Our non-customers also benefit from our expertise. We don’t keep our knowledge to ourselves. Instead, we regularly provide updates on regulations and share our accumulated knowledge on pharma serialization in our pharma articles.
Our regulatory updates are of particular interest. That´s no surprise, since that’s exactly where our customers need to stay up to date. There, we present news or changes to the serialization requirements of individual countries. Due to their current relevance, we would like to highlight the information on the Italian Bollino and Italian EU FMD compliance. Additionally, the importance of serialization and the protection of legal supply chains against counterfeit medicines was recently demonstrated by a case in the USA, and will be discussed here. We would also like to talk about pharmacovigilance and developments in PubMed.
Regulatory updates for pharma serialization
There have been many updates on the Italian pharma serialization since the beginning of the year. Following the announcement of the two-year transition period for the use of Bollino, it was also announced that there will be a transitional Bollino. It will be viable during these two years, before another new version has to be used from February 2027. According to GS1 Italy, from this point onwards, serialization following the EU FMD will be used to identify medicines, and the new Bollino will be used to protect them against counterfeiting. Learn more about the path to implementing the EU FMD in Italy and the Bollino system by reading our article on the subject.
Anti-counterfeiting technologies
In April 2025, it was reported that several hundred units of counterfeit Ozempic® (semaglutide) were circulating in the US. The counterfeits entered the market outside of the manufacturer’s authorized supply chain. It was also announced that the packaging had an authentic batch number, but the serialization codes were not authentic. Thanks to serialization, the counterfeit products can be identified and withdrawn from circulation. It is not known which active ingredient the counterfeits actually contain. Accordingly, they pose a major health risk to the public.
Serialization is just one of numerous anti-counterfeiting technologies that are used worldwide to secure supply chains. You can find out more about which additional technologies are being used in one of our articles on the topic. It also provides insights into what these technologies might look like and how supply chain protection laws can help.
Pharmacovigilance
PubMed and Pharmacovigilance are closely linked, as PubMed is an important resource for drug safety research and monitoring. Pharmacovigilance is concerned with the detection, assessment, understanding, and prevention of adverse drug reactions or other drug-related problems.
In the wake of the change of government in the USA, some health experts have expressed concern about the future of PubMed. This was also the case in an article on MedPage Today. The Biden administration introduced a policy in 2022 that requires all taxpayer-funded research to be publicly accessible by 2025. Under the current administration, which has frozen NIH (National Institutes of Health) funding, this could be jeopardized. The result would be a decline in published research.
PubMed is a database that contains scientific articles and studies in the field of medicine and life sciences. It is maintained by the United States National Library of Medicine and the NIH. Researchers and pharmacovigilance professionals use PubMed to find current studies and reports on adverse drug reactions, drug interactions, and other safety-related information.
PubMed also plays an important role in the indexing of journals and protects against fraudulent publications. Due to financial and staffing cuts, there are further concerns that the current administration could make PubMed inaccessible, stop updating it, or change the indexing system.
Planning security for pharmaceutical companies
The example of PubMed, together with the uncertain situation regarding future tariff increases by the US, creates many uncertainties for companies worldwide. Price increases and trade restrictions have an impact on supply chains and can impair competitiveness. Companies will therefore increasingly rely on partners and service providers in Europe, as they can offer better planning security.
Are you looking for a reliable serialization partner in the EU? Get in touch with us or book a demo.