Pharma Serialization in China

Pharma Serialisierung in China

As the country with the largest population, China also has one of the largest pharmaceutical markets in the world. In 2020 nearly 35 billion U.S. dollars were generated in pharmaceutical imports, and the trend is upward. In order to counteract counterfeiting and protect patients, the regulations of pharma serialization in China were adjusted in the […]

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Case Study: Stegemann (CPO) together with Level 3 partner Mettler Toledo

How does the cooperation between tracekey and the Level 1-3 providers work? We talked to one of our customers, Stegemann Lohnverpackung & Logistischer Service e.K. and the line manufacturer and Level 3 provider Mettler Toledo about our joint processes and work. The complete implementation of pharmaceutical serialization requirements, such as the EU FDM, includes not […]

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FAQ on pharmaceutical serialization

Efforts are being made worldwide to stop the dangerous trade of counterfeit medicines. To tackle this problem pharmaceutical serialization laws have now been enacted in numerous regions all over the world. Depending on the statutory requirement, serialization in the pharmaceutical industry is enforced differently. What all regulations have in common is the assignment of a […]

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What is the advantage of active alert management for me as a pharmaceutical company?

EMVO AMS, Alert Management for Pharma

Alert Management & EMVO AMS | Alerts keep the industry busy – ever since the start of the active commissioning of the serialization activity. The system, which is supposed to protect patients from counterfeit medicines, produces many error messages from the very beginning when verifying medicines in the pharmacy. These are almost exclusively false positive […]

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Counterfeiting? Medical Product Alerts in the securPharm System

Alerts in securPharm, NMVS, EMVO

Alerts in securPharm and EMVS Approximately two years after the EU-wide Falsified Medicines Directive (FMD) came into force, many false-positive alerts make it difficult to find actual falsifications. Both, the national systems (NMVS) and the EMVS are working on reducing these alerts. Although the number of false alerts in the European anti-counterfeiting systems has decreased […]

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Track-and-Trace in Saudi Arabia

In Saudi Arabia, work has been underway since 2015 to make medicines safer and prevent counterfeiting through serialization. Unlike in Europe (end-to-end), a complete track-and-trace system will be introduced. Designation: Drug Track and Trace System for Pharmaceutical Products (RSD) Competent authority: Saudi Food and Drug Authority (SFDA) Products: All medicines for humans and animals Code […]

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Pharma Serialization Regulations of the UAE: Abu Dhabi

Abu Dhabi track and trace pharma

In Abu Dhabi, medicines must be serialized since the beginning of 2022. The Arab Emirates (UAE) are gradually implementing pharma serialization regulations. Competent authority: Ministry of Health and Prevention (MoHaP), UAE Products: all pharmaceutical products listed with the Department for Health as approved drugs Code type: GS1 Data Matrix Aggregation: Required starting January 2023 Despite cooperation on this point, […]

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Pharma Serialization in Brazil

As one of the biggest economies in Latin America, Brazil is joining numerous other countries to mandate serialization in its pharmaceutical supply chain. The implementation of the regulations ensures the tracking of every event along the supply chain, where all supply chain members must be involved in the entire process. Also, these sets of requirements […]

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