It is the general consensus amongst close observers that the draft of the EU-Falsified Medicines Directive “Safety Features” Delegated Act (DA) posted on the 13th August 2015 on the EU Commission website is very close to the definitive version that is planned to be adopted by the end of September.
This means that by early 2019 (or possibly even late 2018), every pharma manufacturer that supplies Europe – originator, generics manufacturer, virtual pharma company, parallel traders, re-packagers or CMO – needs to have adapted their packs, implemented their tamper evidence capability, to have established their systems, processes and master data to be in full compliance with the EU-FMD, otherwise they are no longer in a position to sell their products in the European Market.
As practitioners, who have been working with pharma companies to implement these capabilities, we are fully aware of the size of the task ahead: The time for implementation is now not long at all, the challenges are many and the capacity to provide equipment and solutions for the hundreds of pharma manufacturers and the thousands of manufacturing lines producing for the European market is being booked as we speak.
The task ahead is daunting and not all details of the proposed legislation are well understood. As long-time close observers of developments in Europe, we have taken the time to look in detail at this final draft Delegated Act to pull out the key messages and actions required by pharma manufacturer to enable them to calibrate what they now need to consider.
Download the full analysis here that covers the following point:
Scope – markets: 29 markets from late 2018 or early 2019, the remaining three – Italy, Belgium and Greece – from 2024/2025.
Scope – products: All prescription only medicines supplied to the public are in scope and the first items on the OTC blacklist have also already been announced.
Unique Identifier and Data Carrier: Every manufacturer therefore now needs to establish the capability to generate, print, capture, verify and store and manage the 4- or possibly 5-element Unique Identifier carried in a 2D Data Matrix printed on each and every pack.
Pack, Artwork, Tamper-Evidence: Alongside the challenge to ensure their packs are serialisation-ready (pack substrate and finishing, artwork readiness, printing and visioning technologies) pharma manufacturers need to ensure that every pack supplied is tamper-evidenced when supplied to the European Market.
Item-level but also ‘aggregation ready’: While the European approach focuses on the pack/item-level for the major use case envisioned (point-of-dispense verification), there are a number of situations where operating at a higher level of aggregation will make a lot of sense (and has been deemed acceptable by the law-maker). It does therefore make sense that even if manufacturers limit their implementation initially to item-level, their requirements should specify the aspiration to provide at least ‘aggregation ready’ equipment.
Europe-wide ‘repositories’ infrastructure: The responsibility to upload the data to the repositories has now been clearly assigned to the Marketing Authorisation Holders supplying pharmaceutical products into the European Market. This obliges every MAH to establish a secure and capable company repository to fulfil their data reporting, data management and record-keeping obligations.
Obligations on parallel distributors/repackagers: The same obligation also explicitly applies to parallel distributors / repackagers who need to the capabilities to capture and upload the serial numbers of the original packs used in the repacking process.
Contract manufacturers: CMO may not fall under the direct data upload obligation but it is difficult to see how they would be in a position to control the supply of the appropriate information to their customers without also establishing a CMO company repository. In fact, given the typical CMO’s position of supplying multiple customers and possibly managing a complex mix of prescription and OTC products for a wide range of markets, the size of the challenge facing them may well dwarf the challenges faced by other pharma manufacturers
Cost implications: In addition to establishing (and maintaining/operating) their in-house serialisation and tamper-evidence capability at line and at corporate repository level, pharma manufacturers are required to fund the establishment and on-going operation of the Europe-wide repositories system infrastructure. The good news is that, through the various organisations representing their interests at the European level, much work has been done to establish a capable but cost-effective approach in the form of the European Stakeholder Model.
There is a big challenge ahead for all pharma manufacturers: What is required to be covered in terms of technology – at line and at the corporate level – is significant. However establishing that serialisation technology stack is only part of the work that needs to be undertaken, and against the background of tight timelines, companies setting off now on their implementation journey cannot afford to risk getting things wrong at this late stage: The budget for every EU-FMD readiness programme needs to make provision not just for the technology but for expert help and support that will more than pay for itself in the long run.