The Medical Device Regulation (MDR) is an EU directive that will come into force on 26 May 2020 and represents a further large-scale revolution in industry. In addition to some reclassifications and high demands on data management, Unique Device Identifiers (UDI) on medical devices will also become mandatory. UDI labelling was introduced in the USA […]
The implementation of EU-FMD is not the only track&trace initiative to protect against counterfeit medicines. […]
If you think of business software, the well-known names of large software manufacturers come to mind […]
In pharmacies hundreds of medicines are sold everyday. From 9 February 2019, all prescription drugs must be serialized. So what does the Falsified Medicines Directive (FMD) mean for pharmacies and their internal processes? Pharmacies usually purchase their medicines from wholesalers, where individual packagings can be checked optional. In the pharmacy every single medicine pack is […]
Hospitals work with a large number of Rx drugs on a daily basis, in addition processes are closely timed. So how will the Falsified Medicines Directive affect hospital pharmacies? The Falsified Medicines Directive (FMD) stipulates that every prescription-only drug in hospital pharmacies must be scanned and verified via the database. The Bundesverband Deutscher Krankenhausapotheken (ADKA), […]
Traceability and a transparent supply chain play a key role in many industries. The key questions amongst all are the provenance and pedigree of a product as well as providing a secure and traceable path from the producer to the consumer. The pharmaceutical industry tries to summarize these questions under the keyword “serialization”. In the […]
The primary objective of serialization is to protect patients. This is ensured by processes and control mechanisms that ensure that only original and manufacturer-approved drugs reach pharmacies and hospitals. Sustainable changes in almost all areas Manufacturers, contract manufacturers, wholesalers, repackagers, parallel importers – or in other words: the entire pharmaceutical industry need to invest in […]
In Germany’s “deep West”, the Ruhrgebiet, honest work has always been part of the DNA. What used to be coal and steel are now innovations and the people who implement them. With over 5.1 million people in more than 50 municipal communities, the Ruhr area is the largest metropolitan region in Germany and one of […]
With its cloud-based solution, tracekey is one of the leading level 4/5 providers among the serialization systems. The International Society of Automation (ISA) categorizes IT systems into five levels based on their role in the production process. This has also become the standard wording in the description of serialization systems. The lowest level (Level 1) […]
With the publication of the delegated Regulation (EU) 2016/161 in the Official Journal of the European Union, the deadline for transposition of the new EU Counterfeiting Directive has been set. Beginning on 9.2.2019, prescription drugs must be clearly identifiable and traceable – every single package. Increasing drug safety for consumers Antibiotics, anticancer and antimalarial drugs, […]