Deliver EU FMD Serialisation Solutions

Avoid supply interruption, make sure you have robust, realistic plans to address Feb 2019 EU FMD requirements

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.

EU FMD image 2d barcodeThe countdown is well under way, with significantly less than two years 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, Be4ward help to ensure you have a robust comprehensive strategy and implementation plan in place before it is too late. Furthermore, following the planning stage, Be4ward has a comprehensive suite of serialisation, program and project management services that can help you deliver your serialisation solutions in an efficient and effective way, minimising supply risk.

If you are currently dealing with the US DSCSA legislation, you will already be aware of the complexities, issues and risks involved in delivering serialisation capabilities, even though the US is only one market with a relatively simple November 2017 requirement. Some companies are waiting to tackle EU FMD until after their US solutions are in place. This is a very high risk strategy for many companies, given the complexities and real lead times of delivering serialisation solutions for Europe.

Don’t let internal issues stop you acting now

Currently dealing with the US DSCSA legislation?

  • Is your team telling you they have no capacity to start planning for EU FMD until after DSCSA is complete?
  • Are you concerned by the number of products and markets in Europe, but your team is telling you that EU FMD is just one piece of legislation, like the US, and therefore it will be simple to implement?
  • Do you have a small number of CMOs and packaging sites you are connected to in the US, but in Europe you have lots more?
  • Are you hearing discussions about the local country requirements in Europe and that there are still a lot of details to be decided?

If you can answer yes to any of these questions, it is time that you understand the full impact of the legislation and local requirements on your organisation before it is too late, and make sure you are doing the critical path activities you need to be doing now.

 

New or inexperienced with serialisation?

  • Is your company new to serialisation, or has only dealt with serialisation locally for the likes of Turkey?
  • Is your team telling you that EU FMD is just one piece of legislation, therefore it will be simple to implement?
  • Are you hearing discussions about the local country requirements in Europe and that there are still a lot of details to be decided?
  • Are you concerned about who is going to pay for the EU national systems access?
  • Are you concerned that you do not have the skills, knowledge or capacity internally to understand the true impact of serialisation on your organisation?

If you can answer yes to any of these questions, it is time that you understand the full impact of the legislation and local requirements on your organisation before it is too late, and make sure you are doing the critical path activities you need to be doing now.

 

Are you a CMO that is unsure of your responsibility and involvement in preparing for the EU FMD legislation for your customers?

  • Are you a CMO that is receiving questions from your customers about how you will tackle EU FMD serialisation for them, but you do not feel fully informed to answer them?
  • Are you frustrated that your customers are not being clear about what they want?
  • Are you concerned about who is going to pay for these new serialisation capabilities?
  • Are you concerned about how to deal with multiple different customer requirements?
  • Are you concerned that you will be asked by your customers to deal directly with the EU hub (EMVS) and national systems (NMVS)?

If you can answer yes to any of these questions, it is time that you understand the full impact of the legislation and local requirements on your organisation before it is too late, and make sure you are doing the critical path activities you need to be doing now.

 

Be4ward provide independent support

Be4ward has local teams in Europe that can help you and your company understand and implement solutions for the EU FMD legislation. Here are some of the key reasons why you should engage with an independent consultancy like Be4ward:

  • Your company does not have the internal resources and/or capacity to develop internal knowledge and stay up to date with the evolving legislation and local country requirements. Be4ward is helping many clients understand and stay up to date with the legislation and local requirements. We are also active members of the GS1 EU FMD implementation team.
  • You do not have the time or budget to make mistakes. Be4ward have learnt through experience of the many issues and risks associated with serialisation through their work with other client’s projects, so you don’t have to.
  • You want to understand all your options. Be4ward can help you understand that you have options in how to meet the EU FMD legislation deadline and help you choose the right solutions for your particular situation.
  • You need help understanding the supply base and selecting appropriate solution provider(s) for your situation. Be4ward have a thorough understanding of the supply base, whilst at the same time being completely independent from it. Therefore, we can help you select the most appropriate solution provider(s) for you.
  • You need experienced subject matter expert support in your implementation phase. Once you get into implementation, you will likely need incremental resources of varying different skills and knowledge at various times to help design, develop and implement serialisation capabilities. Be4ward can provide you with these crucial resources to help you succeed in your implementation.

How Be4ward can help

Be4ward have been working with the world's largest and smallest Pharmaceutical companies and their CMOs to deliver fit for purpose, robust serialisation solutions for EU FMD and other serialisation legislations. Here are some of our service offerings that will ensure your company efficiently meets the EU FMD February 2019 deadline:

Serialisation Strategy Development

Be4ward's strategy development service brings together a number of our serialisation products to help organisations develop an initial understanding of how to tackle serialisation. For more information on this service, click here.

Serialisation Health Check

If you already have a serialisation program in place, our Serialisation Health Check can help you understand any potential issues and gaps you may have over looked and put in place the appropriate corrective measures. Contact us at enquiries@be4ward.com to get more information.

Vendor Selection Service

Implementing serialisation capabilities involves selecting a number of different vendors to provide different aspects of the end-to-end solution. Many of these purchases are significant and, for many companies, require a significant amount of rigor to ensure that the most appropriate providers are selected. We typically run vendor selection activities with our clients to:

  • Define requirements in the process
  • Understand the market place
  • Run the selection process
  • Engage with potential vendors for quotations
  • Select the appropriate vendor for our client’s situation
  • Agree appropriate contractual terms and service level agreements

For more information on this service, click here.

Other Serialisation Services

Be4ward provides various serialisation services that can help your company meet serialisation deadlines in a time effective and efficient manner:

EU FMD serialisation services

Contact us

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 us at enquiries@be4ward.com for more information.

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