Upcoming EU and US serialisation: fresh challenges lie ahead

Upcoming EU and US serialisation: fresh challenges lie ahead

Although it was touch and go as the deadline neared, the EU FMD system went live on deadline on 9th February this year. A very significant milestone for the EMVO and NMVOs, whom without doubt deserve commendation for this momentous development in securing the legal supply chain from falsified medicine. Yet the state of readiness for the various parties varies:

– For many manufacturers, there remains plenty of work needed to finalise their EU serialisation capabilities including final packing line implementations, getting CMO implementations over the line and establishing their L4 enterprise systems and other business processes.

– Wholesalers are in a similar position to manufacturers, finalising their systems and business processes.

– The pharmacy end of the supply chain seems to be much more variable depending on which country you are in, with many reporting that they are not yet ready. For example, in the UK, several well-known UK high street chemist chains were reported to be only partially ready one month in.

The initial go-live of the system has revealed many issues which the supply chain need to work through in the coming months. The EMVO has admitted that they were surprised by the number of alerts generated. In such an interconnected system there are many sources for those alerts, the vast majority of them unlikely to be anything to do with real falsified medicines. To this end, many country regulators have issued notices explaining that whilst the initial issues are resolved, companies should work towards full compliance, and provided interim guidance on how to respond to alerts. People I talk to agree that this situation is unlikely to resolve itself for the first 12 months.

As the EU FMD serialisation landscape continues to unfold, there seem to be several crucial areas for development:

– Alerts need to be centrally managed and automatically filtered through the likes of the EMVS. Larger MAHs are still seeing many hundreds of alerts per day and the whole supply chain is not yet up and running. At the recent GS1 Global Conference, the EMVO announced that they will be releasing functionality to help with alerts management in the Sept-Nov timeline.

– As the alerts situation settles, we can expect to see a flushing out of issues in master data and errors in the coding of product that is already in the market. I suspect we will need guidance on how to deal with some of these issues that do not require product recall.

– Access to an accurate and easily useable MAH designated supply chain partner list will be key for the effective and efficient implementation of the inbound authentication responsibilities of wholesalers.

– Wholesaler and, to a lesser extent, Manufacturer decommissioning for customers still has a way to go. Article 23 legislation adoption in Member States appears to be ongoing, as do other similar use-cases.

Lastly, aggregation remains a hot topic within EU FMD and something that needs to be resolved within the 2020 timeframe. Although not currently a legislative requirement, aggregation is allowed in the legislation and has benefit in specific scenarios. The Commission’s technical recommendations are out on this, but this is only a holding position, with the EMVO announcing that they will be formally working on this at the beginning of 2020.

Across the pond, the US continues to move forward with the phased rollout of the DSCSA regulation. Yet, as the old adage goes, if nobody is keeping score then it isn’t a game. In the US, the reality is that, at present, packs are being serialised by manufacturers, but very little downstream scanning of the serialisation is going on, so the true value and success of serialisation remains unknown.

The US focus is shifting for 2019, with the next big milestone being enabling wholesalers to perform saleable returns verifications, which for many will mean the need to connect to one of the new Verification Router Services. The implications of using VRS services are interesting:

– The model effectively negates the necessity for aggregation in the short term

– The model allows product to circulate in the downstream supply chain without the need for track and trace style serialisation scanning and communication between supply chain partners

– Those connecting to a VRS must have an L4 system running that can respond to VRS requests

– Supply chain actors need to contract with and connect to one of the many VRSs

– Processes need to be established to manage exceptions

Given the compliance deadline of November this year and the fact that the VRS vendors are only just starting to go live now, it’s going to be challenging to be ready in time.

The implementation of industry serialisation on this scale both within the EU and USA remains unprecedented and as such, each new phase of regulatory roll-out presents its own challenges. It should be acknowledged that in both cases huge steps have been made towards securing the pharmaceutical supply chain against the dangers of falsified medicines, however the journey is far from over and there remains much work to be done.

If you require help, advice or assistance with your company serialisation strategy, please get in touch. If you would simply like to request a copy of any of our serialisation booklets, please don’t hesitate to contact me at Stephen.McIndoe@be4ward.com

Be4ward provides specialist consulting services to the pharmaceutical and other highly regulated industries. We deliver value to our clients through a combination of deep subject matter expertise and excellent consulting skills. Whilst we have a thorough understanding of the supply base in our areas of focus, we pride ourselves on providing entirely independent advice to our clients.

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