Transferring or updating product registrations for a large portfolio of products is a complex task, involving a large amount of interconnected information across various business functions, such as country-specific regulations, supply chain processes, deal milestones, stock-keeping unit (SKU) data, artwork, and labelling requirements. There is a risk that companies may oversimplify and manage the process at too high a level. However, failing to plan in detail and maintain transparency can increases significantly the risk of unexpected delays or compliance errors, potentially resulting in the inability to import or distribute products in some countries for a period of time.

Tip: Determine the appropriate level of granularity for your planning. One recommended best practice is to define an end-to-end process with each SKU aligned to each country’s requirement (SKU by country). These detailed SKU and country combinations ensure flexibility in implementing changes. Ensure you have the appropriate resources and datasets to plan the process and model the variations for each SKU.           

Failing to onboard necessary functions such as regulatory, quality, supply chain, artwork, trade compliance, or commercial, or involving them too late, can result in overlooking crucial aspects of the process, such as failing to identify a country-specific supply continuity risk arising from a cross-functional interdependency. This is usually due to product registration transfers matters not being raised as priorities early on, and underestimated in complexity, or an under resourced agenda item.

Tip: Engage all relevant business functions from the beginning and ensure that dedicated resources are available throughout the process.  Notify product registration transfers as a key cross-functional workstream to the Integration or Separation Management Office early on to ensure it receives the appropriate attention. 

Clarity of roles and responsibilities for decision-making is essential to ensure rapid progress and avoid delays. Throughout the transfer process, important design assumptions and decisions will need to be made, such as defining the exact scope of products, identifying the country-specific regulatory exposure, defining the level of comfort with risk-based approaches, approving deviations to business as usual (BAU) processes, and approving the production of safety stock. Such decisions need to be approved by different functional leads or representatives, and not predefining a decision-making path early on will result in delays along the way.

Tip: Establish a comprehensive decision-making framework before starting the transfer process, creating clear escalation paths and a RACI (Responsible, Accountable, Consulted, Informed) framework, including thresholds and topics for which the project team is authorized to make decisions themselves and those that should be referred up to functional leaders.

Other lifecycle events might interfere with your plans in a variety of ways. For example, regulatory requirements in some countries may specify that new submissions or variations cannot be submitted if there are existing open regulatory submissions. Other disrupting events can include planned product changes or new version launches, capacity shortages in areas such as artworks and labelling updates, or manufacturing capacity constraints. Failing to allow for these events can lead to unexpected problems that will put the progress of the product registration transfers at risk.

Tip: Ensure that product lifecycle management teams are involved in the early stage and collaborate to identify ongoing and upcoming projects that may create a constraint or delay on the transfer of registrations plan with regional and local team members at appropriate junctures.

Regulatory requirements and timelines vary significantly across geographies, posing a challenge for local compliance. For instance, some countries do not allow the distribution of products with ’old’ packaging after a certain grace period, meaning that even if inventory is built up, it cannot be sold, leading to a supply shortage in those markets.

Tip: Develop a robust supply shortage risk mitigation plan for each affected region, exploring options such as negotiations with authorities, accelerating internal processes or building processes for anticipated inventory management requirements.

Throughout the M&A transaction, involving multiple workstreams, local team members need to make decisions and execute activities with strong interdependencies in order to transfer product registrations. Failing to share the relevant and appropriate level of information can lead to other teams making decisions that negatively impact the progress of the transfers or negatively affect the business. For example, a lack of communication with the local supply chain planning team can push them to ordering a large amount of stock in an attempt to mitigate potential supply shortages on their own. This action can change demand forecasts, consequently interfering with the new inventory strategy planned for implementation.

Tip: To ensure alignment, it is crucial to define which stakeholders need to remain informed about which issues. For example, it may be sufficient to inform the Integration or Separation Management Office about the overall progress of activities. At the same time, country project managers would require a plan at the SKU level with a target completion date per activity, including when a dossier needs to be submitted, when a request needs to be updated, or when each artwork needs to be replaced.

Apart from transferring marketing authorisations, other changes might impact the product registrations. For example, M&A deals often lead to transferring production sites to new legal entities or changing the name of the legal entity that owns the site, such as replacing the seller’s name with the buyer’s. Such a change triggers a requirement to submit additional variations worldwide, modifying the supply risk profile and changing the original timeline.

Tip: Ensure that there is a good understanding of the deal implications and connect with global, regional and local regulatory teams to ensure that the scope of regulatory-relevant changes and their implications are clear.

Data that works for day-to-day operations might not be sufficient for a large-scale transfer of registrations. Companies relying on years of workarounds and business-as-usual processes typically face significant challenges in building the end-to-end cross-functional view. Precise and well-connected datasets across all functions and systems are essential for effective impact assessments and planning.

Tip: Begin data preparation early. Engage data experts and system owners to identify required datasets, streamline data extraction, and process updates according to a planned schedule.

Companies that manage product registration transfers within a single business function, such as the regulatory affairs or supply chain function, often omit some costs when budgeting for the transfers. Product registration transfers represent a significant amount within the integration or separation budget, and failing to budget fully for the various cost elements can lead to complications and delays in the implementation phase.

Tip: Prepare a detailed budget plan that includes the costs the needs of different functions and stakeholders against the total duration of the project, which can often be two to three years. 

Depending on the company culture and the allocated project budget, companies may staff the product registration transfer exclusively with internal resources, or may choose instead to outsource most activities to contractors and advisors. These are two extreme choices which are likely to be detrimental over the long run and for the sustainability of the project. This is because the activities to complete and milestones to reach are usually too many to be performed exclusively by internal resources: specific product registration transfer expertise may be limited within the organisation, leading to the team taking shortcuts and missing critical considerations. On the other hand, if the product registration transfer activities are outsourced, this can lead to high dependence on external stakeholders, including during the long implementation phase.

Tip: Look both internally and externally for resources with relevant knowledge and experience. Internal resources will provide an invaluable understanding of the company’s processes and ways of working and are a better fit for long-term execution. Use external contractors for temporary capacity increases, such as for dossier preparation. Consider having support from external advisors and SMEs during phases for scoping, strategy, and planning, where their expertise and experience are needed, such as modelling the sequence of activities at the SKU level. With external resources, it is important to define a plan to hand over externally performed activities to internal stakeholders at the appropriate times.