FDA draft announcement to delay DSCSA Product Identifier by one year. But don’t breath a sigh of relief just yet…

Wikimedia Foundation [CC BY 2.0 (http://creativecommons.org/licenses/by/2.0) or CC BY-SA 3.0 (http://creativecommons.org/licenses/by-sa/3.0)], via Wikimedia Commons

“I love deadlines. I love the whooshing noise they make as they go by…” is a quote frequently attributed to Douglas Adams, author of The Hitchhiker’s Guide to the Galaxy.

There has been an echo of this sentiment along with comments similar to “Were those early fireworks heard going off out there in the pharma world!?” as the news of FDA’s draft announcement to delay the enforcement of DSCSA Product Identifier implementation by one year – from November 2017 to November 2018 – began to spread.

Is this the beginning of a move in the timeline for the USA, a market where there are critical concerns about industry readiness to apply the Standardized Numerical Identifier (SNI) by November of this year?

And could this be the indication that we will see a similar move in Europe where, again, industry readiness for the EU-FMD deadline of February 2019 is a major concern?

Alas, lighting any fireworks for other purposes than Independence Day celebrations in the US is not advised at this time.

The FDA announcement is a draft proposal only. It affects only one part of legislation.

Just to be clear what the FDA announcement is and is not: It is a draft proposal only, at this stage (though it is widely anticipated that the proposal will stand) and only affects the date of enforcement of one aspect of the law, the obligation on pharmaceutical manufacturers to apply a unique identifier. The law still goes into effect 11/2017, but the FDA has just stated they will not enforce the Law until 11/2018.

The FDA announcement also does not touch on the related but separate deadlines affecting repackagers, wholesale distributors and dispensers (nor the obligations on these trading partners regarding saleable returns). Also worth noting is that there is no suggestion that the enforcement delay will also apply to the requirement to provide the Electronic T3 Lot Trace solution by 11/2017 (paper is no longer valid as of that date).

So any indication that this is the beginning of a broader shift to the deadlines in the US appears to be seriously misguided.

What about in Europe? Can we expect the same?

In regards to Europe: There are absolutely no indications of any postponement. The Directive and Delegated Regulation are very clear about the date set out in Article 50 of the DR: “This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 9 February 2019.”

Neither the Q&A published on the European Commission Website (https://ec.europa.eu/health/human-use/falsified_medicines_en) nor any public utterances give any support to the assumption that any change of compliance date is being considered. After all, the argument may well go: The overall requirement and much detail regarding the obligations on pharmaceutical manufacturers has been public knowledge at least since 8^th June 2011 when the original Directive was issued, so the excuse that there has been no visibility of these requirements will simply not wash.

The message to industry must remain crystal clear: Continue with high urgency your preparation for compliance with DSCSA and EU-FMD, in particular:

1. Ensure the capability in-house (and in your external CMO network) to apply Unique Identifiers (UIs)/ Standardized Numerical Identifier (SNIs) (and in Europe the Anti-Tampering device) to every pack
2. Establish your repository that allows you to manage this critical business data in a secure, reliable and timely manner
3. For Europe, on-board your company to the European System by completing the mandatory EMVO on-boarding process.

Time to love deadlines and be on time for serialization compliance

Remember, 3C Excellis Europe can help you with all these steps through our Products and Services:

• CMO on-boarding service
• Serialisation: secured. Our actionable intelligence will support your readiness programme from inception to successful delivery
• EU-Hub on-boarding service: Secure and streamline your EU-hub on-boarding with 3C Excellis. 3C Excellis has a structured, centralized on-boarding process for the EUFMD to make sure we are efficient with your time and you can benefit from a successful secured on-boarding to the EU-Hub. 3C Excellis managed on-boarding: simple and secure – We help you make sure that you get your application right, first time, for a speedy and painless on-boarding to the European Hub

We’ll have more details on our website, Twitter and LinkedIn shortly or email getsecured@3CExcellis.eu for more information.