Three dates for your EU-FMD 2025 calendar

As we are approaching the end of the year 2023, it is time to look towards not 2024 but the year 2025, which will bring in several notable changes to the EU-Falsified Medicines Directive (FMD) systems and processes that will require the attention of all Marketing Authorisation Holders (MAHs) selling medicines in Europe.

The first change on 1st January 2025 is the end of the current UK post-Brexit transitional arrangements. From that date the EU-FMD no longer applies to Northern Ireland, the last part of the UK that was still in scope of the EU-FMD. This change should come as no surprise to anyone but just as a reminder, here are the main implications for MAHs: From 2025 it will no longer be possible to combine the UK pack with any other EU market; UK packs can therefore no longer be supplied to the markets that have historically received UK packs, in particular the Republic of Ireland, Malta and Cyprus. However, this does not mean that MAHs need to stop serialising UK packs: The guidelines issued by the MHRA on 28th July 2023 make it clear that voluntary application of the EU Safety Features - the 4-element 2D barcode and the Anti-Tamper Device - will be permitted on UK packs after 1st January 2025. It is, in fact, the Excellis recommendation to continue serialising and retain these SNs without uploading them to the EU Hub, for three main reasons:

• Serialisation is generally seen as beneficial for MAH internal purposes (Product Security, Traceability)
• The presence of a 2D DM will encourage scanning by end-users in the EU which would generate an alert should such a UK pack end up in Europe after all, which it would give MAHs visibility of potentially undesirable product flows. 
• Readiness for the anticipated, eventual UK product tracing requirement (even if there is currently no UK repository and no details or timeline as to when this will come about).

The next big date is 9th February 2025 when the obligations to comply with the EU-FMD comes into force for both Italy and Greece, the two markets with a 6-year derogation due to the pre-existing serialised labels (Bollino and EOF label). The big question that is being asked is, of course is: Will it happen? A good question, indeed, as updates provided at EMVO's recent EU-FMD workshop or by the latest minutes of the EC Expert Group on the Delegated Act on Safety Features do not "provide a warm feeling".

In Greece negotiations between stakeholders still need to be completed to allow for the founding of the National Medicines Verification Organisation (NMVO), the first step in a process that will lead to the selection of the National Medicines Verification System (NMVS) system provider, to the establishment of the system and processes and include the readiness to on-board all On-Boarding Partners (OBPs) i.e. the MAHs that supply medicines subject to the EU-FMD to Greece. 15 months seems a highly challenging timeline to achieve this, based on the experience in other markets. Even if there are well-established templates and two NMVS blueprint systems available, setting up such a complex and interdependent system is not a case of simply plug and play. Other areas where there seems little discussion in Greece, at least so far, is how to handle the transition from the existing label infrastructure and processes to the FMD Unique Identifier (UI), how to manage any data migration or integration for shared packs, particularly with Cyprus where the EU-FMD obligations came into force back in 2019. 

The situation in Italy presents as equally if not more challenging than in Greece: While there have been more discussions and even detailed proposals on how to manage the transition from the current Bollino system to the EMVS, many more questions remain, including:

• the scope of products (all reimbursed medicines under the current system rather than just prescription drugs), 
• the thorny issue of money (remember that the bollini stickers have to be purchased from the national mint) and
• governance and data access, because the current government-operated system (NSIS) provides much more information to the Italian authorities about the national medicines supply chain than will be available under the provisions of the FMD Directive. 

It is therefore likely that at least part of the current system infrastructure will continue to exist with some form of integration alongside the future Italian NMVS. This means that Italy will not be implementing an out-of-the box blueprint system but a bespoke solution which will bring additional complexity, cost and, of course, impact the implementation timeline. A draft plan that Italy has provided to the European Commission foresees an extended "interoperability phase” until 2028 followed by a transitional period until 2033 when all medicines on the market carrying a bollino would have reached the end of their shelf life. 

For MAHs, the situation regarding both markets remains therefore deeply unsatisfactory, with a lack of details regarding the implementation steps, the milestone dates, and indeed, the certainty of the 9th of February 2025 date which is by now getting uncomfortably close to realistic readiness, implementation and soon even production planning timelines.

The final date that MAHs should mark in their calendar is Q3 2025: This is the time when the EU-FMD requirements – item-level serialisation, application of safety features and upload of the serial data to the SMVS (Swiss National Verification System) via the EU-Hub - will become mandatory in Switzerland. This follows the adoption on 26 September 2023 by both chambers of the Swiss Federal Parliament of the proposal "Master plan for the digital transformation of the healthcare system. Use of legal standards and existing data" which, among other things, instructs the Federal Council (i.e. Swiss government) to declare the application and verification of the safety features and devices as mandatory in the "Ordinance on Individual Identification Marks and Safety Devices on the Packaging of Medicinal Products for Human Use". 

As Switzerland is neither part of the EU nor the EEA, Directive 2011/62/EU (the EU-FMD) does not apply to Switzerland, and while Switzerland follows some EU regulations under bilateral agreements or mutual recognition agreements (MRA), the FMD, published as commission regulations, is not directly applicable to Switzerland. However, the legal foundation for alignment with the EU-FMD and integration with the EMVO/NMVO organisations and processes was established based on the MEDICRIME Convention and incorporated in an (almost) fully compatible and compliant manner in the Swiss Therapeutic Products Act (“Heilmittelgesetz”). It is also important to note that Liechtenstein, which is a EEA member, is subject to the EU-FMD, though under the principle of parallel marketability, Liechtenstein’s EU-FMD compliance is only mandatory for products imported under the EEA-Agreement (for example the import of Austrian packs from Austria) while compliance is optional for products supplied to Liechtenstein under the terms of the Customs Union CH-LI, i.e. supply of CH packs from Swiss Wholesalers which is the vast majority of Liechtenstein’s medicines supply. 

In general terms, the climate in Switzerland is well aligned with the objectives and principles of the EU-FMD:

• The Swiss pharma industry is hugely export-focused, and Swiss MAH that are exporting medicines are also set up to apply the Safety Features;
• SwissMedic, the Swiss NCA, is supportive of this practice and voluntary application of safety features on Swiss Market Packs is common practice;
• Scanning in pharmacies/hospitals is not yet common but getting increasingly established and given the number of medicines imported from the EU on a patient-needs basis, the ability to confirm the legitimacy of these packs by scanning them against the EU-wide database is seen as a positive feature.

It is against this background that industry stakeholders in Switzerland and Liechtenstein did set up two NMVOs and established one supranational NMVS that is fully compliant with and fully integrated with EMVO and the European Hub in 2019. This will continue to form the basis for the Q3 2025 timeline.

What is particularly interesting about the developments in Switzerland, however, is the legal basis which is different to the EU, and which allows the use of the serialised data for wider purposes. This has indeed been a key feature of the developments in the Swiss parliament where the move towards mandating the use of the system has been debated in the context of the digitalisation of the Swiss healthcare system. The discussion included the use of the data in the NMVS for monitoring medicines supply in the pandemic use case or more generally for monitoring medicines shortages, which is also an acute problem in Switzerland. While this is a hotly discussed proposition in the EU context and the current state of the legislation is seen by many to prevent the use of the EMVS data for such a purpose, the different legal but fully compatible technical set-up in Switzerland will make this a development to watch, with repercussions way beyond the Swiss market.

Excellis Europe are urging pharma to review their current European compliance against the upcoming changes sooner rather than later. Understanding these regulations will be key to continued supply within these markets. Email getsecured@excellishealth.eu to be added to our mailing list and receive regulatory updates.

Christoph Krähenbühl is widely recognised as a thought leader and technical expert in Supply Chain, Product Security, Coding, Serialization and Master Data in life-sciences/pharmaceuticals. He has been working at both the strategic and practical implementation level since the challenges of product security and coding were first recognised in the pharmaceutical industry. As Senior Director at Excellis Europe, Christoph provides specialist technical expertise (SME) in brand protection, product security, pack coding, serialisation and master data to a wider range of clients; these include pharma manufacturers from all sectors of the industry, other stakeholders in the healthcare supply chain, technology providers and supply chain customers in other industries who face similar challenges.

Excellis Health Solutions, part of NNIT Group, is a global consultancy specialising in pharmaceutical supply chain serialisation and traceability. Working with businesses across the world, from virtual start-ups through to the biggest pharma brands on the market, Excellis delivers solutions that drive value at every stage of the supply chain, helping manufacturers to prepare for new legislation in all markets.