Regulatory authorities have defined (or are in the process of defining) requirements for the serialization for pharmaceutical products and tamper evidence, in an effort to address falsified medicines and reimbursement frauds. The implementation plan and specific requirements may vary for each market. For the majority of the markets (including EU), the new regulation is expected to be effective by 2018, according to the latest EU announcement.
FAMAR is preparing on time, for the new regulatory requirements and has put in place since 2013 a global cross-functional team (Engineering, Information Systems, Quality & Supply Chain) to manage the project. We are making a significant investment in our packaging operations and Information Systems infrastructure to support serialization requirements.
In the coming years, the new technology will be deployed on most of our packaging lines across all our sites. In January 2015, we completed successfully the production of the 1st serialized batch for the Korean market, in our manufacturing site in St-Remy, following the close cooperation with our customers and suppliers. Our objective is to implement a cost effective, high quality and flexible solution and transform this challenge to an opportunity which will increase the benefit to our customers.