Indonesia: Pharma Serialization Regulations

Phama Serialization Requirements Indonesia

Indonesia has been working on pharma serialization regulations and their implementation since 2017. By 2025, all prescription drugs must be serialized and equipped with a 2D data matrix code. A QR code requirement for OTC and processed foods, among others, will apply as early as 2023. Title: BPOM Regulation #33/2018 Implementation of 2D barcode in […]

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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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Global Compliance: Russia | Success Story

Success Story: Dolorgiet/Dr. Theiss Naturwaren are working with tracekey for Russia Serialization

Pinpoint Landing with Ibuprofen Manufacturer Dolorgiet Product: mytrackey PHARMA The Challenge Russia has become an important export country for Dr. Theiss Naturwaren GmbH in recent years. The company Dolorgiet, which is part of the Dr. Theiss Group since 2016, has been selling its product range not only in Germany but also in Russia since 2008. […]

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Track-and-trace in Saudi Arabia

Serialization in Saudi Arabia track and trace system

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 is to being introduced here. Designation: Drug Track and Trace System for Pharmaceutical Products (RSD) Competent authority: Saudi Food and Drug Authority (SFDA) Products: All medicines for humans and […]

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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 from mid-2021. 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 September 2021 Timeframe: July 2020 to […]

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Brazil Pharmaceutical Serialization Regulations

Track-and-trace in Brazil

The regulations for pharmaceutical serialization in Brazil are implemented in three stages. They provide for the tracking of every event along the supply chain. It makes Brazilian legislation much more complex to implement than, for example, European legislation, as all participants in a supply chain must be involved in the process.  Designation: SNCM (National Medicine […]

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The Brexit Impact on Pharma + MedTech Industry

What impact has the Brexit on the Pharma and MedTech Industry?

It has taken four years for the British to finally leave after their referendum against remaining in the European Union. Despite the last-minute trade deal, the impact of the Brexit on the Pharma and Medtech industries is huge, and they are left with only a little concrete information.  In 2016, just over half of the […]

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Global Compliance in the Pharmaceutical Industry

Global Compliance in der Pharmaindustrie mit tracekey

Counterfeit medicines have long been a topic with global implications, which countries are countering with legal regulations, among other things. Raw materials come from China or India, there are subsidiaries in Europe and the USA, and the drugs are distributed worldwide. Due to the global networking of the pharmaceutical industry, internationally active companies must comply […]

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How digitalization contributes to more quality

Digitizing Quality Management

| Our student trainees Software development and cloud computing require continuous development to steadily improve current operating principles. A significant job in this regard is done by our student trainees, who intensively work on projects that show us new technologies and approaches. Lynne has been working for tracekey as a student trainee since the end of […]

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