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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The Six EUDAMED Modules (MDR)

Overview of the 6 EUDAMED modules (MDR)

An important component of the MDR and IVDR is the EUDAMED. As a central database, it is intended to create more transparency, bundle information, and serve as an exchange and reporting platform for the individual actors. To this end, it consists of six modules that cover various topics ranging from the registration of medical devices […]

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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 tracekey Community Cloud

tracekey community cloud plus connected world

What the Big Ones Can Learn from Us Our corporate strategy is based on three pillars. The consistent operation of our solutions in the cloud, a modern and flexible software architecture, and agile organizational and development processes. As a full-service solution, we offer our customers from the SME segment what they need. A sustainable, future-proof, […]

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tracekey as an agile company

Since 2013 we work in agil teams.

How Scrum and Co. help us to use our resources effectively Global compliance is essential for the pharmaceutical industry. Therefore, companies need serialization providers, whose offer covers all requirements on a global level, to implement the numerous regulations. As an agile company, tracekey can ensure this offer with significantly fewer resources as many larger software […]

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Cloud Technology: The Advantages of SaaS

We┬┤re using a cloud plus SaaS solution for pharma serialization at tracekey solutions

Cloud technology is used mostly for digital services and software. Especially where the IT infrastructure must always be available, accessible, and in all places. In the meantime, using a cloud has become part of everyday life for many people, whether privately or as part of their work. SaaS applications are particularly relevant in the B2B […]

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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 coming 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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WBDL: How Does mytracekey HospitalDirect Differ from Other Solutions?

WBDL: Was macht HospitalDirect besser?

Consolidated shipment data can be implemented in different ways. This is partly since there are no comprehensive standardsthat providers have to comply with. How does the cloud platform mytracekey HospitalDirect differ from other possible solutions for offering digital data delivery? There are different approaches for the offer of consolidated shipment data (German: WBDL). In general, […]

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