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This research surveys several countries’ regulations regarding “serialization” of pharmaceutical products and whether these regulations apply to free medicinal product samples. The attached reports explore the specific “track and trace” or “serialization” laws and regulations in the European Union, Japan, and Turkey.

In the United States, the Drug Quality and Security Act (DQSA)[1] creates track and trace requirements for drug manufacturers, wholesale distributors, repackagers, and dispensers. The DQSA, however, expressly exempts free samples from regulation, as they are not included in the definition of a ”transaction.”[2] 

Under European Union (EU) law, free samples can only be provided in exceptional cases and only to persons qualified to prescribe such products.[3] Furthermore, the European Commission also enacted a delegation regulation that further specifies detailed safety rules for the handling of samples, including ensuring the decommissioning of a sample product’s unique identifier.[4]

While the EU is arguably the prime example of serialization regulations applying to drug samples, other jurisdictions were also researched to explore whether drug samples were covered by serialization regulations.

In Japan, the Implementation Guidelines for the Barcode Labeling of Prescription Drugs provide that pharmaceutical manufacturers and distributors do not have to place barcodes on packages of sample medicines,[5] but have developed standards for sample drugs that limit the quantity that can be provided to medical practitioners.[6]

In Turkey, it is unclear whether or not free samples are subject to serialization, as the existing law is conflicting.[7] However, the existing law does require pharmaceutical companies to establish an “adequate system” to record the manufacture, importation, and distribution of free samples.[8]

While technical aspects of serialization differ across jurisdictions, one widely used benchmark for legislation is the voluntary GS1 standards, and specifically the Global Trade Item Number (GTIN). Globally, it is estimated that 70 countries have based their regulatory requirements for traceability of pharmaceuticals on these standards.[9] GS1 describes free samples as a product category that can be in or out of the scope of the traceability system, depending on the regulatory preferences of the country.[10]

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Elizabeth Boomer
Legal Research Analyst
September 2019

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Last Updated: 12/30/2020