Mergers, acquisitions and divestments (M&A) can be complicated to plan and execute at the best of times, but now with serialisation to factor into this planning, the task has become significantly more challenging.
It is easy to underestimate the implications serialisation can have on a merger, acquisition or divestment and without the correct knowledge at the start of these programmes, time can be lost in execution, benefit delivery delayed, unnecessary costs incurred and finally, ongoing issues during the shelf life of products already on the market.
Traditionally M&A planning has involved coordinating the regulatory licence transfer processes with related artwork/pack change programmes and other supply chain operational changes. On top of this there are the system and data considerations to factor in. A M&A is already a set of complex moving parts which have to be understood and carefully planned. Serialisation, by its very nature, cuts across many of these areas and therefore needs to be factored in from the start.
What make this task more difficult is that unfortunately most legislation and serialisation systems which operate across the supply chain are not built with M&A activity in mind and therefore lack the functionality to accommodate the transfer of products between companies.
The European Medicines Verification System (EMVS) is one example where the systems do not fully support M&A activity. The European Medicines Verification Organisation and its key stakeholders have recognised this and are already working to address this gap. Detailed user requirements should be completed sometime after the summer 2019, however we should probably not expect the EMVS to be upgraded until 2020. To help stakeholders work around this lack of functionality an interim guide has been written which should help provide guidance in the short to medium term.
In addition to the lack of functionality of external systems, there are many internal factors you must consider within your company. These include:
• Serialisation impacts on the artwork/ pack change processes
• Serialisation service agreements to be built into M&A terms
• Data access and archiving
• Business process impacts
• Customer service and falsified product investigations
• The Product code (GTIN) transition management approach
• Serial number generation and uniqueness maintenance
• Master data implications
Although serialisation is a niche area of merger and acquisition management, by including these types of topics in early planning it is possible to avoid the potential serialisation issues.
If you require help, advice or assistance with understanding and planning merger and acquisition activity for serialisation or any other aspect of your company’s serialisation strategy, please get in touch. If you 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
Be4ward provides specialist consulting services to the pharmaceutical and other highly regulated industries. We deliver value to our clients through a combination of deep subject matter expertise and excellent consulting skills. Whilst we have a thorough understanding of the supply base in our areas of focus, we pride ourselves on providing entirely independent advice to our clients.
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