Falsified medicines represent a major public health threat, appearing in the market as legitimate products that can reach patients across the EU and around the world. In response to an increased risk of counterfeiting, in 2013 the EU Commission enacted Directive 2011/62/EU – also referred to as the EU Falsified Medicines Directive (FMD). This legislation introduces track and trace regulations that enable harmonised, European-wide measures to rigorously control the safety and supply of medicines for human use.
The FMD requires that all unit-of-sale packs of prescription medicines must carry a “safety feature” comprising a Data Matrix code and human readable data, and must be tamper-evident. The code must contain a minimum of four pieces of information: batch number, expiry date, global trade item number (GTIN) and a randomized serial number. Some countries require a fifth data string for national use. The data must also be printed in human readable form, ideally adjacent to the code. Manufacturers (and licensed parallel traders) will code their products and report data to a central EU Hub run by the European Medicines Verification Organisation (EMVO). This will push data down to appropriate national data repositories run by corresponding National Medicines Verification Organisations (NMVOs). Pharmacists (or other authorized persons) will scan the codes during the dispensing process and these codes will be checked against the local databases.
The date chosen for the FMD legislation to come in force was 9 February 2019. Being a CDMO Siegfried was impacted by this legislation, more specifically its three sites: Hameln, Irvine and Malta. For Siegfried Malta the journey started back in 2016, when the initial meetings to assess the requirements and to select the supplier of the system to be used, were set. Uhlmann GmbH was the company selected to supply the necessary Level 1–5 equipment. Several meetings were held in order to assess the upgrades and the new equipment required for compliance with the FMD legislation.
Within the past two years, a substantial amount of work was undertaken in preparation for implementation of the project. Surveys were sent to clients with the purpose of passing information on Siegfried’s strategy for implementation and also to collect data required for the project. Regular teleconferences were held for information exchange between both parties.
The FMD directive requires products to have a tamper evident feature, and due to space limitations the choice for both packaging lines in Malta was to use hot-melt technology. This meant that all the designs and artworks of all folding boxes, even those used for markets not impacted by serialisation had to change. A new design of folding box was created and templates were sent to clients in order to implement the new artwork.
In April 2018, the packaging lines were upgraded with hot-melt functionality, whilst line and site servers were installed. Following validation, the first batches with folding boxes containing a tamper evident feature and with variable data printing controlled by the line server operating in local mode were packed. This was a big milestone for the Siegfried Malta site.
We then moved on to the next phase: the on-boarding for serial number exchange between Siegfried Malta and its respective clients. The work involved at this stage was substantial and following several end-to-end tests and simulation runs we were finally ready to go live.
On 14 January 2019, the first commercial serialised batch was packed. This milestone was achieved through the collaboration and hard work of various entities within Siegfried Malta (Production, IT, Supply Chain and Quality), Siegfried Zofingen (Business Development, Customer Services and IT) and the Global Project manager in Irvine.
The journey of Siegfried Malta with respect to serialisation is definitely not over. Notwithstanding the successful implementation registered so far, the process is dynamic, and new challenges thus await. We strongly believe that investing yet more energy into this project will ensure it continues to be a successful one.