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The European parliament finally published the delegated acts in February of this year, allowing producers 3 years to become compliant with the regulations. The addition of a unique code on the carton coupled with an anti-tamper device on the carton itself is a positive move by European Authorities to protect the consumer from counterfeit products entering the supply chain. The law states that the regulation will now enter into force on February 9, 2019. From that date, all medicine packs sold in the EU must carry a serialized unique identifier (UI) code within a 2D datamatrix barcode, an anti-tampering device on the outer packaging, and be verified at the point of dispensing to the patient. 
 
There has been an inexorable trend towards traceability in everything we consume. This trend will continue and it is gathering momentum. In Pharmaceuticals, market growth for counterfeit product has been assisted by the increasing use of online Sales.  In order to counteract this, the Pharmaceutical sector has led the way in terms of agreeing a set of global standards for this new business process, which has made it easier to implement. 
 
The Delivery
 
For the supply chain, especially the smaller companies who do not have the benefit of a team of experts, the next few years could be very challenging. However on a positive note, while the vendor base is relatively new, the larger players in the market have now got significant experience and the ‘serialisation’ offering from many companies is fine tuned to a large degree.
 
The successful delivery of a Serialisation project involves significant effort on the part of the Producer. It’s multidisciplinary and will inevitably impact on OEE. From experience, the key players are ultimately two people - The Project sponsor and the Project Manager. The sponsor is often overlooked,  but because of the impact of Track & Trace on the business, it’s key that the sponsor and maintains a helicopter view of things. The project Manager is the person who pulls the team together and keeps the implementation on track. He needs resources and expertise from Regulatory affairs, Process and Equipment Engineering, Artwork, Validation, IT and also a number of external vendors.  Each department is impacted to a greater or lesser degree. The successful Project Manager needs to have some Domain Knowledge, so he understands the key milestones and also have the strength of character and the diplomatic skills to coax, bribe, cajole his team. 
 
The vendor base is quite diverse, as more and more people enter the market. However, it’s important to note that this is a business process; it’s not a case of buying a new piece of hardware! Applying the datamatrix and the Tamper proof label is the easy part. The content of the codes, the additional data to be printed on the product, the shippers, the pallet labels, understanding how the data get  to the line, how does it get from the line to the European Hub, what are the steps in between, how will it impact other parts of the supply chain …..All these questions need to be answered. 
 
Remember, the industry has limited capacity.  Don’t wait around too long. The clock is ticking.
 
Mettler Toledo/PCE through their Irish partners IPT will be holding a Track & Trace seminar in Dublin on October 5th. 

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SERIALISATION OF PHARMACEUTICALS

THE KEY TO SUCCESS FOR THE PHARMACEUTICAL INDUSTRY