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 […]
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 […]
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 […]
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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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. […]
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 […]
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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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 […]
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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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, the subsidiaries are 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 […]