I feel comfortable discussing the larger topics. However, if anything I write does end up changing, I will make the change retroactively in that essay and I will also write a new essay about the change since it would probably be significant.
This essay is about the “unique identifier”, which is one of two safety features that the EUDA mandates. According to the text, a “unique identifier” is a code consisting of:
- The product code
This is “a code allowing the identification of at least the name, the common name, the pharmaceutical form, the strength, the package size and the package type of the medicinal product bearing the unique identifier.” The EUDA does not say anything about GS1, but it appears clear that a GS1 Global Trade Item Number (GTIN) will be accepted as a valid product code, although it also appears that it is not the only code that will be accepted. The choice of identifier used in the product code field is not up to you or me. It is up to the local regulator in each EU Member State. This variation will add significant complexity to compliance (see “The FMD Product Code“).
- A serial number
This is “a numeric or alphanumeric sequence of maximum 20 characters, generated by a deterministic or a non-deterministic randomization algorithm.” The definition appears to conform to GS1’s serial number that is associated with a GTIN. The randomization requirement goes beyond GS1’s specification but does not cause any conflict with it. Adding some clarification to the randomization requirement, the text says that “The probability that the serial number can be guessed shall be negligible and in any case lower than one in ten thousand.” (For more on randomization of GS1 serial numbers, see the five-part series starting with “Randomization—An Interview with Ken Traub—Part 1: GS1 Serial Number Considerations”.);
- A national reimbursement number
This is any number that an EU Member State where the product is intended to be placed on the market may require. So far only a handful of Member States have their own national reimbursement numbers. For drugs marketed in Member States that do not have their own, this data element will not be present. Also, “Where the national reimbursement number or other national number identifying the medicinal product is contained in the product code, it is not required to be repeated within the unique identifier.”;
- The batch number
This is sometimes referred to elsewhere as the “Lot Number”;
- The expiry date.
Oddly, the EUDA does not require the batch number or the expiry date to appear on packages in human readable form. If this is really true then it is one way to get around the problem of formatting the date in a standard way (for more on human readable date formatting, see “What The UDI Date Format Says About FDA’s Direction”). According to the EUDA, only the product code, serial number and national reimbursement number must appear in human readable form, subject to the size of the package.
For the machine readable form, this unique identifier must be encoded in a Data Matrix ECC200 barcode. The EUDA specifically allows companies to encode additional data within this same barcode, where permitted. And importantly, the regulation does not allow “…any other visible two-dimensional barcode [except] the two-dimensional barcode carrying the unique identifier for the purpose of their identification and verification of their authenticity.”
The second safety feature that must be on all drug packages is an anti-tampering device. No additional details are provided about these devices in the text.
Stay tuned for more on the EUDA in future essays.