Globalization and national efforts to make medicines safer and exclude counterfeits from the legal supply chain present significant challenges for pharmaceutical manufacturers. They must comply with numerous different pharmaceutical regulations depending on how many markets they supply their products to. To counteract this, there are global efforts to standardize regulations and standards in the pharmaceutical industry. […]
The Vietnamese pharmaceutical market has recently experienced strong growth. According to current forecasts, the market is expected to reach a turnover of around USD 2.4 billion in 2024. Furthermore, an average annual growth rate of 4.25 % is expected until 2029. Growth will be boosted by factors such as an ageing population, rising healthcare expenditure […]
A package insert is an information sheet that accompanies medicines. It contains important information such as the name, active ingredient, dosage, and instructions for use. Possible side effects, contraindications, and interactions with other medications are also listed. Leaflets are of great significance to read before taking medicine to ensure it is used safely and effectively. […]
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 […]
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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 […]