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Project

In "Italfarmaco" launched a system of labeling dietary supplements

Customers: ITF (Italfarmaco)

Moscow; Pharmaceutics, medicine, health care

Contractors: Utrace, Navicon
Product: Utrace Hub

Project date: 2019/09  - 2023/06

2023: Launch of the dietary supplement labeling management system

Utrace On July 5, 2023, the company announced the launch of a dietary supplement labeling management system in Italfarmaco"." With the help Utrace Hub pharmaceutical of, the company can transmit reports on the movement of products in. state system of GIS MT accounting This will allow it to comply with the requirements of legislation in the field of ensuring traceability of goods.

In 2023, mandatory labeling of dietary supplements is introduced on the territory of Russia. According to the requirements of the law, pharmaceutical manufacturers, importers and sellers must transfer all information about such products to the state system for monitoring goods (GIS MT). This will avoid counterfeiting when selling biologically active additives and displace illegal products from the market.

Understanding the need to work on the introduced rules, the company began early preparation for the transition to digital labeling. Previously, the company has already introduced the Utrace HUB cloud track & trace system for managing drug serialization. The current Utrace HUB loop has been expanded with functionality for dietary supplements.

With the help of the implemented solution, ITF LLC will be able to order over a million codes annually, which will fully provide all the production facilities of the pharmaceutical company.

As part of the project, Utrace specialists deployed the necessary functionality, configured Utrace HUB integration with the RUFE WMS system and the ERP development ERP system '1C'. In addition, the vendor team provided validation of the resulting GMP solution. As a result, the customer received a stable track & trace solution independent of foreign suppliers.

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Utrace is an experienced developer with a strong expertise in the pharmaceutical industry. Colleagues understand the requirements of the industry and are ready to quickly adapt their product to all legislative changes. The Utrace team helped us launch the labeling of dietary supplements quite quickly, and by the "high season" - autumn-winter of 2023 - we will be able to fully work under the conditions introduced, "said Alina Klimkina, project manager at ITF LLC.
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The transition to mandatory labeling of dietary supplements began back in 2021, when the state regulator launched an experiment. In October 2023, it will become mandatory, and by 2025 the market is waiting for piece-by-piece accounting of products. Despite the fact that this process will take some time, we recommend preparing for it now. It is important to configure and test the process before labeling becomes mandatory for all dietary supplement manufacturers, "said Vasily Savin, director of consulting at Utrace.
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2022: Implementation of Track & Trace system for serialization of dietary supplements

ITF, the Russian division of Italfarmaco, has launched a project to introduce a Track & Trace system for serializing dietary supplements. This is one of the first initiatives on the market to switch to the labeling of dietary supplements. This was announced by ITF on April 21, 2022.

The Russian division of Italfarmaco is engaged in the promotion of women's health products, assisted reproductive technologies, as well as problem solving. osteoporosis

The L4 Utrace Hub cloud solution for serialization of medicines has been introduced in ITF. During the project, Utrace Hub was also integrated with the 3PL WMS system of the ORFE operator, the 1C ERP solution and the global Track & Trace system in Italfarmaco. As of April 22, 2022, Utrace Hub automatically processes data on goods and sends messages to the IS MDLP in full compliance with the current requirements of the law.

As part of the development of the project, it was decided to connect the labeling of dietary supplements to the current Utrace Hub circuit. The experiment on the labeling of dietary supplements started in August 2021 and will last until February 28, 2023. Products that have a certificate of state registration fall under its effect. Thus, thanks to Data Matrix codes, buyers will be able to verify the authenticity of products and distinguish dietary supplements from food industry products masquerading as them. After the end of the experiment, serialization of biologically active additives will become mandatory.

Utrace plans to deploy a dietary supplement labeling system for ITFs by September 2022. During the project, integration with the current IT landscape of the company will be configured, as well as preparation for validation according to the GAMP 5 standard.

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The process of choosing a partner was influenced by our previous experience with Utrace: the Track & Trace implementation project for the drug system was implemented in just 7.5 months, and the solution in 2021-2022 works without failures and problems. In addition, the Utrace Hub can be quickly scaled to updated product categories and set up all the necessary integrations. Therefore, we decided to continue our cooperation,
commented Alina Klimkina, logistics manager of ITF.
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Those companies that begin preparation in advance and have time to debug all processes before the start of mandatory labeling will be able to quickly and painlessly adapt the business to the updated requirements of the legislation,
comments Konstantin Ivanov, CEO of Utrace.
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2020: Implementation of an Integrated Product Labeling Management Solution

On June 9, 2020, Utrace announced the completion of the implementation of a cloud solution for integrated product labeling management L4 Utrace Hub in ITF LLC (Russian division of Italfarmaco). The launch of the first batches is expected in September 2020, the system is fully ready for their processing and sending messages to the IS MDLP.

Like other pharmaceutical companies operating on the territory, RUSSIAN FEDERATION ITF LLC needed to introduce a serialization system that met the requirements of Russian law. The L4 Utrace Hub system was chosen, which allows pharmaceutical companies to comprehensively manage. marking The developer of the solution, Utrace, implemented the project together with the partner for the implementation of serialization systems -. system integrator Navicon

The project at ITF LLC started in September 2019. In just 7.5 months, the development team implemented the Utrace Hub system, conducted acceptance testing and processing of test batches in pilot operation mode. Utrace also integrated the solution with the 3PL WMS system of the ORFE operator, the 1C ERP system and the Tracelink global Track & Trace system: the work was carried out jointly with the contractors on the part of the customer. At the same time, the source noted that Utrace had previously established interaction with all of the above systems in other projects, as a result of which integration was implemented quickly and with a minimum amount of development.

Finally, for the subsequent validation of the marking system, the development team has prepared the necessary documentation for the GAMP 5 standard.

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We wanted to implement a labeling project with minimal involvement of our employees. To do this, you had to find a reliable partner with a qualified team to rely on. We chose Utrace: thanks to the technical and business expertise accumulated by its employees, the labeling system was introduced on time and in compliance with all the requirements of the law, - commented Alina Klimkina, project manager, ITF LLC.
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The Utrace Hub system is fully ready to process and send messages to the IS of the MDLP. We expect the readiness of the production lines of ITF LLC and support the decision on the cloud subscription agreement. The launch of the first batches is scheduled for early autumn, "added Konstantin Ivanov, CEO of Utrace.
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