What you need to know about Europe's serialization requirements

September 4, 2022

The Falsified Medicines Directive – the overseas cousin of our Drug Supply Chain Security Act (DSCSA) that protects the European public from counterfeit, stolen, expired, and recalled drugs – became law this past January. It sets in motion a number of requirements for pharmaceutical manufacturers, distributors, and wholesalers doing business in the 28-nation E.U.

It’s an important step: Including the 28 E.U. member countries, there are now 40 countries in the world with active serialization regulations. These 40 countries make up 90 percent of the world’s population, which consumes – not surprisingly – 90 percent of the world’s pharmaceuticals. With the health and safety of so many people at stake, you’d expect there to be strong international standards that serve as a backbone for serialization regulations – but you’d be wrong. For any company doing global pharma business, there are a number of regulatory challenges to consider.

The Differences: U.S. DSCSA vs. E.U. Falsified Medicines Directive

  1. Serial numbers: In the E.U., the Delegated Act requires "a numeric or alphanumeric sequence of maximum 20 characters, generated by a deterministic or a non-deterministic randomization algorithm." In the U.S., the DSCSA requires a "standardized numerical identifier” – a set of numbers or characters that uniquely identify each package or homogenous case, composed of the National Drug Code (NDC). Randomization is not required in the U.S.
  2. Anti-tampering devices: Drugs sold to E.U. member countries must carry a safety feature that can verify whether or not the packaging of a drug product has been tampered with. There is no such anti-tampering device requirement in the DSCSA.
  3. Repositories system: The E.U. is establishing a repositories system that will allow trading partners to upload and update information about the movement of drug products. For instance, data about serialization and safety features will be logged, which will help identify and authenticate drug products. The U.S. does not have any central repositories for serialization.
  4. Unique identifier decommissioning: Decommissioning is an added drug-safety feature that works within the repositories system and allows for the active status of a unique identifier in the repository to be changed to “inactive.” For example, if an expired product is removed from the E.U. supply chain, it will be marked as "decommissioned" in the repositories system. Drug manufacturers doing business in the U.S. DSCSA don’t have this requirement.

There are other differences, too, such as the difficulty of getting global support from key vendors, and the need to run global serialization as a local project with local teams (or local/global hybrid teams). In short, global serialization deployment is a technically difficult and labor intensive undertaking.

The Big Similarity

Time crunch. Serialization implementation schedules are always longer than companies imagine. According to a article looking at the Delegate Act, “Estimates are that making the necessary changes to packaging lines and IT systems to incorporate serialization – and verify that the systems are working properly – can take as long as two years from start to finish.” While larger manufacturers have more resources and bigger budgets that help them overcome some of the time hurdles, smaller and mid-sized companies usually don’t.

Simplify Global Serialization, With LSPediA

We manage global serialization projects for companies of all sizes, simplifying every part of the process – gap analysis, strategy, IT infrastructure, vendor management, line execution, training, and other components. Regardless of which country you operate in, LSPediA ensures your organization can:

  • Lower overall serialization spending by reducing the number of redesigns
  • Mitigate compliance risks and reduce recalls with comprehensive, gapless coverage tailored to your specific needs
  • Shorten your project timeline by removing trial-and-error process

To learn more, contact me today. We’ll discuss how we can create a customized solution that fits your organization’s needs.

About LSPediA

LSPediA helps pharmaceutical manufacturers and distributors implement serialization and aggregation processes to meet global regulations, DSCSA requirements, and future track-and-trace mandates. Our services include URS, RFQ, gap analysis, serialization toolkits and solutions, DSCSA strategies, management consulting, and more.

We value long-term relationships and work with our clients’ internal teams to properly define roadmaps, create architectures, and implement systems that align to vital business goals, ultimately helping them derive maximum value from their investments, both now and well into the future.