In the course of working with hundreds of companies across the pharmaceutical supply chain, we receive many questions on the upcoming EU FMD requirements. In this article series, we’ll answer one of your questions each week. This week, we look at what data upload to the European Hub means to companies who are aggregating.
The European Hub
The European Hub, to which all Marketing Authorization Holders (MAHs) of in-scope medicines must upload their product data as part of EU FMD, requires the data to be uploaded in a very specific format. This is leading MAHs to question how the new requirement will tie in with their existing processes, such as aggregation.
Aggregation is not mandated under EU FMD; however, you may already be aggregating due to requirements in other markets that you supply, or simply out of choice for operational reasons.
Aggregation data such as pallet ID is not a field that is accepted by the European Hub, meaning that it cannot be uploaded. You either need to delete it from your data set before performing a bulk upload, or manually enter your product data for every item. Whilst the former could lead to data discrepancies, the latter is time-consuming and leads to operational inefficiencies.
Companies who work with TraceLink have another option. The TraceLink solution is configured to automatically exclude aggregation data from the upload to the European Hub, without manual manipulation by the Onboarding Partner (OBP). It does this by storing all of your serialization data in the TraceLink repository including aggregation data, so that updates can be performed at the highest level for operational efficiencies. TraceLink can automatically send this data to the European Hub from your repository. You also have the option to select the pallet ID and TraceLink will upload just the serial numbers contained within that pallet. Our solution finds the relevant data, configures it to the correct format and uploads it to the Hub. Aggregation information can also be exchanged with your trade partners, such as 3PLs, so that they can achieve operational efficiencies by utilizing your aggregated information.
With the TraceLink solution, your business can continue aggregating without having to alter your processes or spend time on administrative tasks in order to achieve EU FMD compliance. Learn more about our European Union compliance module.