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Compliance brings change and opportunity, even without legal requirements.
Third-party logistics providers, or 3PLs, play a critical role in the new compliance landscape. While they – like CMOs – don’t have a legally defined role under U.S. DSCSA or EU FMD, their pharmaceutical customers are heavily reliant on them to manage key compliance tasks on their behalf. Because of this, 3PLs’ ability to maintain and potentially grow their customer base will be increasingly tied to their ability to master regulatory processes and data exchange.
Compliance will necessitate change for the 3PLs, both in terms of software solutions and business processes. 3PLs will need an internal serialization solution, as well as a means to integrate with all their pharma customers and those customers’ CMO partners. In the US, they will also have to integrate with all the downstream companies they may need to send data to on behalf of their customers. In Europe, connecting to both national systems and OBPs will be part of the equation.
In the United States
Because DSCSA revolves around changes of ownership, and 3PLs never take ownership of the product they manage, they do not have any explicit requirements under the law. But their pharma customers who maintain ownership of their product are dependent upon 3PLs to manage all the compliance-related tasks for that product -- returns receipt, shipping to customers, and more – when it’s in their warehouse. Additionally, many 3PLs are capitalizing on the business opportunity to provide a logistical service for their pharma customers when it comes to sending the required compliance data – product code, serial numbers, lot-level information – with product when it ships from a 3PL to a downstream customer.
In the European Union
In the European supply chain, there is a much greater reliance on 3PLs than there is in the U.S., increasing both the risk and the opportunity. Like CMOs, 3PLs may not connect directly to the European hub, but must send any required information for upload to the OBP to enable the OBP to upload the data to the European hub. A 3PL may also connect to a national system to perform updates to information about medicines in the system, such as product status.