Ensure you understand the evolution of serialisation legislation and instruct the organisation accordingly
Serialisation legislation can be somewhat vague, incomplete and sometimes contradictory, with individual pieces of legislation often evolving over a long period of time. Interpreting the legislation as it evolves and predicting its impacts can present significant challenges. We have found that there are several key pieces of expertise required to successfully interpret evolving requirements. Local regulatory and legal representatives will be required to obtain the legislation, manage dialogue with the regulatory agencies, and interpret its application to a company’s products and the consequences of non-compliance. Serialisation expertise is clearly a necessity, both in the technical aspects of the topic, but also in the ways that serialisation legislation typically evolves. Local and central management also need to be involved to ensure that the requirements are interpreted appropriately in the context of the local environment and company situation. Also, an important and practical point to remember is that the legislation will more likely than not, need accurate translation into English.
When considering the timelines allowed in the legislation, history has shown that timelines are often vague and subject to change. However, when implementation dates are finally set, they often do not allow enough time for robust implementation. Therefore, waiting until the legislation is clear can result in missing deadlines.
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 to the various project teams who are responsible for designing and implementing solutions. Failing to do this will potentially result in individual functions or groups creating their own interpretations of legislation and timelines, 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.
I hope you enjoyed this instalment on Things we wish we had known before starting a serialisation program or project.
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