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On October 18th, 2018 international conference “Industry 4.0: Advanced Solutions for the Pharmaceutical Manufacture, Technology and Packaging” was held. The conference was attended by technical experts of Ukrainian pharmaceutical companies, manufacturers of the equipment and suppliers of solutions for the pharmaceutical industry. The event was aimed at familiarizing technical professionals with possible solutions offered by Ukrainian and international suppliers, and considering the regulatory norms, including export legislation, taking into consideration requirements of compulsory marking with the identifier, which come into force in the EU in February 2019.
Illya Kostin, partner at Legal Alliance Company, acted as an independent expert in the session Track&Trace devoted to issues of marking with the individual code, serialization and tracking of medicines in the supply chain, and paid attention to the application of Order of the Ministry of Economic Development and Trade of Ukraine “On Approval of Definitions of the Main SI Units, Names and Definitions of Derivative SI Units, Decimal Multiples and Partial from SI Units, Permitted Non-System Units, and their Notations, and the Rules of Application of Units of Measurement and Writing of Names and Symbols of Measurement Units and Character Values” No. 914 as of August 4th, 2015, the Law of Ukraine “On Metrology and Metrological Activity” and the effective legislation regulating the circulation and registration of medicines.
“Currently, the procedure for fulfilment of Order No. 914 remains important. Control in the area of SI system application was vested with the State Service of Ukraine for Safety for Food Products and Consumer Protection, however, there is no mechanism of its application with respect to medicines. Therefore, these issues must be agreed upon between the state authorities, and if the State Service of Ukraine for Safety of Food Products and Consumer Protection somehow will decide to start controlling circulation of medicines and applying sanctions, the market subjects will have a chance to win the dispute in court”, Illya Kostin underlined.
Contact the speaker: Illya Kostin, partner at Legal Alliance Company, kostin@l-a.com.ua.
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