The EU FMD deadline of Feb 9, 2019 is approaching fast, with only a year of implementation time left. While big pharma has largely implemented serialization, medium and small manufacturers, as well as CMOs and virtual pharmas, are lagging in beginning their implementation. Knowledgeable integration help is in short supply, as is associated hardware. The newly signed serialization regulation for Russia’s pharmaceutical market adds to the workload in EMEA.
Servicepoint is known as a leading serialization automation supplier in the Nordic. Tell us a little more about your experience with the pharmaceutical industry?
Servicepoint is one of the few companies with the skills and resources to integrate serialization to an existing production line, thus retrofit. We are a proven Finnish automation integrator with 30 years of experience in the pharmaceutical industry and have honed our skills by implementing thousands of automation projects with a variety of requirements.
Servicepoint has done more than a dozen serialization integration projects ranging geographically from France to Russia. Our experience with Systech’s UniSeries serialization solutions platform gives us the flexibility and confidence to help any European manufacturer serialize, and meet the February 2019 deadline.
With special skills in robotics including collaborative robots, Servicepoint can implement serialization and packaging automation for various production capacity needs.
When do companies in this region need to connect to the European hub for compliance reporting?
Compliance reporting through the EU Hub is required as of February 9, 2019, but companies must sign-up with a certified on-boarding partner (OBP) well before that. EMVO has recently stated that one should consider the end of June as the absolute deadline to start onboarding. It takes a lot of effort to get ready to define and integrate the necessary data with the EU Hub. This data integration is just as important as serialization, and with our partnership with Systech we can help on both counts.
Once the regulation is in place, what will happen if companies can’t serialize product?
The FMD and Delegated Regulation requires all non-exempt prescription drugs entering the EU supply chain on or after February 9, 2019 to be serialized and the associated data uploaded to the EU Hub. Companies that cannot properly meet those requirements will be forced to cease selling those drugs within the EU on that date until they can meet them. Drugs entering the supply chain without package-level serialization and/or without data loaded into the EU Hub after that date will be treated as illegitimate and will not be dispensed to patients.
What challenges specific to CMOs are you seeing? And, what are the biggest challenges that pharma companies are facing in Europe today?
We have been in discussion with a lot of small and medium-sized pharmaceutical manufacturers. Many of them are very slow in the assessment and project planning. There is often a need to rearrange production so that serialized products are concentrated to a few production lines, and non-serialized to others. One must note, however, that the division to serialize or not-serialize products varies from country to country, from market to market, and is subject to change.
Especially if there is already a parallel production upgrade project, the capacity of the company to run demanding projects may be lacking. Needs and vendor assessment, URS preparation and RFQ process all take time. They need to book the integrators to visit their production sites to have an in-depth assessment of their production lines. As the skilled project personnel of many integrators is already very much booked to implementation projects, even arranging the visits may take time.
Implementing serialization is relatively easy if one has ample room and financial resources to build a new end for a production or packaging line, but many production sites are not so spacious. Often it isn’t financially feasible to replace all the old equipment, either.
Thus, discussion about retrofit serialization installations. Machinery manufacturers are happy to sell new machinery. Installing new machinery to replace existing ones is also quite a straightforward project, given enough room. At an old manufacturing site, most or all the space is already booked by the existing production and packaging equipment. There may be little room for any new machinery. This is a case for retrofit engineering, i.e., installing as little new equipment as possible, and more automation engineering skills are required. An experienced automation integrator, such as Servicepoint, can help the pharmaceutical manufacturer through this project, by pointing out the possibilities and providing the design and implementation skills needed.
Another group of customers are early adopters who have found out that the originally cheap serialization solution they selected has been inadequate to their growing needs, for example, to accommodate new regulations. This adds stress to purchasing, as they would like to limit the cost of changing equipment and software while still keeping within the timeframe.
Summed up, there are a lot of manufacturers still sending for quotations or assessing the ones they have got — even as there is only a year to go.
How will the partnership between Servicepoint and Systech help customers achieve EU FMD compliance?
Servicepoint is a leading serialization automation supplier in the Nordic countries and it operates in all of Europe and Russia. The roots of its automation expertise go back 30 years. Based in Finland, the company specializes in industrial automation projects, maintenance, and robotic applications. Servicepoint has automated hundreds of production lines for different fields of industry, including pharmaceutical and medical device manufacturers.
Systech is a global leader in serialization and track and trace software. Both are requirements for the upcoming regulation. Systech’s experience of over 30+ years in packaging and serialization software and our production line experience provides a combined 60+ years of experience. This gives our joint customers great project confidence in implementing a solution that allows you to be compliant for the regulation now and as new regulations take effect.
The power and flexibility of Systech’s UniSeries and UniTrace solutions combined with Servicepoint’s project experience and expertise in deploying serialization give customers the industry’s best solution rooted in best practices.