The U.S. Food and Drug Administration (FDA) has unveiled a significant development in pharmaceutical compliance with the immediate implementation of new guidelines. This guidance, titled "Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act – Compliance Policies," outlines...
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CPHI 2023 will take place in Barcelona during the last week of October. We are delighted to announce that our team is going to present the world’s largest pharmaceutical exhibition for another year in a row. Whether you’re looking for your next business partner or you want...
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Dietary supplements are products containing concentrated sources of nutrients or other substances such as vitamins, minerals, products of animal origin, amino acids, metabolites, etc. The definition of these products is different according to the country. In China they are called Health food, in the EU –...
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In this article we will give some clarifications on the use of global vs national standards for the codification of medicinal products to implement the EU Falsified Medicine Directive (EU FMD) in France. Background In 2019, GS1 adopted rules for ensuring unique identification and integrity in its...
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Discover the requirements and deadlines for Uzbekistan, Kazakhstan and Kyrgyzstan. Download the whitepaper now by filling in the fields below: [contact-form-7 id="266e083" title="Contact form - CIS whitepaper"]...
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A GTIN number in the pharma industry is like a product barcode, used for tracking and identification. It's a unique code assigned to each medicine or package to help manage the supply chain. In this second article dedicated to GS1 Standards, we will give you valuable...
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In the beginning of October in a 3-day event will take place the 38th GS1 Healthcare Global Conference. We are proud to announce that SoftGroup is an official sponsor of the GS1 Healthcare Global Conference for the third year in a row. This year the focus...
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In July 2023 the Republic of Kazakhstan announced a comprehensive strategy for introducing labeling and traceability of medicines. The aim is to enhance transparency, accountability, and efficiency in the pharmaceutical sector. The plan uses a series of organized actions, including changing rules, sharing data, and giving...
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The pharmaceutical industry's journey toward sustainability involves implementing practices and strategies that minimize its environmental impact while continuing to advance medical science and patient care. Recognizing the importance of sustainability, many pharmaceutical companies are now striving to strike a balance between their business objectives and their...
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Global standards such as GS1 are essential for the efficiency of healthcare systems. They are important for improving patient safety and well-being. The power of standardization and the benefits of efficient data exchange is doubtless. The fundamental concept driving GS1 standards is to facilitate transparency within...
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In July 2023, the Minister of Economy and Commerce in Libya issued Decision No. 379 of 2023 requiring the application of a GS1 DataMatrix on pharmaceutical products and medical equipment supplied to the Libyan market. The path of barcoding of pharmaceuticals and medical devices Decision No. 379...
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Introducing the second article of the series on Africa's Track and Trace Compliance landscape. In this paper we will look through the Track and trace systems in Zambia, Botswana and South Africa. Zambia In late October 2021, the Zambia Medicines Regulatory Authority (ZAMRA) published a draft Guideline...
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JFDA extended the implementation deadline for DataMatrix and serialization on secondary packaging on regulated pharmaceutical products until 30 September 2023. Journey towards traceability implementation Jordan announced the implementation of pharma serialization in 2017. The first phase included a transition period during which 2D DataMatrix codes were allowed...
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The Indonesian Food and Drug Monitoring Agency (BPOM) has launched an initiative called the e-Labeling Pilot Project which certainly will make a significant impact in the healthcare industry. Current labelling and packaging regulations Pharmaceutical products must comply with specific labelling and packaging requirements, including information on indications,...
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In May 2023 Medical Device Coordination Group (MDCG) approved new changes to the design or intended purpose of medical devices. Some of them are considered significant while others are non-significant. Products with certificates issued under the old EU directives can stay on the market during...
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29th June 2023 At the beginning of 2023, SoftGroup put the start of the joint contest “We Build our Future Together” with ACS. The winning project is designed by Julia Dobreva and Iva Ivanova, Class of 2024, in American College Sofia. In the last 2 months,...
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This year SoftGroup was a General Sponsor of the International Congress and Exhibition Pharma Kazakhstan & Central Asia 2023 that took place in Astana, Kazakhstan on the 13th and 14th of June. SoftGroup was represented by Venelin Dimitrov – CEO, Andrey Atanasov – CRO/ Director Business...
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Uzbekistan, Kazakhstan, and Kyrgyzstan – CIS region countries focused on pharma modernization and traceability enhancement In the last two years, the Pharma industry in the CIS region is undergoing a transformation. Countries such as Uzbekistan, Kazakhstan, and Kyrgyzstan have put a great effort and strategic actions...
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14th June 2023 The second Sustainability report for 2021-2022 shows SoftGroup commitment to responsible development SoftGroup announced its second edition of the Sustainability report for 2021-2022 The company is a leader in the Pharma industry in the CEE region. It provides a complete cycle of Track and Trace...
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31st May 2023 SoftGroup marked its 20th anniversary, gathering together clients, partners, and stakeholders. Sofia, Bulgaria, May 31st, 2023 – SoftGroup, the best-in-class end-to-end traceability technology provider in the CEE region, marked its 20th anniversary, gathering together clients, partners, and stakeholders. At a business cocktail, we had the...
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