In the last article we talked about unique identification and getting the unique identification onto the product or shipping unit. In this article we will discuss publishing the related serialisation information and one of the common serialisation models, Authentication.
Product Information Notification
Typically, once product packaging of one or more levels has been uniquely identified, this information, together with other information related to the product and manufacturer is passed to an external agency database.
The information in this database is then used by the downstream supply chain and other agencies as described later in this series.
The triggers and grouping of the information transfers will vary according to the specific requirements of the legislation and the local business processes. In the simplest of models, the information can be transferred at, or around the time when the product packaging batch has been completed.
Authentication is a term often used to describe the following process of checking the legitimacy of a product using it’s serialisation.
One of the primary purposes of serialisation is to enable individuals in the downstream supply chain to scan a product and compare the information on the product packaging with the information stored in the external agency’s database. If the two sets of information match and it is evident that the product has not been tampered with, then it will be highly likely that that the product is legitimate.
As an example, a patient might scan a product pack with a smart phone using it’s in-built camera. Using an application, the smart phone would then request information related to the unique identifier contained in the machine readable code and display it to the patient. The patient would then compare this information to the information contained on the packaging. If everything matched and the tamper evident sealing was still intact, the patient could have greater confidence that the product was legitimate.
A number of serialisation legislative models stop at the requirement for a means of Authentication. It appears that the recent European Union falsified medicines legislation 2011/62/EU is one such example. Many would argue that this level of serialisation provides an improved level of protection against falsified products and fraud that is sufficient, at least for the current round of legislation.
This is one in a series of articles outlining the requirements of serialisation and related product coding legislation, discussing what needs to be done to address it and identifing some next steps to effectively manage the risk. Please help us improve the thinking by adding your comments and share this with others who may have a view.
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