Brian Daleiden and Caitlin Czulada, VP of Industry Marketing, TraceLink and Manager, Technical Services, TraceLink06.06.17
The EU Falsified Medicines Directive (FMD) goes into effect in February 2019, incorporating a variety of initiatives aimed at protecting both patient safety and product integrity as medicines move through the pharmaceutical supply chain.
While at first glance, the EU FMD may look relatively straightforward, especially when compared to other global track and trace regulations, in reality the EU directive is much more diverse than it appears. Implementing solutions to serialize products, manage product serialization and master data, and connect to the EU Hub to share and manage information across the product lifecycle requires more preparation than some manufacturers may be expecting.
This article provides an overview of the EU FMD and shares key serialization considerations for pharmaceutical companies that produce and distribute medicines for the European markets through the knowledge TraceLink and its customers have gained from early pilot programs.
The EU FMD
The EU FMD introduces tough new rules to improve the protection of public health, bringing a new pan-European approach to ensure the safety of medicines. Essentially, the goal is to create a European Medicines Verification System with point-of-dispense verification for most prescription medicines and selected high-risk over-the-counter (OTC) products. This will be achieved through unique identity encoding and the application of serialization onto every packaging unit.
The EU FMD covers three regulatory areas:
Serialization requires the sharing of high-level information between a complex web of stakeholders in the supply chain. Manufacturers that supply products to the EU will be required to exchange information with their supply network and report data about a product’s serialization identity to the national repositories through the EU Hub.
Processes may vary slightly, but in the first instance the manufacturer or marketing authorization holder (MAH) will be responsible for packaging and serializing the drug product. Their process may involve working with internal sites, with CMOs, or in conjunction with third party logistics (3PL) distribution sites.
The MAH will then be required to submit product master data, and packaging data including serialization information to the EU Hub. This requires establishing an account with the European Medicines Verification Organization (EMVO) through their on-boarding process and determining how the resultant On-Boarding Partner (OBP) will connect to and communicate information to the Hub.
Parallel importers/distributors (PI) must also submit similar data into the EU Hub for the medicines they repackage or relabel. Think of the Hub as a ‘router’ that takes information about a product and passes it to the national systems serving the market(s) where that product is targeted for distribution.
Pharmacies are then able to perform verification enquiries against the national system in their country.
EU serialization, verification and compliance
The EU FMD requires four key data elements to be encoded and submitted to the EU Hub. The first is the manufacturer product code. There is no single form of product code used across Europe. Depending on the country that a particular product is being targeted in, this product code may be a global trade item number (GTIN), a national trade item number (NTIN) or a unique national market code. Multi-market packs may require more than one product code to be configured.
A serial number must be added that adheres to a 1:10,000 randomization methodology. Finally, the expiration data and batch number also need to be applied. Other additional data elements may include a national healthcare reimbursement number (NHRN), which can enable products to be distributed across multiple countries. All information must be provided in both human readable form and encoded in a 2D data matrix code.
Reporting requirements
The MAH/PI must generate and manage many details about products that are being prepared for sale. The data, which may span across multiple transactions being reported to the EU Hub, includes information such as the product master data reporting requirements. This includes the product code, product strength, pack type and pack size. It also includes information about the markets and member states that a product will be distributed into, as well details of the MAH and the wholesalers authorized to store and distribute the product on behalf of the MAH.
Serialized product pack data, which includes the unique product identification information about every individual sales pack needs to be reported, as well as notifications of any batch recalls. Should product master data be modified, or the status of a product pack be changed, this information needs to be updated in the EU Hub.
The frequency of data transactions will vary. For some types of information, such as the product master data, this may need to be submitted initially and only updated if the information changes. For other information, such as the product pack serialization data, companies will have to determine how often and with what granularity this is communicated, batch-by-batch, shipment-by-shipment, or other.
Finally, any serialization information or related product data, which is produced or modified by CMOs or 3PLs, is the responsibility of the MAH to capture and report to the EU Hub.
Other regulatory requirements and considerations
There are several product coding schemes in existence and depending where a product is targeted, MAHs may have to apply different product codes and submit these to the EU Hub as part of the product master data. Depending on the country, the serialization and compliance system may need to manage a variety of different complex coding schemes. In particular, the GTIN-14, GS1 NTIN and the Pharmacy Product Number (PPN).
Further challenges include the issues related to multi-market packs that may be distributed into multiple countries. While the regulations do not allow packaging to have more than one 2D data matrix code, there is an ability to add additional product codes into the barcode following specific encoding rules.
Manufacturers must keep records of every operation they perform using a unique pack identifier and unique product identifier. There is a requirement for records of both of these activities to be kept for one year past the expiration date or five years after the pack has been supplied into the supply chain.
Finally, there are also grandfathering and catch-up provisions. Products that are packaged and released for sale before February 2019 may be distributed and sold until the expiration date. Records of products, which are serialized and released into the market prior to February 2019, should be kept to enable submission to the EU Hub when the deadline occurs, thus enabling the Hub to have a correct record of all serialized packs which have been put into the supply chain.
EU FMD preparation readiness
Early EU FMD pilots have uncovered the potential implementation issues in achieving compliance, providing valuable considerations for manufacturers. If you are a manufacturer or MAH that needs to comply with the EU FMD regulations, consider the following:
An effective implementation roadmap should ideally follow these steps:
Serialization impacts many different groups within the pharmaceutical supply chain and it’s not as simple as just applying a 2D matrix code to a bottle. Manufacturers will need to coordinate with many different teams, internally and externally.
Preparing early and creating a plan for serialization will be fundamental in avoiding delays. The legal deadline to connect to the EU Hub is February 9, 2019. There is however, a practical business need to test connections several months beforehand.
Selecting a serialization solution
The EU market is the largest regional market for medicines in the world. The complex set of compliance requirements will impact not only a pharmaceutical organization but the entire supply chain network. It is vital to choose a serialization solution that can deliver network connectivity, scalability and compliance capabilities that ensure supply.
The ability to connect to a track-and-trace network for the pharmaceutical supply chain via a single connection has the potential to significantly speed-up and simplify the ability to serialize, report and manage products for compliance. Equally, being able to take advantage of already established connections to the EU Hub, as well as gain access to an existing EMVO account, could significantly shorten compliance timelines.
It is also fundamental to look for a serialization data exchange solution that is scalable and can handle the billions of serialization numbers generated. When preparing for serialization, flexible solutions will be key—the regulatory landscape is likely to evolve for years to come and a forward-thinking approach that considers future markets and requirements can ensure compliance now and for the long-term.
Final thought
Compliance with the EU FMD is a challenging process for any manufacturer. Establishing plans now, and considering the impact serialization will have on each stakeholder in the supply chain, will be crucial in meeting the 2019 deadline. The implementation of serialization will bring together many different groups and requires careful program management. Working with a serialization partner that can offer a tried-and-tested connection to the EU Hub will help to alleviate some of the complexity of the task at hand, ensuring both a smoother transition and minimizing risks. CP
Brian Daleiden is vice president of industry Marketing at TraceLink.
Caitlin Czulada is Tracelink’s manager of technical services.
While at first glance, the EU FMD may look relatively straightforward, especially when compared to other global track and trace regulations, in reality the EU directive is much more diverse than it appears. Implementing solutions to serialize products, manage product serialization and master data, and connect to the EU Hub to share and manage information across the product lifecycle requires more preparation than some manufacturers may be expecting.
This article provides an overview of the EU FMD and shares key serialization considerations for pharmaceutical companies that produce and distribute medicines for the European markets through the knowledge TraceLink and its customers have gained from early pilot programs.
The EU FMD
The EU FMD introduces tough new rules to improve the protection of public health, bringing a new pan-European approach to ensure the safety of medicines. Essentially, the goal is to create a European Medicines Verification System with point-of-dispense verification for most prescription medicines and selected high-risk over-the-counter (OTC) products. This will be achieved through unique identity encoding and the application of serialization onto every packaging unit.
The EU FMD covers three regulatory areas:
- Serialization. Applying a unique identity at the secondary sales pack level;
- Compliance reporting. Preparing and reporting master data, serialization data and status information to the European Hub; and
- Verification. Implementing point-of-dispense verification that also includes risk-based verification for other members of the supply chain.
Serialization requires the sharing of high-level information between a complex web of stakeholders in the supply chain. Manufacturers that supply products to the EU will be required to exchange information with their supply network and report data about a product’s serialization identity to the national repositories through the EU Hub.
Processes may vary slightly, but in the first instance the manufacturer or marketing authorization holder (MAH) will be responsible for packaging and serializing the drug product. Their process may involve working with internal sites, with CMOs, or in conjunction with third party logistics (3PL) distribution sites.
The MAH will then be required to submit product master data, and packaging data including serialization information to the EU Hub. This requires establishing an account with the European Medicines Verification Organization (EMVO) through their on-boarding process and determining how the resultant On-Boarding Partner (OBP) will connect to and communicate information to the Hub.
Parallel importers/distributors (PI) must also submit similar data into the EU Hub for the medicines they repackage or relabel. Think of the Hub as a ‘router’ that takes information about a product and passes it to the national systems serving the market(s) where that product is targeted for distribution.
Pharmacies are then able to perform verification enquiries against the national system in their country.
EU serialization, verification and compliance
The EU FMD requires four key data elements to be encoded and submitted to the EU Hub. The first is the manufacturer product code. There is no single form of product code used across Europe. Depending on the country that a particular product is being targeted in, this product code may be a global trade item number (GTIN), a national trade item number (NTIN) or a unique national market code. Multi-market packs may require more than one product code to be configured.
A serial number must be added that adheres to a 1:10,000 randomization methodology. Finally, the expiration data and batch number also need to be applied. Other additional data elements may include a national healthcare reimbursement number (NHRN), which can enable products to be distributed across multiple countries. All information must be provided in both human readable form and encoded in a 2D data matrix code.
Reporting requirements
The MAH/PI must generate and manage many details about products that are being prepared for sale. The data, which may span across multiple transactions being reported to the EU Hub, includes information such as the product master data reporting requirements. This includes the product code, product strength, pack type and pack size. It also includes information about the markets and member states that a product will be distributed into, as well details of the MAH and the wholesalers authorized to store and distribute the product on behalf of the MAH.
Serialized product pack data, which includes the unique product identification information about every individual sales pack needs to be reported, as well as notifications of any batch recalls. Should product master data be modified, or the status of a product pack be changed, this information needs to be updated in the EU Hub.
The frequency of data transactions will vary. For some types of information, such as the product master data, this may need to be submitted initially and only updated if the information changes. For other information, such as the product pack serialization data, companies will have to determine how often and with what granularity this is communicated, batch-by-batch, shipment-by-shipment, or other.
Finally, any serialization information or related product data, which is produced or modified by CMOs or 3PLs, is the responsibility of the MAH to capture and report to the EU Hub.
Other regulatory requirements and considerations
There are several product coding schemes in existence and depending where a product is targeted, MAHs may have to apply different product codes and submit these to the EU Hub as part of the product master data. Depending on the country, the serialization and compliance system may need to manage a variety of different complex coding schemes. In particular, the GTIN-14, GS1 NTIN and the Pharmacy Product Number (PPN).
Further challenges include the issues related to multi-market packs that may be distributed into multiple countries. While the regulations do not allow packaging to have more than one 2D data matrix code, there is an ability to add additional product codes into the barcode following specific encoding rules.
Manufacturers must keep records of every operation they perform using a unique pack identifier and unique product identifier. There is a requirement for records of both of these activities to be kept for one year past the expiration date or five years after the pack has been supplied into the supply chain.
Finally, there are also grandfathering and catch-up provisions. Products that are packaged and released for sale before February 2019 may be distributed and sold until the expiration date. Records of products, which are serialized and released into the market prior to February 2019, should be kept to enable submission to the EU Hub when the deadline occurs, thus enabling the Hub to have a correct record of all serialized packs which have been put into the supply chain.
EU FMD preparation readiness
Early EU FMD pilots have uncovered the potential implementation issues in achieving compliance, providing valuable considerations for manufacturers. If you are a manufacturer or MAH that needs to comply with the EU FMD regulations, consider the following:
- Consideration 1: Understand program and business requirements to determine a plan for serialization. Determine the current scope of your products and how they are impacted by the regulations. In addition, gain an understanding of how products are packaged, i.e. is this done in-house or outsourced? Will your products be aggregated or not aggregated? What will be the trigger for sending data to the EU Hub—will it be shipment or product release? Taking a complete look at internal business processes will provide a picture of what needs to be accomplished.
- Consideration 2: Understand the requirements and differences market-by-market. Once the full scope of products and business processes are understood, think about your requirements in different market regions and how these will be met. If you may be selling pharmaceutical product into different markets in the future, determine how this will be accounted for.
- Consideration 3: Understand best practices and lessons learned for serialization. If you’ve implemented serialization strategies for markets with existing legislation such as Turkey and China, consider incorporating best practices from those programs. If you do not have any prior experience, speak with other manufacturers, vendors and solution providers that can provide valuable guidance on best practices. One lesson applies universally to all markets—start earlier than you think you need to, this will ensure enough time for any unforeseen challenges that may arise.
- Consideration 4: Understand the questions to ask partners to determine serialization readiness. Serialization will require the exchange of information with multiple partners, including regulatory authorities, contract manufacturers, contract packagers and third party logistics providers (3PLs). Once you understand your own business requirements, communicate these clearly to all of your trade partners. In turn, ask your partners about their previous serialization experience, existing lines for serialization or plans for line upgrades, and their capabilities for data exchange.
An effective implementation roadmap should ideally follow these steps:
- Select an enterprise software solution. This is the solution that will enable manufacturers to provide information to the EU Hub.
- Map out CMO/CPO/3PL partners and evaluate their integration plans. Companies need to ensure that their partners’ plans fit within their timelines.
- Determine your serialization and aggregation plans with line systems. What will this mean in terms of adaptations to lines and requirements for new equipment?
- Define inventory management with serialization. Serialized products will add a new level of complexity to warehouse management that will need to be managed.
- Accommodate all country requirements and compliance.
- Test end-to-end data flows with trade partners. This will involve all partners, the EU Hub, national systems and even pharmacies at the point of dispense.
- Plan production runs with required lead times.
Serialization impacts many different groups within the pharmaceutical supply chain and it’s not as simple as just applying a 2D matrix code to a bottle. Manufacturers will need to coordinate with many different teams, internally and externally.
Preparing early and creating a plan for serialization will be fundamental in avoiding delays. The legal deadline to connect to the EU Hub is February 9, 2019. There is however, a practical business need to test connections several months beforehand.
Selecting a serialization solution
The EU market is the largest regional market for medicines in the world. The complex set of compliance requirements will impact not only a pharmaceutical organization but the entire supply chain network. It is vital to choose a serialization solution that can deliver network connectivity, scalability and compliance capabilities that ensure supply.
The ability to connect to a track-and-trace network for the pharmaceutical supply chain via a single connection has the potential to significantly speed-up and simplify the ability to serialize, report and manage products for compliance. Equally, being able to take advantage of already established connections to the EU Hub, as well as gain access to an existing EMVO account, could significantly shorten compliance timelines.
It is also fundamental to look for a serialization data exchange solution that is scalable and can handle the billions of serialization numbers generated. When preparing for serialization, flexible solutions will be key—the regulatory landscape is likely to evolve for years to come and a forward-thinking approach that considers future markets and requirements can ensure compliance now and for the long-term.
Final thought
Compliance with the EU FMD is a challenging process for any manufacturer. Establishing plans now, and considering the impact serialization will have on each stakeholder in the supply chain, will be crucial in meeting the 2019 deadline. The implementation of serialization will bring together many different groups and requires careful program management. Working with a serialization partner that can offer a tried-and-tested connection to the EU Hub will help to alleviate some of the complexity of the task at hand, ensuring both a smoother transition and minimizing risks. CP
Brian Daleiden is vice president of industry Marketing at TraceLink.
Caitlin Czulada is Tracelink’s manager of technical services.