Now that the first phase of the Drug Supply Chain Security Act (DSCSA) is in effect, you may have learned that an ASN and paper approach for drug tracing, verification and archiving was more difficult than you thought. Or you might not be sure how exception management will work when you get a shipment that doesn't match the information on the ASN.
The next DSCSA phase increases in complexity, with specific serialization and verification regulations that will require many months – even years – of planning and testing prior to implementation.
It's time to get started.Learn More
The European Union has introduced the Falsified Medicines Directive (FMD), and serialization requirements take effect in most EU countries beginning in 2019.
The Directive will affect the entire pharmaceutical industry, from manufacturers and generics producers to wholesalers and distributors.
Packaging and distribution processes must be changed. Physical equipment must be procured and operationalized. Enterprise-wide IT must be implemented. End-to-end serialization testing with supply chain partners must take place.Learn More
In December 2016, Brazil’s new track and trace law was officially signed and published, amending the previous law. After ANVISA finalizes regulatory rules, Brazil’s 3-phase implementation schedule will begin – as early as May 2017.
This comprehensive new regulation mandates that each medicine pack's serialized identity be captured, along with each transaction event as product moves through the supply chain, from manufacturer to dispenser. In addition, these events must be reported to a centralized National Medication Control System.Learn More
In 2013, TraceLink launched the first, integrated end-to-end serialization and government reporting solution to enable pharmaceutical companies and contract manufacturers comply with China's 2009/2012 National Essential Drugs List.
By December 31, 2015, China’s track and trace laws mandate serialization, event tracking from production through distribution, and compliance reporting to the China CFDA for all pharmaceuticals.Learn More
The Directorate General of Foreign Trade (DGFT) in India initiated barcoding and serialization of tertiary level packaging in 2011, and secondary level packaging in 2013.
The DGFT now has new requirements for mono cartons, which contain strips, vials or bottles of pharmaceutical products.
Although mono cartons were earlier to be treated as part of primary level packaging, they are now to be treated as secondary level packaging, introducing new complexities for the pharmaceutical supply chain.Learn More
South Korea’s Ministry of Health and Welfare now requires serialization for 100% of products produced and sold into the South Korea supply chain.
By the July 1, 2016 enforcement deadline, serialized product supply reporting will also begin for all pharmaceutical companies.
South Korea plans to require serialization reporting by wholesale distributors beginning July 1, 2017.Learn More
Since 2012, TraceLink has been helping Life Sciences companies to track and trace pharmaceutical products in Turkey in accordance with the pharmaceutical track and trace system – known as ITS – established by the Turkish government.
ITS requires DataMatrix codes for serialization to ensure the authenticity of pharmaceutical units.
As a result, ITS collects information about all of the steps and transactions that occur for individual drugs as they move through the supply chain.Learn More
Argentina chose to phase in their coming regulations by product type, with the first drug groups meeting a 2012 deadline. By global timeline standards, Argentina was a relatively early compliance adopter.
Regulatory agency ANMAT has yet to announce the date, though, by which all pharmaceuticals must be covered by the country's serialization and reporting requirements. Until then, a significant share of product dispensed in Argentina remains unregulated.Learn More