There are many reasons for marketing authorization holders (MAH) or contract manufacturers (CMO) to inevitably deal with serialization during ongoing operations. May it be to increase production capacity, to connect to a new business partner or any other of many possible reasons. These new conditions can raise some questions. Do I simply increase capacity with […]
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 […]
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 […]
Read More… from Case Study: Stegemann (CPO) together with Level 3 partner Mettler Toledo
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 […]
Read More… from Counterfeiting? Medical Product Alerts in the securPharm System
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, […]
Read More… from Pharma Serialization Regulations of the UAE: Abu Dhabi