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Serialization: Are You Ready For Changing Regulations?

By John Hannon , April 12, 2016

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If the pharmaceutical distribution network is at risk, so is patient safety. With counterfeit drugs on the rise, serialization programs are being implemented to safeguard the integrity of product reaching the market. Serialization also provides better controls to communicate recall information should it become necessary.

Changing Regulations

Implementing serialization requirements is a complex challengewith dealing with multiple countries, and global supply chain. A number of countries, such as China, India, South Korea and Saudi Arabia have already enacted regulations requiring serialization, thereby pushing European and US based pharmaceutical manufacturers into developing serialization programs for shipments into these countries. The timeline below represents requirements in the US. 

 

United States Overview

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The full complement of US requirements phases in between 2015 and 2023. The Drug Supply Chain Security Act (DSCSA)requires that manufacturers mark packages with a product identifier, serial number, lot number, and expiration date by 2017. Wholesale distributors and other supply chain companies should be gearing up for end-to-end serialization testing with their manufacturing partners well in advance of the deadline to allow time for any necessary adjustments. Dispensers – the only supply chain business to have a different lot level deadline – should be planning for July 1 compliance, by which they will need to be able to receive and archive T3 information, and be prepared to produce it in the event of an inquiry.

 

European Overview

European companies who manufacture, sell, or dispense medications in the European Union have until February 2019 to comply with new track and trace regulations outlined in the Falsified Medicines Directive (FMD). The main requirements presented in the FMD involve, compliance reporting, and verification. Medications in Europe are generally packaged and sold at the “unit of use” level, so the volume of product that needs to be serialized and the magnitude of transactions will be two to five times what companies will see in the U.S. where the saleable unit is in larger bulk quantities. Overall, the universe of data to be produced, managed, and reported on will be massive, with the added complexity that each EU Member State is provided flexibility to apply their own unique requirements (see map).

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China Overview

China has had a phased implementation of their track and trace regulations based on therapeutic drug class, with 2013 and 2014 deadlines covering select products on their Essential Drug List. As of China’s final December 31, 2015 deadline, however, all pharmaceutical products will be covered under China’s unique requirements, which include serialization and government reporting.

Brazil Overview

Brazil has the most complex track and trace regulations in the world today. Compared to other global regulatory requirements, Brazil is a hybrid model - under their law, the primary burden for compliance falls on manufacturers, with wholesale distributors and pharmacies sharing some reporting responsibility.

 
WHAT IS SERIALIZATION?

Serialization refers to the process of applying a unique identifying number, also referred to as a Standardized Numerical Identifier, or SNI, to each final dosage unit produced by the manufacturer. The SNI and associated drug information is stored in a database which, ultimately, becomes the means for confirming the legitimacy of drug products in the field. 

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WHO’S RESPONSIBILITY IS SERIALIZATION?

Each level of the distribution network is responsible for maintaining and passing along the “pedigree” of the drug unit— from original manufacturer of the product Stock Keeping Unit, or SKU, to the supplier, to the prescribed customer. The information collected and disseminated serves as a compilation of the “ownership and transfer” for each serialized unit of pharmaceutical product along the distribution chain.

In its simplest form, a drug unit could be direct shipment from manufacturer to customer— manufacturing for sale to a government entity, or it could be a very complex process involving many organizations in the distribution network. 

In the event the original pedigree, as established during manufacturing, is altered (e.g. pallets broken down to individual cases), a new serialized pedigree must be established while still maintaining the history.  Each level must have processes in place to complete a revised pedigree in those situations. Those levels may include the vision system, packaging line, database, inventory, and each stop within the supply chain.

 

 

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