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From Italy Bollino to EU Falsified Medicines Directive
10
min watch
In this video, Digital Supply Chain Track and Trace experts from IndX discuss the mandatory transition from the Bollino system to the European Union’s Falsified Medicines Directive EU FMD, which Italian pharmaceutical companies are required to comply with by 2025.
The transition includes requirements related to product serialization and digital tracking, updating IT systems and sharing data with the European Union’s centralized hub. Starting the compliance journey early is important, as the process can take months or years depending on company size, data complexity and supply chain networks.
IndX supports organizations throughout this process. For Government and Industry Regulations, IndX provides consulting, digital solutions and implementation services that cover manufacturing operations and supply chain compliance.
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.
Hi everyone. My name is Ankit Singla. I am responsible as the Global Delivery Lead for our Track & Trace practice at IndX. Very nice to meet you.
And I'm Uwe Rauschenberg. I am a Track & Trace enthusiast at IndX, 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.
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.
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.
Then we must talk about exchanging that information with the European Union database hub, the centralized European Union central database system, which is responsible for exchanging this information with all the national systems.
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.
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. This process can easily take one year to get everything changed, depending on the size of the company.
When we talk about GS1 standards, we are talking about the information in this 2D bar code with the product identifier. Instead of the authorization number issued by AIFA, we are now talking about the Global Trade Identification Number (GTIN), created using GS1 global standards by the manufacturer themselves.
Manufacturers can also create the unique identification serial number themselves, with a randomization factor of 1 by 10,000, without depending on authorities to provide the numbers.
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. 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.
When we transition from Bollino to the EU FMD 2D barcode in a smart way, we are enabling manufacturers to use a global approach. The introduction of global standards in product serialization and labeling enables additional advantages, such as the e-leaflet, allowing more information to be accessed by consumers or medical practitioners and reducing the need for paper-based leaflets.
The EU FMD regulation drives a comprehensive approach across the supply chain, enabling more reliable event tracking. It also introduces a point-to-dispense model, with mandatory verification when the product is given to the 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.
If you have more questions, just talk to us. IndX is ready to help you.
Ankit, thank you very much. Yes, it was a pleasure talking to you. Thank you.
