Serialization means that a package containing medicines shall be able to be identified and traced in every step in the supply chain, all the way from manufacturer to end consumer/patient.
Why has this step been taken? There are several reasons for the creation of this regulation to be used on medicines. The biggest reason is the safety of the end consumers. The amount of counterfeit medicines that reach the market is growing year by year. These medicines might not reach the quality standards and efficiency that are expected. This will also lead to big losses for the companies that has the patent for the drug. For the end consumer that might lead to lack of effect and unnecessary suffering.
It also happens that different medicines have been switched in the supply chain, as there currently are insufficient controls for it. These switches are not always discovered. Another issue is that genuine medicine ends up in marketing channels not intended to be. As well as in markets not allowed for sales. Finally, the rules and regulations in this area are widely scattered across the globe which makes it difficult for a smaller manufacturer to enter a new geographical area, that step can be too hard.
What does the serialization mean in the pharma industry? Serialization will mean that every package of medicine will get unique identity as well as descriptions that is transferred all the way to the end consumer/patient. It is the manufacturer that starts this process and every part that handles the package adds more information. This is established by using three standardized documents: Transaction Identity (TI), Transaction History (TH) and Transaction Signature (TS). These documents must be transferred in every hand-over according to below.
Take a look at our paper on supply chain within Life Science.
When will the regulation be taken in effect? The start dates are different as the time plans are not aligned in different parts of the world. Here are a few examples: China and India already have corresponding regulations in effect, within EU from 2019-02-09, USA already have regulations in place since 2018-11-26, andBrazil will have during 2020.