Serialization regulations apply to every pharmaceutical supply chain companies around the world.
There is a continuously growing threat of counterfeit drugs, so governments, manufacturers and dispensers need to work together to meet the growing regulatory requirements and to implement successful track and trace strategies to reduce or eliminate these risks. Regulations vary from country to country. The European Union formulated the Falsified Medicines Directive (2011/62/EU) in order to confine counterfeiting, control authenticity and to identify packaging.
“Manufacturers serving the EU are preparing to meet serialization requirements at the package level which are expected to start in early 2018, requirements that include supporting both global and national identifiers and following strict uniqueness regulations.” (Source: http://www.tracelink.com/solutions/global-serialization)
The current regulation focuses on the legal supply chain, from production to the end customer. Beyond the established provisions, it has given authorization for an additional detailed legalization that will be issued in mid 2016 about the safety elements to be placed on the pharmaceutical products. As of the 1st quarter of 2018 the manufacturers should provide every prescription and some over-the-counter medicine with a tamper evident closure and a safety application (2D Data Matrix Code) that is printed onto each product. A centralized repository will be established for track and trace purposes. This means that every box “logs in” during production and “logs out” at the final delivery/dispense.
The Data Matrix Code can include identification code, lot number and expiration date. It is one of the most reliable codes to be found in the industry. It supports thermal transfer and inkjet printing and uses information redundancy which means that the codes can still be read even if they become damaged.
An example of step by step process of track and trace system according to Bosch Packaging
- "A combination of selectable GS1 applications are printed onto each product. These could include the combination of a unique serial number, an expiration date, a batch number or a global trade item number.
- The data is encoded into a machine-readable 2D data matrix code.
- The 2D matrix code and human readable text are printed on the package.
- The camera reads both the 2D data matrix code and human readable text before the software compares the content and checks the printing for accuracy and quality.
- All information can be stored in a centralized database, which enables the tracing of individual products throughout the supply chain." (Source: http://www.boschpackaging.com/en/pa/services/after-sales-services/modernization/track-and-trace/track-and-trace-4.html)
There are of course other track and trace solutions that can be applied like barcode technology or RFID tags but they are either too costly or less secure because they can be easily replicated.
Finding and applying the right serialization strategy can be very beneficial for manufacturers. It helps protect consumer safety as well as brand reputation by making it more difficult for counterfeiters to replicate valid codes. Manufacturers can gain the necessary information throughout the supply chain which also has numerous benefits like cost control or increased shipping accuracy just to mention a few. A proactive approach to serialization will give companies who took the proper steps an advantage in the future against those who didn't take action in time.