France is first to set the code

With the new traceability regulation now enforced in France, Avery Dennison discusses the implications for those manufacturing and marketing drugs in France and looks at whether the rest of Europe is likely to follow

The Data Matrix code will contain a unique number printed on each box, in accordance with the new principle of ‘serialisation’

With the new traceability regulation now enforced in France, Avery Dennison discusses the implications for those manufacturing and marketing drugs in France and looks at whether the rest of Europe is likely to follow

The French pharmaceutical industry is adopting a Data Matrix system to meet new regulations on the traceability of products, with the aim of improving patient safety. Back in January 2011, regulations created by the French Agency of Sanitary Safety and Health Products (AFSSAPS) established an improved coding standard for the French pharmaceuticals market. The new standard is designed to improve the traceability of medicines distributed in France and to increase safety. It requires that a Data Matrix barcode containing the new CIP 13* code, a batch number and the medicine expiry date is printed on the production line as a replacement for the current French pre-printed CIP 7 standard.

As a result, the quality of traceability will move to a higher level. The Data Matrix code will contain a unique number printed on each box, in accordance with the new principle of ‘serialisation’. Avery Dennison, with its printing, identification and product traceability expertise is one of the first suppliers to propose complete Data Matrix integration solutions. These solutions will enable any pharmaceuticals manufacturer to comply fully with the new regulation and improve traceability along the whole supply chain.

The regulation derives from the need to increase the control of the supply chain of medicines to guarantee the safety of patients. The traceability of medicines is a crucial issue for hospitals and healthcare establishments. According to surveys, one prescription out of every 100 in Europe is improperly dispensed, which represents 1–2 million medical incidents per year for a country such as France.

The aim of the new standardisation is to improve the efficiency of batch recalls, to reduce errors, to combat counterfeiting and reimburse-ment fraud and to increase the transparency of the distribution chain. From now on, manufacturers, distributors, pharmacies and hospitals will be required to trace products by an electronic receipt notice (EDI).

Valérie Marchand, health sector manager of GS1 France, says: ‘The new regulation will enable pharmaceutical companies to know quickly and accurately what they have supplied, both to the distributors and to the hospitals, but traceability often stops there.

‘The strong point of this new regulation for the supplier is that it will send the information included in the Data Matrix code electronically. It will allow automatic integration by the various players in the traceability information chain, while also improving product monitoring and enhancing flow management. In a nutshell, the regulation improves the traceability of products from the production chain to the patient’s bed.’

European standardisation

France and Turkey are the first two countries to adopt the Data Matrix system in their traceability regulations. What has become an official regulation in France could become a rule shared by all of Europe in the future, given that EFPIA (European Federation of Pharmaceuticals Industries and Associations) recommends the adoption of the Data Matrix system to GS1 standards as a common traceability standard. Moreover, Germany, Spain and Italy also envisage adopting the Data Matrix system in the future.

The Data Matrix marking system was chosen due to the need to encode more information on each label but maintaining a print size small enough to allow use on pharmaceutical products cases. Data Matrix marking allows a large storage capacity (more than 3,000 characters) on minimal physical dimensions, thanks to 2D coding. The additional information contained in the Data Matrix code facilitates the electronic automation of product monitoring in the supply chain to allow batch recalls or automatic detection of out-of-date products. Finally, its cost remains very competitive (marking costs between 0.1 and 0.2 eurocents per label).

Marchand is realistic and believes that, despite the regulation’s many benefits, the costs incurred mean the majority of pharmaceutical manufacturers throughout the world are unlikely to begin using a 2D barcode on their production lines until a law is enforced in their country.

‘Manufacturers who wish to sell their medicines in France, however, must make sure that products are labelled with a GS1 Data Matrix 2D barcode – all the required information needs to be included in order to comply with the French regulation.

‘Therefore companies who use this code on their production lines for France will certainly reap the benefits if they then choose to continue doing so on the remainder of their products not intended for France.’

Roger Lamb, healthcare sector manager at GS1 Healthcare UK, says: ‘The Department of Health’s Procurement, Investment and Commercial Division (PICD) in the UK is currently discussing the adoption of GS1 Data Matrix with the pharmaceutical industry.

‘There is a Data Matrix working group, which is a sub group of the GS1 UK Healthcare User Group, and discussions are taking place with manufacturers, trusts and solution providers regarding a similar regulation.’

Lamb says that work is ongoing in the UK and the Department of Health PICD aims to consult widely and thoroughly before any decisions are made. He adds: ‘France’s decision to enforce the GS1 Data Matrix 2D barcode has certainly stimulated a debate within the UK industry.

‘Although there will be substantial costs involved in implementing such a system, equivalent benefits will be derived by companies. For manufacturers in the UK wishing to learn more about implementing a GS1 Data Matrix 2D barcode I would advise that they contact GS1 UK and join the work programme, which will ensure they are kept up to date with any progress.

‘It is extremely important for pharmaceutical companies to be fully prepared for the new system in every way possible.’

The difficulty of implementing this new marking lies in the correct integration of the new printing and control system. With its experience in identification systems, notably deployed for the social security label, Avery Dennison can provide Data Matrix solutions that can help pharmaceutical companies achieve full compliance.

The company is at the forefront of the Data Matrix barcoding technology, offering three innovative and flexible solutions for Data Matrix marking and control. Easy-to-integrate, these solutions can fit the specific needs of every pharmaceuticals manufacturer.

The main constraints for pharmaceuticals managers are the lack of space on production lines for adding new labelling equipment, the multiplication of interfaces and communication issues between the different elements (marking, control, automation, line supervision, etc.) as well as the need to ensure product cases are delivered to the label applicator consistently and accurately. Avery Dennison has flexible Data Matrix solutions for all of these problems.

adaptable to all situations

The first solution upgrades an existing labelling machine, without affecting the dimensions. The update of the AVL labeller is a cost-effective upgrade of a proven labelling machine, but with new features added. Avery Dennison equips the machine with an interface that centralises the management of all machine functions: marking, labelling and control of the Data Matrix.

The second solution updates the production line by adding a dedicated Data Matrix module. The company offers a compact, independent module (600mm) dedicated to Data Matrix marking. The accurate and consistent movement of product cases through the labelling area ensures the best print quality: this solution uses the same type of vertical double-band conveyor as the labellers.

Finally, if a manufacturer is establishing a completely new production line, the company proposes the latest version of its AVL-DM labeller. This system integrates the printing of the Data Matrix and control over the Data Matrix code, in addition to the classical functions of deposition and inspection of the social security label. Once again, the use of a single interface makes it possible to easily manage the different functions of the machine and maintain a reasonable load (1,000 or 1,300mm).

The company has already been selected by several major players in the sector to support their implementation of Data Matrix labelling systems and future compliance.

Frédéric Lemaire, Southern Europe manager for Avery Dennison’s major accounts, says: ‘Laboratories are aware of the challenge presented by Data Matrix adaptation. They will need the right equipment, but experienced contractors will also provide them with reliable and easy to integrate solutions.’


* GS1 standardised


Frédéric Lemaire, Southern Europe Manager for Avery Dennison major accounts

T +33 1 41 31 28 24