Medicine manufacturers have been working hard with serialisation vendors to comply with requirements under the Falsified Medicines Directive (FMD) of 2011 which specifies safety features for packaging used on medicines. To be compliant individual medicine packs (the lowest saleable unit) must carry a unique identifier (UI) or serial number displayed as human readable text and embedded within a machine readable 2D matrix. The product must also contain anti-tamper evidence. This process alone has proven to be more complex and more expensive for brand owners than had ever been expected.
The European Federation of Pharmaceutical Industries 7 Associations (EFPIA) report that the research based multi-national medicine manufacturers seem to be the most prepared. However, several industry publications are reporting that some small and medium sized producers and CMOs/CPOs may miss the deadline for serialisation regulation.
Beyond the UIs and the tamper-evident seals there is a massive IT infrastructure organised by the European Medicines Verification Organisation (EMVO). The EMVO receives verified product UI data and distributes the data to the relevant market National Verification Organisation (NVO). At the end of the supply chain a medicine scanned at a pharmacy, for example, will be verified against the data held at the NVO before being released to the patient.
For this process to work seamlessly the Marketing Authority Holder (MAH) needs to become and Onboarded Partner (OBP) with the EMVO. In March of this year the EMVO reported that only ¼ of the 2000 pharmaceutical companies had become OBPs and confirmed that the progress was far behind schedule.
The Pharmaceutical Technology Europe publication were also reporting, as late as this summer, that ‘organisations responsible for running the project at national level may not have the IT infrastructure in place’. The EMVO is ready and has been receiving serialised data from many MAHs and distributing the data to the NVOs ready to receive it such as Germany. However, there is doubt about the readiness of many of the 28-member states to provide the necessary infrastructure and process by the 9th February 2019 deadline.
Most pharmaceutical manufacturers have spent considerable managerial and administrative time as well as financial resources to ensure the physical packaging complies to regulation. Several have on-boarded with the EMVO whilst other are still battling through that process. For those that have ticked both boxes there is still no guarantee the NVOs will be ready to complete the verification process for every European market they serve.
Of course, the above will become irrelevant if your chosen pharmacy doesn’t have the means to scan the 2D code of your prescription medicine; or they don’t have a robust broadband connectivity to verify the code with the NVO!
1. European Commission, Delegated Regulation Laying Down Rules for the Safety Features Appearing on the Packaging of Medicinal Products for Human Use, Delegated Regulation 2016/161 (Brussels, February 2016).
2. J. Verhaeghe, “Where Will FMD Lead Us?’” Presentation at Adents Serialization Innovation Summit (Paris, April 2018).
3. EMVO, “Announcement—500 participation agreements signed,” Press Release, 12 Mar. 2018.
4. EMVO, “Announcement—One Additional Country Connected to EU Hub,”’ Press Release, 26 Apr. 2018.