EU FMD: the countdown to 9th February 2019
For the last few years, pharmaceutical manufacturers, contract manufacturers, packers, wholesalers, in fact anyone shipping or even marketing product to Europe, have been preparing for the adoption of the Falsified Medicines Directive. The adoption deadline of 9th February 2019 looms large for businesses who are yet to prove themselves operationally ready. But there’s still time to get your business on the right side of compliance.
Item-level serialisation will improve your business
The FMD legislation calls for item-level serialisation of pharmaceutical products to ensure each item is tracked securely through the supply chain. This will help to tackle the major problem of counterfeit medications making their way onto the market, a problem that costs the pharmaceutical industry hundreds of millions of Euros every year. Item-level serialisation provides a record of provenance and secures patient welfare.
Yet there are operational benefits for pharma businesses too.
Domino has already helped a vast number of manufacturers make their production lines fully FMD compliant (see our previous blog from 2015). Early adopters have realised reductions in waste, improvements to supply chain efficiency and enhanced control of products. There’s also the potential for item-level serialisation to springboard your business into the Big Data revolution – where serial numbers give you better insight on where your products are consumed.
Of course, the main benefit is that your business remains legally compliant and able to trade in the market - avoiding regulatory fines and prohibitions on sales. Yes, the move to item-level serialisation can be a learning curve. Yes, there are challenges - such as the initial financial outlay and a temporary reduction in productivity. But in the long-term, your business can only benefit.
Yes, you need to be prepared for these challenges named above, however it’s also important to ensure that your distributors are compliant too. Our North America team have produced a blog post on the importance of distributor compliance.
How long will it take to adjust your operations?
Depending on your company’s size, the process can take six to nine months. Domino may be able to work within a smaller timeframe to get you compliant, but the time to act is now. In some cases, it has taken multiple years to gradually adjust their operations to meet the FMD deadline.
How much will FMD compliance cost?
Again, it’s hard to ascertain a specific figure. But there’s no denying that adjusting your production environment for item-level serialisation is likely to be a significant investment. The average cost per line we’ve seen is between €100K for smaller manufacturers and €250K for mid to large-sized firms. The process isn’t easy, and your overall equipment efficiency will take a knock in the short term.
What about aggregation?
Some pharmaceutical businesses have used the adoption of item-level serialisation technology to introduce aggregation on the shipper and pallet levels as default. That is certainly something to consider in an environment where increasing numbers of logistical firms are announcing that they will only accept aggregated products.
Have you considered where you would need to label on your pallet? And other requirements that are in place with the new legislation?
Are you ready? We are, and we can help.
For latecomers, options to incrementally adopt the technology and processes necessary for item-level serialisation remain available. But the time to act is now if you want to avoid regulatory fines or prohibitions on sales.
If you read one e-guide this week, make it this one. It’s short, sharp and packed with information about how to get your business compliant with the FMD regulations. Or for a free consultative health check of your production lines, book one of our serialisation experts to visit your facilities.