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Serialization and traceability: an example of Italian excellence


The European Directive 2011/62/EU will come into force in 2017, ratifying the adoption of a unique community code (UMI: Unique Medicine Identifier) intended for medicines for human use and created with the aim of combatting the widespread phenomenon of counterfeiting in the official distribution circuits. Pharmaceutical companies operating within EU borders are being asked to introduce a system of serialization that enables the origin and integrity of a pharmaceutical product to be controlled at every step of the distribution chain (traceability). The serialization process will be a financial and logistical strain for the company but one that will bring great advantages in the short and long term, leading to a reduction in the costs of managing the stock, the amount of the warehouse inventory and expired products, speeding up the supply chain and allowing Brand Identity to be reinforced, thereby increasing brand loyalty through the concepts of Reliability, Quality and Safety, which are also guaranteed in the phases following production.

 

China E-Code

The problem of counterfeiting, as well as the financial aspect, presents a risk to public health associated with the development of resistance to treatments, illnesses and disabilities, and even deaths; moreover, it undermines the trust of patients in health institutions, health professionals and pharmaceutical companies. Thanks to the measures recently adopted (especially concerning online marketing), the number of cases recorded has fallen slightly but many episodes still occur within the emerging markets of the BRIC countries and their neighbours.

 

 

In an attempt to partially curb this phenomenon, the Chinese government has adopted an E-coding system that consists of a serialized barcode, the EAN 128C code, identifying the manufacturing company, the name of the medicine, the form of dosage and the approval number, each code assigned being unique in compliance with the international standard ISO 15416. The procedure, which began in February 2013, will be concluded in December 2015, completing the traceability process and providing a useful tool for importation in the form of the serialized codes that will enable the management, by product and batch, of the E-codes to be provided by the SFDA (State Food and Drug Administration, the Chinese supervisory body).

Alfa Wassermann Contract Manufacturing was one of the first Italian companies to implement devices capable of ensuring traceability back in January 2014, in accordance with the current regulations, successfully exporting to China. In the coming months, all 9 packaging lines in the Alanno factory will be equipped with flexible systems capable of ensuring compliance with the regulations concerning traceability that will be adopted in the coming years by other EU and non-EU countries. 




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