10 Tips to Accelerate your EU FMD Serialisation Strategy: Part 3 

10 Tips to Accelerate your EU FMD Serialisation Strategy: Part 3 

Tip 8: Define and agree some governing principles for EU FMD 

The next tip addresses developing and agreeing the key principles required to govern the life cycle of the serialisation capability. These principles should provide guidance for teams on what is permissible or not and would be approved and managed via the governance team. Examples of principles could include: 

  • A single serialisation enterprise management system will be implemented and used by all supply chain nodes for transmission and receipt of serialisation numbers. 
  • A single serialisation issue investigation capability will be established with a physical presence in each geographic region. 
  • Supply nodes must ensure they have competent local capability to support installed on-line printing and verification equipment. 

The benefit of such principles is that they clearly define the ‘rules of the game’ to all parties, thus providing a boundary and a decision-making framework for the development of solutions. If anyone would wish to go outside of or change a principle, they would have to gain permission from the governance team. 


Tip 9: Implement effective cross-functional governance for EU FMD 

Given the cross-functional and cross-organisational nature of the serialisation capabilities, establishing the right inclusive leadership and governance is key to the long-term success of the activity. All stakeholder groups involved in the delivery of the serialisation capability need to contribute effectively or the entire process is at risk of failure. Therefore, all parties must buy into their roles in the processes and actively contribute to them. This will rarely happen if they are simply passive bystanders in the design of the capabilities or the delivery of the resulting activities. 

A cross-function governance team should therefore be established to steer the definition, establishment, ongoing delivery and development of the overall serialisation service across the multiple stakeholder groups involved. This governance body should include membership from all of these stakeholder groups involved in the processes, including where appropriate, external service providers. Typical activities that would be included in the role of your EU FMD Serialisation Governance Team include ensuring: 

  • A clear vision and strategy is defined and communicated. 
  • Decision making is taken with all impacted parties, at the right levels in each of the organisations involved. 
  • A ‘Target Response’ is defined that specifies what the organisation must achieve and by when, given the current state of legislation and the organisation’s considered view of how and when capabilities are required. 
  • Changes to the target response are carefully managed and cascaded to all impacted groups. 
  • Appropriate approval serialisation capability designs. 
  • The performance of the serialisation service is meeting business needs. 
  • The programme of legislative responses and improvement activities are prioritised and approved. 
  • Resources are in place for the serialisation service and improvement activity. 
  • Stakeholder group conflicts are effectively resolved. 


Tip 10: Understand how to start planning your EU FMD serialisation strategy 

As a place to start the planning your EU FMD serialisation strategy, I would recommend a small focussed piece of work which has the following objectives: 

  • Understand the issue as it relates to your business. 
  • Understand the likely impact across your organisation. 
  • Identify, educate and mobilise an effective cross-functional governance team. 
  • Establish an effective legislative monitoring capability. 
  • Define an initial ‘Target Response’. 
  • Define a plan of action. 
  • Identify any initiatives that are currently underway and define how they should proceed.
  • Understand the high level budgetary implications. 

From here, a programme of activity can be implemented to effectively manage the EU FMD legislative risk and oversee subsequent capability deployment. 



I hope you found these 10 tips on accelerating your EU FMD serialisation strategy both useful and helpful. Here are some key learnings that should be borne in mind when defining your EU FMD serialisation strategy: 

  • Recognise the significant supply risk and manage it accordingly, establishing senior cross functional governance early.  
  • Mobilise your regulatory, legal and technical teams to establish effective access to, and interpretation of, the emerging legislative and technical standards.  
  • Actively interpret the evolving requirements and standards for the organisation using tools such as the ‘Target Response’.  
  • Establish a programme of activity to build organisational and extended supply chain capability.  
  • Be realistic about the emerging nature of these capabilities and build in adequate time and resource to effectively test and iterate solutions.  
  • Design serialisation activities to closely couple related actions to minimise the possibility for errors due to abnormal events.  
  • Design both the normal processes and the regularly occurring non-standard events to avoid product supply quickly grinding to a halt.  
  • Ensure cross-functional teams are established to carefully design the interfaces between departmental and organisational boundaries.  
  • Ensure adequate time is allowed for packaging design changes to be made to accommodate serialisation features required.  
  • Be cautious about suppliers who have little practical experience in this area. 

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

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