THE EU FMD
EU FMD PREPARATION READINESS
Early EU FMD pilots have uncovered the potential implementa-
tion issues in achieving compliance, providing valuable consid-
erations for manufacturers. If you are a manufacturer or MAH
that needs to comply with the EU FMD regulations, consider the
• Consideration 1: Understand program and business require-
ments to determine a plan for serialization. Determine the
current scope of your products and how they are impacted
by the regulations. In addition, gain an understanding of
how products are packaged, i.e. is this done in-house or
outsourced? Will your products be aggregated or not ag-
gregated? What will be the trigger for sending data to the
EU Hub—will it be shipment or product release? Taking a
complete look at internal business processes will provide a
picture of what needs to be accomplished.
• Consideration 2: Understand the requirements and differences market-by-market. Once the full scope of products
and business processes are understood, think about your
requirements in different market regions and how these will
be met. If you may be selling pharmaceutical product into
different markets in the future, determine how this will be
• Consideration 3: Understand best practices and lessons
learned for serialization. If you’ve implemented serialization
strategies for markets with existing legislation such as Turkey and China, consider incorporating best practices from
those programs. If you do not have any prior experience,
speak with other manufacturers, vendors and solution providers that can provide valuable guidance on best practices.
One lesson applies universally to all markets—start earlier
than you think you need to, this will ensure enough time for
any unforeseen challenges that may arise.
• Consideration 4: Understand the questions to ask partners to
determine serialization readiness. Serialization will require
the exchange of information with multiple partners, including regulatory authorities, contract manufacturers, contract
packagers and third party logistics providers (3PLs). Once
you understand your own business requirements, communicate these clearly to all of your trade partners. In turn, ask
your partners about their previous serialization experience,
existing lines for serialization or plans for line upgrades, and
their capabilities for data exchange.
EU COMPLIANCE IMPLEMENTATION ROADMAP
An effective implementation roadmap should ideally follow
1. Select an enterprise software solution. This is the solution
that will enable manufacturers to provide information to
the EU Hub.
2. Map out CMO/CPO/3PL partners and evaluate their integration plans. Companies need to ensure that their partners’
plans fit within their timelines.
3. Determine your serialization and aggregation plans with
line systems. What will this mean in terms of adaptations to
lines and requirements for new equipment?
4. Define inventory management with serialization. Serialized
products will add a new level of complexity to warehouse
management that will need to be managed.
5. Accommodate all country requirements and compliance.
6. Test end-to-end data flows with trade partners. This will in-
volve all partners, the EU Hub, national systems and even
pharmacies at the point of dispense.
7. Plan production runs with required lead times.
Serialization impacts many different groups within the pharmaceutical supply chain and it’s not as simple as just applying a 2D
matrix code to a bottle. Manufacturers will need to coordinate
with many different teams, internally and externally.
Preparing early and creating a plan for serialization will be
fundamental in avoiding delays. The legal deadline to connect
to the EU Hub is February 9, 2019. There is however, a practical
business need to test connections several months beforehand.
SELECTING A SERIALIZATION SOLUTION
The EU market is the largest regional market for medicines in
the world. The complex set of compliance requirements will impact not only a pharmaceutical organization but the entire supply
chain network. It is vital to choose a serialization solution that
can deliver network connectivity, scalability and compliance capabilities that ensure supply.
The ability to connect to a track-and-trace network for the
pharmaceutical supply chain via a single connection has the potential to significantly speed-up and simplify the ability to serialize, report and manage products for compliance. Equally, being
able to take advantage of already established connections to the
EU Hub, as well as gain access to an existing EMVO account,
could significantly shorten compliance timelines.
It is also fundamental to look for a serialization data exchange
solution that is scalable and can handle the billions of serialization numbers generated. When preparing for serialization, flexible solutions will be key—the regulatory landscape is likely to
evolve for years to come and a forward-thinking approach that
considers future markets and requirements can ensure compliance now and for the long-term.
Compliance with the EU FMD is a challenging process for any
manufacturer. Establishing plans now, and considering the impact
serialization will have on each stakeholder in the supply chain, will
be crucial in meeting the 2019 deadline. The implementation of
serialization will bring together many different groups and requires
careful program management. Working with a serialization partner
that can offer a tried-and-tested connection to the EU Hub will
help to alleviate some of the complexity of the task at hand, ensuring both a smoother transition and minimizing risks. CP
BRIAN DALEIDEN is vice president of industry Marketing at TraceLink.
CAITLIN CZULADA is Tracelink’s manager of