Despite the harmonization efforts of the European Falsified Medicines Directive, pharmaceutical regulations in the European Union remain fragmented. Belgium, France, Greece and Italy, for example, each have a national solution for the labeling of medicinal products that differ from those in other EU countries. A company manufacturing for Spain needs a lot more effort to […]
Read More… from Parallel Distribution in the Pharma Industry
Track & Trace systems aim to trace counterfeit medicines. In many parts of the world, this procedure is already common practice, for example in the EU or the USA. The TRVST system is an initiative of UNICEF and others and is intended to restrict the trade in counterfeit and substandard medicines in the long term, […]
Products, as we buy them in the store, are usually available in cardboard boxes, plastic film, cans, or bottles. Here we are talking about primary packaging. It is the packaging that directly surrounds the product. For easier transportation, primary packaging is combined in larger packaging, for example in a wine crate. This level is called […]
Switching serialization providers raises many questions. We have already compiled numerous answers to the various concerns that could be associated with a change in another white paper: “Changing serialization provider | We show you how”. We delve deeper into the topic in our latest white paper: “Changing serialization provider – switch to tracekey in five […]
Kazakhstan has been planning the mandatory labeling of goods since 2016, initially for tobacco products and shoes. This was followed in 2018 by plans to implement mandatory labeling of pharmaceuticals. The corresponding Regulation No. KR DSM-11 was adopted on January 27, 2021. The Central Asian country planned to launch the labeling project on July 1, […]
The European Falsified Medicines Directive (EU FMD) came into force on February 9, 2019. For many pharmaceutical companies, this was the first step towards serialization and often required a rapid introduction of digital processes. The situation was different in Italy, Greece, and Belgium. Systems for verifying and tracing medicinal products have been in place here for some […]
Have you ever struggled to find the information you need in a leaflet? Perhaps you’ve even given up on using it because you couldn’t fold it back up correctly. A better solution would be to access the instructions for your medication on your smartphone. This would save you time and frustration. If you are familiar […]
With the go-live of the EU-FMD and the first scans in pharmacies, high numbers of error messages did arrive. Analyzing these alerts and reporting them back to the EMVO is the responsibility of the pharmaceutical manufacturers (MAH) and the national authorities. However, for a long time, the authorities and the MAHs ignored the error reports. […]
Read More… from Alert management in the EU-FMD: responsibility of the MAH
The EMVO Alert Management Portal (EAMS) has been in place since the beginning of 2023. The new portal has changed a lot for everyone involved. Previously, the processing of alerts was not prioritized by either the NMVOs or the pharmaceutical companies. There was simply a lack of options for analyzing large volumes of alerts and […]
Read More… from EAMS Overview: Basic Info on Alert Management
On February 9, 2025, the last three EU member states should have introduced the European pharmaceutical serialization system. The European Falsified Medicines Directive (EU-FMD) came into force on February 9, 2019. However, Italy, Belgium, and Greece were granted a six-year exemption, as these countries already had existing systems for verifying and tracing medicinal products. In […]