The lack of a global agreement on one technology or unifying piece of legislation has made implementation of serialisation particularly hard for manufacturers. Many regions plan to set down requirements for serialisation, or have already done so, but so far the only consensus is that a unique identification code (UIC) is to be placed on unit level pharmaceutical products to enable customers to authenticate the code and, it is hoped, to rid a large part of the market of counterfeit products. But every market is moving to different timelines and has variations in practice.
For example, Turkey, China and Argentina have been among the quickest to call for drugs to be serialised; China, however, stipulates a linear code rather than the 2D-style code being adopted by the EU and US. Another country that will see the implementation of new guidelines in 2015 is Saudi Arabia, where drug packaging must be equipped with a data matrix code step by step, followed by serial numbers, in 2016. In Brazil, individual batches have to be serialised as of 2015 and South Korea’s phased schedule also started on 1 January this year.
Meanwhile in the US, the Food and Drug Administration (FDA) is looking to implement a standardised identification for all prescription drugs using a 2D data matrix code in a step-by-step approach until the end of 2023, and in the European Union, the Falsified Medicines Directive (EU FMD) requires packaging to carry a 2D data matrix code and a unique serial number for nearly all prescription drugs, starting from the first quarter of 2018.
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