The countdown is well under way, with significantly less than 18 months until the EU Falsified Medicines Directive (EU FMD) serialisation compliance deadline – will your company be ready in time? With 32 countries across Europe being affected by this legislation, in this blog series I will discuss 10 tips to consider whilst developing and implementing your EU FMD serialisation strategy. Avoid supply interruption, make sure you have robust, realistic plans to address February 2019 EU FMD requirements.
The EU FMD legislation will require new capabilities to be implemented across many different functions of a typical company. The most obvious include:
- Regulatory and legislative management and government affairs who will have to understand new emerging requirements and represent the company in external influencing and governance bodies.
- Packaging operations, where serialisation will have to be applied to the product packaging at one or more lines.
- Distribution operations, where the more complex serialisation models, this operational impact will extend into these operations in central and/or local markets, where information on individual sale and shipment transactions needs to be gathered and added to the serialisation information.
- IT, particularly for the more complex track and trace models, where significant IT capabilities will be required to manage serial numbers and tracking information related to the product and its movement.
The serialisation strategy of a company and the resultant serialisation service that delivers and maintains the capabilities required, needs to ensure that the requirements of the EU FMD legislation are thoroughly understood and that appropriate capabilities are defined to meet those needs. These capabilities must then be implemented effectively in a timely manner to ensure product supply is maintained. Once serialisation capabilities become available, companies can then look to leverage them for product security and other benefits that are not directly driven by the EU FMD legislation. The following is a series of tips for developing and implementing your EU FMD serialisation strategy.
Tip 1: Identify and interpret the emerging and evolving EU FMD legislation
Serialisation legislation, particularly in its early iterations, tends to be somewhat vague, incomplete and sometimes contradictory. Interpreting the legislation and predicting its impacts can present significant challenges, requiring specific serialisation knowledge as well as new legislative relationships with local legislators.
The situation is no different in Europe as each of the National Authorities, National Medicines Verification Organisations and local supply chain stakeholders agree how each local model is going to work in detail.
Given the uncertainties in requirements and timing, organisations need to ensure there is a clear way of communicating their considered view of the legislative requirements at any particular moment. Failing to do this will potentially result in individual functions or groups creating their own interpretations, which at minimum is wasteful of resources, but at worst results in capabilities being implemented which do not meet the eventual requirements of the legislation.
Tip 2: Understand the full impact of the EU FMD legislation on your company and product supply chain
Serialisation presents a potentially broad impact on a typical organisation. It is important to engage all of the potentially impacted parties early in the impact assessment phase to ensure that comprehensive solutions can be defined.
A further challenge is that multiple pieces of evolving legislation will often impact many of the same capabilities. Understanding these potential impacts and their likely evolution over time is key to ensuring effective solutions are defined and implemented in a timely manner.
Tip 3: Define solutions and implementation plans which strike the optimal balance between ensuring product supply and the caution that is prudent with the EU FMD legislation
There are often a number of supply chain configurations and technical options that can be brought to bear with particular serialisation legislative requirements. Short term tactical options have to be weighed against longer term strategic solutions. Some of the challenges that need to be addressed when defining optimal solutions include:
- Differing serialisation models being called for in differing pieces of legislation.
- Uncertainty in the detailed technical requirements as legislation evolves.
- Evolving and competing serialisation standards being developed by standards bodies and industry groups.
- The requirement for many supply chain nodes and assets to be able to handle multiple legislative requirements simultaneously.
- Deciding on the optimal degree of integration of serialisation capabilities with existing capabilities e.g. production control systems and ERP systems.
- Uncertainty in the timing of legislation.
- Striking the optimal balance between providing new equipment versus retrofitting existing equipment.
- Agreeing interfaces and implementation timelines with third parties.
Defining the timing of implementation plans, to a large extent, needs to be considered hand-in-hand with the solutions themselves. One risk that also needs to be considered is that of the ‘last minute rush’, or ‘Y2K effect’. By this I mean the risk that, as is so often the case with this type of legislation, everyone waits until the last minute to implement solutions, only to find that the supply base cannot cope with the peak in demand, driving up cost and forcing companies into non-compliance. This is a particular concern in the 2018 – 2019 timeframe as the USA, Europe and others all have legislation which becomes effective around this time.
It is crucial that your company has a comprehensive, robust and realistic plan in place to deliver EU FMD serialisation and avoid product supply issues. If you don’t have such a plan in place, act now – contact Be4ward to understand how we can help deliver your strategy and plan quickly, with minimal impact to your team. Should you have any questions about the EU FMD legislation, or would simply like to request a copy of any of our serialisation booklets, please don’t hesitate to contact me at Stephen.McIndoe@be4ward.com
For more information on serialisation, go to our free download section.