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Enter the DataMatrix

With new traceability regulations in France coming into effect in January 2011, it is crucial for distributors to upgrade to DataMatrix technology, argue Valérie Marchand of GS1 France and Frédéric Lemaire at Avery Dennison

France will adopt the DataMatrix system from 1 January 2011 to comply with new regulations created by the French Agency for the Sanitary Safety of Healthcare Products (AFSSAPS). The new traceability guidelines will require all medicine to display a barcode containing the new CIP 13 code, the batch number and expiry date. DataMatrix barcoding technology will become the accepted standard across France to meet new guidelines on the traceability of pharmaceutical products, subsequently increasing patient safety.

The new AFSSAPS regulation will require pharmaceutical companies who wish to market their products in France to print a DataMatrix directly onto the secondary packaging, as well as the marketing authorisation (AMM) 13-character code, a batch number and a use-by date. The second section of this regulation strongly recommends that pharmaceutical companies, distributors and hospitals be able to trace products through the receipt and transmission of an electronic shipment notice. The main goal is to ensure the traceability of the medicine right up until it reaches the patient.

The DataMatrix code will contain a unique number printed on each box, in accordance with the new principle of ‘serialisation’. GS1 DataMatrix is a twodimensional code; its minute size is highly suited to small products, while making it possible to hold a great deal of data. Another type of barcode, the GS1 128, is able to integrate traceability data. These solutions will enable any pharmaceuticals manufacturer to fully comply with the new regulation and improve traceability along their whole supply chain.

IMPROVING THE DISTRIBUTION OF PHARMACEUTICAL PRODUCTS

This regulation derives from the need to increase the control of the supply chain of medicines in order to guarantee the safety of patients. The aim of the new standardisation is to improve the efficiency of batch recalls, reduce errors, to combat counterfeiting and reimbursement fraud, and increase the transparency of the distribution chain. From 2011 onwards, manufacturers, distributors, pharmacies and hospitals will be required to trace products by an electronic receipt notice (EDI).

The new regulation will enable pharmaceutical companies to work out quickly and accurately what they have supplied, both to distributors and to hospitals. Traceability often finishes once the product reaches the end user, but the strength of this new regulation for the supplier is that it will send the information included in the DataMatrix code electronically. It will allow automatic integration by the various players in the traceability information chain, while also improving product monitoring and enhance flow management. In a nutshell, the regulation improves the traceability of products from the production chain to the patient.

ADVANTAGES OF THE DATAMATRIX SYSTEM

This system was chosen because new regulations require three types of information: the new CIP 13 code; the batch number; and expiry date of the medicine. If stored on a conventional uni-dimensional barcode, this amount of information would need a large printed area, making it impractical for many smaller medicine packages. The serialisation number will be added over time. DataMatrix marking has a large storage capacity and minimal physical dimensions, making it ideal for this application. This system facilitates the automation of product monitoring in the supply chain to allow batch recalls or automatic detection of out-of-date products. Finally, its cost remains competitive (the marking cost is between 0.1 to 0.2 eurocents).

DataMatrix and radio-frequency identification (RFID) each meet different needs and priorities. While RFID is more often used in logistical applications for high value-added products, the cost price of the chip is higher than the DataMatrix. Using RFID obliges hospitals or pharmacies to be equipped with RFID scanners. It is also necessary to have a 100 per cent reading rate, because the interest of RFID, for example, is to be able to read an entire pallet, which will facilitate quantitative inspection on receipt, while maintaining very important quality controls in the case of health products. In addition, DataMatrix will help prevent counterfeiting by integrating a series number into the symbol and linking scanning systems to databases that reference these series numbers. This makes it possible to verify whether the manufacturer has indeed placed this product on the market and whether it has already been registered for sale or not.

DATAMATRIX SOLUTIONS FOR ALL SITUATIONS

DataMatrix will not only benefit safety standards but also supply chain operations. Currently, the main problem for pharmaceuticals managers remains the lack of space on production lines for adding new labelling equipment. Furthermore, in order to guarantee good quality DataMatrix marking, it is absolutely essential to ensure products are packaged correctly. This is compounded by the multiple interfaces and systems that exist between various elements of the production line (marking, control, automation, line supervision, and so on). Using DataMatrix will enable pharmaceutical companies to streamline all requirements into one barcode, which is small but capable of storing all the necessary information. All pharmaceutical manufacturers recognise the importance of the DataMatrix system and the potential impact on their production procedures. 2010 will be a busy year in preparation for the new DataMatrix standard, both in France and internationally.

A POSSIBLE EUROPEAN STANDARDISATION

France and Turkey are the first two countries to adopt the DataMatrix system in their traceability regulations. Turkey has requested the equivalent for all of the medical products supplied in hospitals, with a series number for some of these. What has become an official regulation in France could become a rule shared by all of Europe in the future, given that European Federation of Pharmaceuticals Industries and Associations (EFPIA) recommends the adoption of the DataMatrix system to GS1 standards as a common traceability standard. Moreover, Germany, Spain and Italy also envisage adopting the DataMatrix system in the future.

It is possible for a European standard, and even an international standard, to evolve with a target that everyone might have the same criteria across the world, but this takes time. GS1 has already been working with the FDA on regulation at the international level for the past two years. As the person in charge of this file at the European Commission has said, reaching an agreement among 25 countries is not straightforward.

In the US, the FDA are likely to promulgate a law on unique device identification (UDI) that makes it possible to track implantable medical devices. This law would then be taken on by the European Commission for adoption by all of the countries in the EU. As soon as the FDA has completely established legislation that is common to the US, the European Commission will adopt the work so that European legislation also exists.

Using an international standard allows pharmaceutical suppliers to harmonise their product marking systems for all of their customers, regardless of the countries concerned. Hospitals will be able to manage all of the products supplied and received based on the same structure, and thus trace them more effectively. All of this will make it feasible to reduce the costs linked to successive handling of products and, in turn, improve patient safety.

CONCLUSION

As France adopts new traceability regulations starting in January 2011, many European nations are following quickly – requiring manufacturers to comply and adopt DataMatrix technology. The DataMatrix barcode will not only improve supply chain efficiency, but also help prevent counterfeit medicine and increase patient safety.


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Valérie Marchand is Healthcare Manager at GS1 France. She has a degree in Marketing and Diploma of Higher Specialised Studies (DESS), and has had first-hand experience in a solution provider company before joining GS1 in 1989 to promote a value added network. After being in charge of the deployment of the GS1 system in the non food sectors, she is now in charge of the healthcare sector in order to promote adoption of GS1 standards in hospitals, suppliers and other institutions. She is involved in the global GS1 Healthcare Group and is due to facilitate the AIDC Implementation Guideline Work Group. 

Frédéric Lemaire is Head of Market Development Southern Europe at Avery Dennison PSD. After graduating with a degree in Electronic Engineering in 2001, Frédéric joined Dassault AT as pre-sales support manager specialising in systems for ticketing and boarding control for air transport. In January 2008, he became Head of Major Accounts for KAM Industry France, prior to joining Avery Dennison in 2010.

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Frédéric Lemaire
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