Pharma Serialization in Australia

Pharma Serialization Australia

In March 2021, the Australian Department of Health published the Therapeutic Goods Order (TGO) 106. It recommends that from January 2023 onward certain medicines should be serialized and equipped with a DataMatrix in the GS1 standard, including GTIN. Accordingly, serialization remains optional. However, Australia is taking a further step towards general serialization and will gradually launch […]

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Trends in Pharma 2022/2023

Trends in Pharma 2022

The year 2022 was an eventful one for the pharmaceutical industry. Be it the further introduction of track & trace systems around the world, such as Tatmeen in the United Arab Emirates, or the entry of digital health technologies, such as telemedicine, into everyday practice. In this article, we have summarized the most important developments […]

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Serialization in Lebanon

Serialization Lebanon

Lebanon is in the process of expanding its existing track-and-trace system for the pharmaceutical sector. Since January 1, 2019, it has been mandatory to equip imported pharmaceuticals with a 2D DataMatrix barcode for tracking purposes. As of January 1, 2023, this requirement now also exists for domestic pharmaceuticals. We have summarized the key information on […]

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WBDL – Expert Talk

Warenbegleitende Datenlieferung (WBDL)

Every day hospital pharmacies receive large quantities of pharmaceuticals. These large quantities must also be scanned via securPharm. A more user-friendly solution for this is Delivering Consolidated Shipment Data (German: WBDL). Users of our system for hospital pharmacies have often told us how much the accompanying digital material simplifies the inspection of incoming goods. At […]

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Success Story: Macure Pharma – change of serialization provider

Serialisierungsanbieter

We at tracekey are very happy about the feedback we receive from our customers for our software solutions and support. However, we were particularly excited about hearing the feedback from Macure Pharma. That’s because they took the effort to switch their serialization provider and chose us. Especially for a project as important as serialization, it […]

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Pharma Serialization in Argentina

Pharma Argentina

More and more countries are introducing regulations for the serialization of pharmaceuticals. South America is no exception. With around 422 million inhabitants, the continent has a population similar to the European Union and, with its emerging markets, is developing into an attractive market for exporters. Following our article on serialization in Brazil, here we summarize […]

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Advantages of WBDL in Tender Rounds

Vorteile durch WBDL/Advantages of WBDL

With consolidated shipment data (German: WBDL), hospitals can be relieved of a lot of work. Due to the EU Falsified Medicines Directive (FMD), just like in conventional pharmacies, all packaging of prescription drugs in hospital pharmacies must be scanned twice to guarantee their authenticity. The first time at delivery and then again at dispensing. WBDL […]

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Serialization Simplified – tracekey Serialization Manager

For Marketing Authorization Holders (MAH) and Contract Manufacturers (CMO) in the pharmaceutical industry, serialization is a recurring topic. Each batch must be provided with codes, which must be generated beforehand. For companies with high production frequency and generally more resources, this is usually not a problem. Since it is a regular task, one does not […]

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DSCSA Requirements for 2023

DSCSA Requirements

Beginning November 27th, 2023, FDA’s Drug Supply Chain Security Acts (DSCSA) requirements will change. In the future, pharmaceutical products in the USA will be required to be traceable at the lot and package level.  Moreover, part of the regulation also states that all parties must participate in data exchange, verification, and tracking of pharmaceuticals. For […]

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Cloud and cybersecurity in pharma

Cloud und IT Sicherheit

The cloud has become omnipresent. Whether we are streaming media, communicating with friends and colleagues, or simply storing data. Almost everything is done via cloud providers. But it often sounds like a buzzword to make something more interesting than it actually is. What exactly is the cloud? What types are there? And is it secure? […]

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