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 […]
Moving is usually associated with stress. You spend a lot of time planning and carrying out the move and worrying about the transport of your grandma’s fine china. Often, there are high costs involved. However, the move is not without reason. The new home is more beautiful, better situated, and even cheaper. If you can […]
Read More… from White paper: Changing serialization provider | We show you how to do it
Pharmaceutical companies of different sizes face different challenges. However, large companies generally have more financial resources than small companies. Differences arise not only in terms of research and development but also in dealing with regulations. While research and development are usually core areas of pharmaceutical companies, dealing with global regulations is seen as a necessity. […]
The topic of alert management has been on the minds of pharmaceutical companies since the first medicine packs were scanned in a pharmacy in 2019. Especially at the beginning of the implementation of the EU-FMD, alerts were mainly caused by incorrect handling in pharmacies. In the meantime, the system has become established, and the causes […]
The serialization of pharmaceutical products in the MENA countries is becoming increasingly relevant. More and more countries are introducing their own legislation. The term MENA stands for Middle East and North Africa. Countries included are Algeria, Bahrain, Egypt, Iraq, Iran, Israel, Jordan, Kuwait, Lebanon, Libya, Malta, Morocco, Oman, Palestine, Saudi Arabia, Syria, Tunisia, and the […]