In the US, the requirements for the pharmaceutical supply chain have been tightened to ensure drug safety. On November 27, the final phase of the Drug Supply Chain Security Act (DSCSA) was introduced, in which the Food and Drug Administration (FDA) stipulates that pharmaceutical products in the USA must be electronically traceable at all times in the future, not only at batch level but also at package level. Due to the FDA’s global approach, Arvato expects this to have an impact on Europe in the future and is already prepared for the new requirements.
“With the new DSCSA requirements, an interoperable, electronic system is to be implemented among manufacturers and their trading partners, with which medicine packs can be fully verified electronically via a specific serial number and tracked using a comprehensive track-and-trace system. We can already meet these requirements today,” says Carsten Thiemt, Vice President Quality Assurance at Arvato. In addition to numerous existing customers from the pharmaceutical industry, non-European pharmaceutical companies also benefit from this, as the supply chain and e-commerce service provider offers them a simple and fast market entry in Europe with its integrated distribution network for pharmaceuticals. Carsten Thiemt: “This also includes US companies that expect the new DSCSA requirements to be complied with for their business in Europe.”
The serial number on the packaging consists of the Global Trade Item Number (GTIN), the serial number and batch number, as well as the expiry date of the product. The information is encoded in a 2D matrix code. This requirement has been in force throughout the EU since February 2019, but what is mandatory in the USA in addition to the serial number is the creation of an aggregation structure. This is a prerequisite for an import permit and shows which package is in which shipping unit and on which pallet it is located. “This data must be transmitted electronically to the consignee in advance. If this is not the case, it is not possible to import the goods into the USA,” says Carsten Thiemt. Arvato already has the option of tracking serial numbers from goods receipt to goods issue. The company also already generates and uses aggregation structures. These are used for shipping to Bahrain, China or the United Arab Emirates, for example. In addition, Arvato is already cooperating with a service provider that handles the automated serialization data transfer to the recipient in the USA.
However, these requirements are not completely new territory in the EU – the European Medicines Verification Organization (EMVO) has taken a similar approach and made serialized packaging mandatory. Carsten Thiemt: “We look after customers in Europe whose goods we ship according to the full track and trace principle. However, this is not mandatory and the requirements in the EU are not as strict as in the USA, where the full track and trace, including aggregation, must make the entire life cycle of a serial number traceable. Many European pharmaceutical manufacturers will have to retrofit if they want to continue shipping to the USA.”