From Italy Bollino to EU Falsified Medicines Directive

In this video, our Digital Supply Chain (Track & Trace) experts from Engineering Industries eXcellence discuss the mandatory transition from the Bollino system to the European Union's Falsified Medicines Directive, or EU FMD, with which Italian pharmaceutical companies will have to comply by 2025. The transition involves a number of different requirements for product serialization and digital tracking, updating IT systems and sharing data with the European Union's centralized hub. Starting the compliance journey early is critical, as the process can take months or even years, depending on the size of the company, the complexity of the data and the supply chain networks involved. Engineering Industries eXcellence is here to guide you through the process. When it comes to Government & Industry Regulations, Engineering Industries eXcellence can provide expert consulting, holistic digital solutions and implementation services covering manufacturing operations and supply chain compliance.

Interested in speaking to one of our experts? Contact us at info@indx.com.

Full Video Transcript

Hello everyone and thank you very much for attending. In the next 10 minutes, we would like to talk to you about the Italian Bollino system, and to present a smart way to transition from Bollino to the European Union's Falsified Medicines Directive (EU FMD) by 2025. Let's start with a quick introduction. Hi everyone. My name is Ankit Singla. I am responsible as the Global Delivery Lead for our Track &Trace practice at Engineering Industries eXcellence. Very nice to meet you. And I'm Uwe Rauschenberg. I am a Track & Trace enthusiast at Engineering Industries eXcellence, responsible for our business in Europe and the Middle East. Very happy to talk to you.

Now, perhaps the first explanation about what is Bollino and what is the European Union's Falsified Medicines Directive. Ankit, can you describe Bollino in two or three sentences? Yes, Bollino is a two-layer adhesive label which appears on the packaging of medications. The Bollino barcodes are managed by the Italian medical agencies, specifically the Italian Medicines Agency (AIFA) using the National Health Information System (NSIS). The European Union Falsified Medicines Directive, on the other hand, was put in place starting in February 2019 to fight counterfeit and control medical product distribution in the European Union.

Bollino is a 1D barcode and adhesive label with a tamper-evident device on top of a pharmaceutical package. The European Union Falsified Medicines Directive will require a 2D data matrix code and unique identifier. Having and knowing that the EU FMD gives the chance of verification at the end, at the point of dispense - this is the main functionality. The Bollino is carrying a lot of data along the lifetime of the Bollino product. So, while it looks at the first line that we have an advantage between Bollino and EU FMD, Italy has to switch from A to B.

So, what does it mean for the Italian industry? What does it mean for a manufacturer? When changing from Italian Bollino to European Union Falsified Medicines Directive, there will have to be a lot of changes done. Can you name some of these important changes? So, as we mentioned, while the EU FMD was put in place from February 2019, the regulation was exempted from Italy because the Bollino system was already in place there from early 2000. This exemption was made back in February 2019 for six years. So, this means that soon the industry has to comply with the EU FMD in Italy, too. When we are talking about making a switch from Bollino to EU FMD compliance, where we are using the 2D data matrix barcode, we are first talking about making a switch that will involve the manufacturers looking at their artwork and labeling process. For their packaging lines, this will mean preparing all this information in their IT systems. And then we must talk about exchanging that information with the European Union database hub. Because when we talk about the EU FMD, we must talk about preparing all the information and then sending it to the European hub, the centralized European Union central database system, which is responsible for exchanging this information with all the national systems. So, when we talk about in Italy, we are talking about first provisioning the Bollino barcode and then having this on the Bollino label. And then we are talking about complying with the new 2D data metrics barcode, preparing that information and then sending it to the European hub.

One of the main differences is that in Italy, you will receive the unique identifier which you need to use. With the European Union Falsified Medicines Directive, you can create the unique identifier on your own. This is an advantage. But important to note is that you need to take each and every pack and have to look at the artwork there. Today we have the Bollino label on this side. Tomorrow, we will need to have the 2D data matrix code like this on the package. So, it will be quite a lengthy process to review label formats when you have a lot of products. That means starting early is definitely an advantage, as we are now approaching the end of the year 2023. This process, which usually depend on the size of the company, can easily take one year to get everything changed.

What can you say about the GS1 standards being used for the EU FMD and the advantages of having these standards? When we talk about Bollino in place in Italy, as we said, it has two layers, packing labels. And when we talk about the European Union Falsified Medicines Directive, we are talking about a more comprehensive approach for the complete European Union. This includes the information in the 2D bar code as well as the anti-tempering device. So, this is already taken into consideration with all the security measures which the Bollino barcode has established and has in place. When we talk about GS1 standards, we are talking about the information in this 2D bar code with the product identifier. We have the authorization number with nine digits, or AIC, issued by the Italian Medicines Agency in place with Bollino. Now, we are talking about the Global Trade Identification Number, or GTIN, created using GS1 global standards by the manufacturer themselves. And also, when we talk about Bollino, we are talking about the unique identification number, or UID, provisioned by the Italian government. With the EU FMD, manufacturers can create the unique identification serial number themselves too. So, the European Union provisions to have a randomized serial number which can be created on your own, with a randomization factor of 1 by 10,000. You don't need to depend on the authorities to provide you the numbers. You can create your numbers yourself.

Next, we need to adopt the GS1 standards in exchanging information. That gives us the advantage of having a clearer view of the different events which happen along the supply chain. But this is a story of its own. Today, we want just to focus on the advantages you can gain by transitioning from Bollino to the European Union Falsified Medicines Directive in a smart way. What are the possible advantages when changing from Bollino's 1D barcode to the 2D data matrix code? Let us name a few. When we transition from Bollino to the EU FMD 2D barcode in a smart way, we are enabling manufacturers to use a global approach. If they are already producing for, let's say, other markets in the European Union, the introduction of global standards in product serialization and labeling will enable them to leverage some additional advantages, like the e-leaflet. For example, when you introduce the e-leaflet using the same 2D barcode, you can enable more information to be available within that same barcode - information that can easily be viewed by the consumer or even the medical practitioners. The need for the paper-based leaflet can also be taken away. The EU FMD regulation drives a comprehensive approach. It brings in all the manufacturers and players across the supply chain, so you can track all your events in a much more reliable way. The EU FMD also has a point-to-dispense model. Here, we are talking about making sure that you push the information to the European Union hub. You have optional verification points along your supply chain, but you have a mandatory verification at the point-of-dispense, when you are giving the product to your consumer.

The journey from Italy's Bollino 1D barcode system to the European Union's Falsified Medicines Directive's 2D data matrix barcode is not just about changing codes. It is about global standards for compliance, data exchange across the supply chain and the ability to communicate with and give more information to your end consumers. You can easily implement product recalls and add additional functionality throughout your complete supply chain wherever and whenever needed. If you have more questions, just talk to us. Engineering Industries eXcellence is ready to help you. Ankit, thank you very much. Yes, it was a pleasure talking to you. Thank you.