The turn of the year reminds us to look back at the steps taken by the Latvian Medicines Verification Organisation (LZVO) and other members of the European Medicines Verification Organisation (EMVO) throughout this year. Next year, the ecosystem of national medicines verification organisations will undergo a change in membership, while the Latvian Medicines Verification System will see improvements in processes that have already started to be reviewed this year.
This February marked the fifth anniversary of the medicines verification system in Europe and Latvia. By 2025, 31 countries will be working together to protect Europe's citizens from counterfeit medicines, making sure patients only receive authentic and safe medicines.
Improving the technical quality of the system
This year, the new version 5.0 of the Latvian Medicines Verification System was introduced to provide the nearly 1200 system users in Latvia with an easy-to-use and efficient solution. The system's interface has been improved and the LZVO website has been updated with explanations and recommended actions when users encounter system notifications and alerts, as well as information on how alerts are investigated.
It has been announced that next year the LZVO will start the ISO certification process to meet international Quality management system (ISO 9001) and Information security management system (ISO 27001) standards. Information gathering on the current processes has already started in order to verify their compliance with the standards defined by the International Organisation for Standardisation and to plan the necessary improvements to make the system even more secure and reliable for all its users.
Developments in the European system: news from Northern Ireland, Greece and Italy
On 31 December 2024, Northern Ireland will be disconnected from the EU medicines verification system, resulting in the permanent deletion of all related data on medicine packages and verification transactions. From 1 January 2025, new labelling rules will apply throughout the UK, including Northern Ireland. Prescription medicines will have to be labelled "UK Only" and will not be allowed on the EU market.
Meanwhile, the transition period for Greece and Italy to fully join the EU medicines verification system will end on 9 February 2025. Greece and Italy are currently redesigning their labelling system to move to the EU unique identifier. The national medicines verification organisations of both countries are working closely with the European Commission to ensure successful integration.
This year, the LZVO has actively engaged with partners in the Baltic and Nordic countries, sharing updates from colleagues in Lithuania, Estonia, Sweden and Finland. We will start 2025 sharing a story about the experience of the Romanian Medicines Verification Organisation.
Fewer cases of counterfeiting, but vigilance remains high
Earlier this year, the European Commission published an evaluation of the functioning of the EU Falsified Medicines Directive 2011/62/EU. The evaluation confirms the effectiveness of the system: the number of counterfeit cases in Europe has decreased from 24 (in 2017) to 3 (in 2022). Counterfeits are mainly spread on the illicit market, particularly affecting expensive and lifestyle medicines.
So far, no cases of counterfeit medicines have been detected in Latvia, but high vigilance is maintained to follow global trends, such as the rapid spread of counterfeits of the type 2 diabetes drug Ozempic. The performance of the system in the last quarter of the year will be presented in the January newsletter.
The LZVO will continue to focus on improving the system together with the partners involved to ensure the highest safety and quality standards in Latvia and Europe. Thank you for your cooperation this year and we look forward to strengthening it next year!