Healthcare & Life Sciences Regulatory Compliance
Counterfeiters create and sell falsified medications to make money. A fake product according to the EU can have low quality ingredients or wrong quantities; not enough active ingredients; different ingredients from the original; and mislabeled packaging. The last results in the difficulty of catching fake medicine before it reaches a patient or consumer.
Countries and organizations have set out regulations to reduce the risk of sickness or death caused by falsified medications. Every stakeholder in the healthcare value chain is impacted. Each directive varies slightly from the other despite having the common goal.
U.S. Drug Supply Chain Security Act (DSCSA)
The U.S. enacted this regulation in November 2013 as part of a larger act. DSCSA defines a system that will identify and trace prescription drugs. The initiative asks the U.S. Food & Drug Administration (FDA) to handle the licensing of wholesalers and third-party logistics providers (3PLs). GS1 US notes that phase 1 of implementation "focused on the exchange of lot-level chain-of-ownership data among all supply chain partners..." As of February 2019, there is an active pilot project with industry stakeholders for Phase 2 or item-level serialization that has the current compliance deadline of 2023.
Falsified Medicines Directive (FMD)
The European Union's Falsified Medicines Directive took effect February 2019. According to them, it "has a strong legal framework for the licensing, manufacturing and distribution of medicines[.]" It helps manufacturers, wholesalers and logistics service providers within the pharmaceutical industry fight counterfeit medicines thus improving patient safety. The following measures are put into place (source: European Commission):
- Obligatory safety features – a unique identifier (GS1 2D barcode) and an anti-tampering device - on the outer packaging of medicines
- A common, EU-wide logo to identify legal online pharmacies
- Tougher rules on import of active pharmaceutical ingredients
- Strengthened record-keeping requirements for wholesale distributors
These impending regulations will force all players to act. They should be able to verify the authenticity of each medicinal product manufactured or distributed in Europe. This item-level serialization poses some serious operational challenges for each of the stakeholders.
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The Chestny ZNAK track & trace system was created by the Center for Research in Perspective Technologies (CRPT). The purpose is to protect customers from fake goods by ensuring their authenticity and declared quality.
There are five steps that cover the product journey to create a record of the entire value chain. Top of mind is Russia’s Federal Law No. 425-FZ, which has a compliance deadline of July 1, 2020, for tracking pharmaceuticals. However, the country's goal is to fully track all imported products ranging from consumer goods to food & beverages.