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French Labeling Directives Integration Solutions for New French Labeling Directives

Editor: Dr. Jörg Kempf

Companies wishing to continue selling their pharmaceutical products in France will now need to comply with new regulations. Integration solutions for labeling and data matrix checking will provide a smooth transition.

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In comparison to a one-dimensional barcode (1D code), the data matrix code offers a much higher information density per unit of surface area. (Picture: Avery Dennison)
In comparison to a one-dimensional barcode (1D code), the data matrix code offers a much higher information density per unit of surface area. (Picture: Avery Dennison)

With effect from January 1, 2011, the new regulations introduced by the French health products safety agency AFSSAPS (AFSSAPS = Agence française de sécurité sanitaire des produits de santé) will alter the way coding standards are handled in the French market. The aim here is to increase the traceability of drugs from production to the patient in order to improve consumer protection.

In the past, the French CIP-7 code was printed on the product on the production line in the form of a traditional barcode. With immediate effect, French pharmaceutical companies and companies wishing to export pharmaceutical products to France will instead be required to use data matrix identification on their products. This includes the new standardized CIP-13 GS1 code, a batch number and the use-by date of the medication.

With a data matrix code, the information is encoded very compactly in a square or rectangular area as a pattern of dots. In comparison to a one-dimensional barcode (1D code), the data matrix code offers a much higher information density per unit of surface area. For example, each code carries a unique number which — according to the new principle of “serialization” — must be stated on the packaging.

Valérie Marchand, responsible for the health sector at GS1 France, explains: “The advantage of this new ruling is that the pharmaceutical companies electronically transfer the data contained in the data matrix code, thus allowing electronic tracking data to be integrated at every stage in the supply chain.” Automating traceability helps to optimize and standardize the tracking of products. This represents a huge advantage for hospitals, which were previously forced to rely on manual administration of the data — a process which did not ensure fault-free traceability.

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