Serialisation has been mandatory for the pharmaceutical industry since 2019. The EU Falsification Directive is a challenge for logistics processes and compliance. This costs time and ties up staff. With Lean FMD, medAspis revolutionises FMD in terms of compliance and speed.
The Falsified Medicines Directive enables comprehensive digital monitoring of logistics processes. What digital footprints does your company leave behind? How do the authorities deal with counterfeit alerts? Find out the most important answers now and how you can protect yourself.
Simply scan 100% GxP compliant, error-free and lightning fast in one go:
» At three different locations, we move 1.2 billion pharmaceutical packages every year. Therefore, Lean FMD and its resulting efficiencies are perfect for us. The medAspis experts also accompanied us during the implementation according to GxP guidelines on every single step. They responded flexibly and competently to our wishes and implemented them together with us. The FMD solution is now perfectly integrated into our own systems.
Our conclusion: medAspis is a strong partner in every respect. «
» medAspis is responsible for the rapid recording of 2D codes in our incoming goods department. Batch control and verification are carried out in the same step, which saves time. The order data comes from Microsoft Dynamics and the data for the finished orders is saved back there. This means that everything in the system is always up to date, fully automatically. medAspis sends the serial numbers to our onboarding partner Tracekey for further processing. «
» For reasons of efficiency, we need a simple and accurate FMD process. The medAspis solution can transfer all data directly to our ERP system. We also appreciate the ability to capture data only. We scan in goods receipt and export later without having to scan again. That really makes our work easier. «
» medAspis has been working for us since the beginning of the Falsified Medicines Directive. We have always been impressed by the speed at which it works. It makes our work even faster and more precise than before. We have gradually integrated more and more functions into our IT. All important data now flows fully automatically into our SAGE system. «
Please allow up to 24 hours for your order to be processed. We will then send the newly generated Aggregation Codes as a PDF to the email address provided here.
Do you suspect counterfeiting? Our medAspis Alert Team will assist you with the process. We are also happy to assist you with unclear error messages or unfamiliar situations.
Describe the incident using the report form. If needed, you can upload up to three photos. We will contact you as soon as possible and support you with the next steps.
medAspis is committed to quality. Our customers rightly expect impeccable quality and comprehensible processes.
Our Validation Toolkit makes validation of our Lean FMD a breeze.
Simply download the first few pages of our Validation Toolkit and give it a try. The excerpt here gives you a good sense of how easy the OPQ process can be.
The full document, of course, includes all functions of the medAspis Lean FMD system. Get in touch.
Your FMD Speed Scanner no longer works? We will send you a replacement unit free of charge so that you can continue work as quickly as possible and thus ensure operability. You will automatically receive a return label for the defective unit, too.
You will receive the replacement unit regardless of whether your warranty is still valid. If the warranty has expired, we will find a cost-effective solution for you.
Companies in the pharmaceutical industry are validated and meet strict quality requirements. Nevertheless, there is still a significant compliance risk with FMD.
Suspected falsification cases may not be handled and documented in a GxP-compliant manner.
With our free, anonymous and non-binding Compliance Check-up, we analyse and assess your company’s critical FMD error messages.
Based on your existing FMD audit trails, we analyse among other things:
The analysis is performed entirely within your data system. No data is transmitted to medAspis. All evaluations remain anonymous.
Request your free, no-obligation trial.
We will contact you personally to discuss the next steps.
Download the error messages directly to your computer in your local language.
Can’t find your language? As soon as you become a customer, we’ll of course provide the error messages in your local language. Promise.
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medAspis Lean FMD covers all requirements for connecting your company to the NMVS responsible for you for the purpose of falsification checks in accordance with the EU Falsification Directive 2011/62/EU and Delegated Regulation (EU) 2016/161.
And much more…
The mobile FMD Speed Scanner is extremely user-friendly with its touchscreen and is full of surprises. Here are some of its features explained:
Scanning continues even without internet. Codes are stored and processed later.
Monitors batches and products in real time and reports deviations immediately.
The scanner stops instantly on error. Scanning continues only after confirmation.
A control number shows missing packs instantly. Just rescan the last row – everything is recorded.
The scanner scans while the server verifies in the background for maximum speed.
Duplicate scans are detected and filtered automatically – no manual checks required.
Das medAspis Lean FMD System ist das Gehirn hinter dem FMD Speed Scanner. Hier werden alle Scan-Ergebnisse gesammelt und weiter verarbeitet.
PIN-protected profiles control access and allowed FMD functions securely.
All scan data is available for further processing and export.
System interface and NMVS messages are displayed in your local language.
Packs, cartons and pallets are logically and transparently linked.
Aggregations can be shared easily or provided to customers.
Groupings with a unique aggregation code for secure processing.
Links packs with delivery note, customer or carton.
Original codes and full NMVS responses are stored completely and permanently.
Web service interface for direct access to all system data in JSON format.
All scan data is archived for at least five years.
Verification is performed directly at scan via NMVS with instant feedback.
Custom reports by product, batch or time period.
Complete overview of all FMD activities as an audit trail.
Central system control with access to all data.
mit medAspis Lean FMD können Sie auf kritische Fälschungsalarme reagieren. Fehlalarme werden verhindert, die übrig gebliebenen kritischen Fälle werden sicher erkannt und können verarbeitet und dokumentiert werden.
Expert support for all questions related to counterfeit alerts.
Structured documentation of all critical alerts.
Clear instructions for operators and supervisors in every alert case.
All critical alerts clearly displayed in the control panel.
All critical situations explained clearly at a glance.
Additional verification before decommissioning returned packs.
Zeitfenster bis zu 2 Stunden – ideal für Pausen und Schichtwechsel.
medAspis Lean FMD is used throughout the entire pharmaceutical distribution chain, from the manufacturer to the wholesaler to the local pharmacy or hospital. Parallel distribution also relies on medAspis due to its high speed.
Here in the FMD Briefings, we explain how medAspis Lean FMD is usefully integrated into your daily workflow.
And how to get the data into your own IT landscape.
We are proud to present some typical applications used by our customers. If you have any other ideas, please contact us. We can make almost anything possible.
Our customer is one of Europe’s largest pharmaceutical logistics companies. medAspis Lean FMD was chosen for its extremely high scanning speed and flexibility.
medApsis Lean FMD is fully integrated into the customer’s own WMS; the entire FMD process runs seamlessly in operations and is controlled entirely by the WMS.
Even the scanning process is carried out using customer-certified handheld scanners, with the medAspis software specifically adapted to ensure a consistently high scan rate.
Our customer is one of Europe’s largest pharmaceutical logistics companies. medAspis Lean FMD was chosen for its extremely high scanning speed and flexibility.
medApsis Lean FMD is fully integrated into the customer’s own WMS; the entire FMD process runs seamlessly in operations and is controlled entirely by the WMS.
Even the scanning process is carried out using customer-certified handheld scanners, with the medAspis software specifically adapted to ensure a consistently high scan rate.
Our customer is one of Europe’s largest pharmaceutical logistics companies. medAspis Lean FMD was chosen for its extremely high scanning speed and flexibility.
medApsis Lean FMD is fully integrated into the customer’s own WMS; the entire FMD process runs seamlessly in operations and is controlled entirely by the WMS.
Even the scanning process is carried out using customer-certified handheld scanners, with the medAspis software specifically adapted to ensure a consistently high scan rate.
Our customer is one of Europe’s largest pharmaceutical logistics companies. medAspis Lean FMD was chosen for its extremely high scanning speed and flexibility.
medApsis Lean FMD is fully integrated into the customer’s own WMS; the entire FMD process runs seamlessly in operations and is controlled entirely by the WMS.
Even the scanning process is carried out using customer-certified handheld scanners, with the medAspis software specifically adapted to ensure a consistently high scan rate.
A leading pharmaceutical logistics provider uses medAspis Lean FMD because of its high scanning speed and flexibility. Fully integrated into the WMS, including the customer’s own scanners, the FMD process runs seamlessly in operation.
Our customer is one of Europe’s largest pharmaceutical logistics companies. medAspis Lean FMD was chosen for its extremely high scanning speed and flexibility.
medApsis Lean FMD is fully integrated into the customer’s own WMS; the entire FMD process runs seamlessly in operations and is controlled entirely by the WMS.
Even the scanning process is carried out using customer-certified handheld scanners, with the medAspis software specifically adapted to ensure a consistently high scan rate.
Omeprazole is over-the-counter, but subject to FMD. Through medAspis aggregation, wholesalers scan these medicines in advance. This keeps processes fast, FMD-compliant and cost-effective.
Our customer is a mail-order pharmacy that exclusively sells over-the-counter medicines, including omeprazole. Although available without a prescription, omeprazole is subject to FMD requirements. Due to low demand, the necessary scanning process places a strain on the pharmacy’s highly optimised operations.
To increase efficiency, the pharmacy obtains omeprazole in aggregated form via the medAspis aggregation system. The wholesaler scans the packs in advance, delivers them bundled, and labels the cartons with a medAspis aggregation label. Upon goods receipt, the pharmacy simply scans this label; the packs inside are automatically deactivated in an FMD-compliant manner.
As a result, omeprazole can be integrated into the mail-order pharmacy’s regular processes without individual scanning. Aggregation has only a minimal impact on wholesalers and significantly simplifies pharmacy processes – with a clear cost advantage.
For internal transport, medAspis aggregation enables rapid FMD verification at goods receipt. One scan replaces thousands of individual scans – secure, fast, and without re-capturing.
Our customer operates branches throughout Europe. Internal goods movements are also subject to FMD verification. The medAspis aggregation system enables considerable time savings.
The packs are scanned in the outbound warehouse and stored in the Lean FMD system. When goods are received in other countries, the data is retrieved from the shipping carton or pallet using an aggregation code – without the need for rescanning.
Aggregation works across all packaging levels: medicine pack, carton and pallet. A single scan of the pallet label captures all contained cartons and packs, replacing thousands of individual scans. The aggregation code is transport-secure and cannot be used by third parties.
A parallel distributor uses medAspis for FMD verification and batch control in a single scanning process. The FMD Speed Scanner automatically stops when the target quantity is reached – for complete, batch-pure bundles.
Our customer operates in parallel distribution in Southern Europe and purchases medicines from pharmacies and wholesalers. The packages are assembled into batch-pure bundles on an order-by-order basis and delivered to parallel importers in Northern and Western Europe.
medAspis enables simultaneous FMD status verification and automatic batch control in a single scanning process. The target quantity is defined in the Control Panel, and the FMD Speed Scanner automatically stops when the target quantity is reached. This ensures that the correct number of identical products and batches are always delivered.
A parallel trader uses medAspis Lean FMD for secure destruction. Save Dispense first checks the status and only deactivates active packs – preventing false alarms and suspicion of counterfeiting.
Our customer operates in parallel distribution and specialises in narcotics. These are subject to particularly strict regulatory requirements and must be sorted out and destroyed more frequently than average – including FMD deactivation.
Since many packs have an unknown FMD status, incorrect deactivation quickly leads to reports of suspected counterfeiting. With medAspis Lean FMD and the Save Dispense function, the current status of each pack is checked first. Active packs are correctly marked as destroyed, while those that have already been deactivated remain unchanged. This prevents false reports.
The integrated reports enable customers to document all processes transparently for the supervisory authorities.
A parallel distributor transfers FMD scan data directly into SAGE via aggregation. All serial numbers are imported automatically – for reporting and customer communication.
Our customer operates in parallel distribution and transfers all relevant FMD scan data into the SAGE ERP system for further processing.
To achieve this, the customer uses Lean FMD’s aggregation function. All serial numbers are scanned and aggregated at goods-in. In a second step, the SAGE system identifies the aggregation codes on the carton labels and retrieves the data via the IT interface from Lean FMD. All serialisation data is automatically transferred into SAGE for reporting and customer information.
A parallel importer uses serialisation to assign each pack to a customer. Returns are only accepted if the delivery was previously made to that specific customer.
Our customer is a parallel importer that delivers directly to pharmacies. The high-priced products are scanned and serialised before shipping and clearly assigned to a customer.
In the case of returns, checks are carried out to ensure that the pack was actually delivered to this customer beforehand. Only confirmed deliveries are accepted as returns; otherwise, acceptance is refused. This reliably prevents misuse and false returns.
An international generic drug manufacturer supplies German hospitals with data accompanying the goods. medAspis provides hospitals with the aggregation module free of charge.
Our customer is an international generics manufacturer. For supplying German hospitals, an aggregation process compliant with the German “accompanying data delivery” regulation has been implemented. Hospitals receive already serialized packs and no longer need to scan them.
As many hospitals are not yet able to use aggregation systems, medAspis provides its aggregation module free of charge so they can also benefit from scan-free deliveries from this manufacturer.
A Spanish wholesaler supplies ambulances with medicines via affiliated pharmacies. The logistical process is simplified through aggregation.
Our customer is a Spanish wholesaler supplying prescription medicines to on-site medical units via a network of local pharmacies, in line with national regulations.
With the introduction of the Falsified Medicines Directive, pharmacies would normally need to scan and deactivate each pack individually. To reduce this workload, the wholesaler delivers pre-scanned, aggregated shipments. Pharmacies only scan the aggregation code on the carton, and all contained packs are automatically deactivated in an FMD-compliant manner.
A Polish wholesaler uses medAspis Lean FMD for hospital aggregation. A single scan automatically transfers and deactivates all serial numbers – a simple process and an advantage in tenders.
Our customer is a Polish wholesaler using medAspis Lean FMD to provide aggregated codes for hospital deliveries. In Poland, hospital supply contracts are awarded via tenders, where offering aggregation is a strong competitive advantage.
With aggregation, hospitals no longer need to fully scan deliveries. They simply scan the carton aggregation code, and all serialisation data is automatically transferred and deactivated. The medAspis system is already widely used in Poland by leading wholesalers.
A French exporter uses medAspis for aggregation. A scan of the aggregation label marks all packs as exported – if they are canceled, they can be reactivated by scanning them again.
Our customer is a French exporter supplying EU-approved medicines to Africa. The French packaging can be used directly in many African countries without relabeling.
The products are often sourced from other wholesalers and are scanned and verified at goods-in. medAspis stores the serialisation data and aggregates each carton with an aggregation label. At export, a single label scan marks all contained packs as exported. If an order is cancelled at short notice, the packs can be reactivated by scanning the label again.
A Spanish spot trader delivers pre-scanned goods with an aggregation code. A scan automatically transfers all serial numbers of a pallet to the customer’s system – quickly, completely and without individual scans.
Our customer is a Spanish spot trader acting as an intermediary and leveraging price differences within the domestic market. To make his goods more attractive, he pre-scans all packs and transmits the serialisation data together with the shipment.
At goods-in, the recipient only needs to scan the aggregation code attached to the outside of the pallet. This automatically transfers all contained serial numbers into their system – carton by carton, down to the individual pack. A single code is sufficient for complete data transfer.
A parallel importer uses Lean FMD for goods-in verification and re-serialisation. High-speed scanning, batch control, ERP integration and OBP registration ensure secure and efficient processes.
Our customer is a parallel importer. We support two key processes.
At goods-in, packs are verified, counted, and checked for batch consistency using high-speed scanning. Scan orders are loaded into our FMD system from Microsoft Dynamics Navision. Only if all data matches are the data transferred to the ERP and the goods put away. Before production, the status is checked again based on the stored data – without rescanning.
In the second step, all decommissioned packs are assigned new national serial numbers via labels. The packs are scanned per order and the new serials are registered via the onboarding partner (OBP).
A manufacturer serialises small quantities by hand labelling. medAspis Lean FMD scans the finished packs and transfers the data directly to the OBP – fast, flexible, and without its own serialisation line.
Our customer is a well-known manufacturer with a very small product volume. Setting up a dedicated serialisation line is not economical for these few packs. Instead, serial number labels are printed and manually applied to the packs.
With medAspis Lean FMD, the finished packs are scanned and the records are transferred directly into the manufacturer’s onboarding system (OBP). The customer particularly values the high scanning speed and the flexible use of the system for related projects.
Please allow up to 24 hours for your order to be processed. We will then send the newly generated Aggregation Codes as a PDF to the email address provided here.
Your FMD Speed Scanner no longer works? We will send you a replacement unit free of charge so that you can continue work as quickly as possible and thus ensure operability. You will automatically receive a return label for the defective unit, too.
You will receive the replacement unit regardless of whether your warranty is still valid. If the warranty has expired, we will find a cost-effective solution for you.
Do you suspect counterfeiting? Our medAspis Alert Team will assist you with the process. We are also happy to assist you with unclear error messages or unfamiliar situations.
Describe the incident using the report form. If needed, you can upload up to three photos. We will contact you as soon as possible and support you with the next steps.
Companies in the pharmaceutical industry are validated and meet strict quality requirements. Nevertheless, there is still a significant compliance risk with FMD.
Suspected falsification cases may not be handled and documented in a GxP-compliant manner.
With our free, anonymous and non-binding Compliance Check-up, we analyse and assess your company’s critical FMD error messages.
Based on your existing FMD audit trails, we analyse among other things:
The analysis is performed entirely within your data system. No data is transmitted to medAspis. All evaluations remain anonymous.
Download the error messages directly to your computer in your local language.
Can’t find your language? As soon as you become a customer, we’ll of course provide the error messages in your local language. Promise.
medAspis is committed to quality. Our customers rightly expect impeccable quality and comprehensible processes.
Our Validation Toolkit makes validation of our Lean FMD a breeze.
Simply download the first few pages of our Validation Toolkit and give it a try. The excerpt here gives you a good sense of how easy the OPQ process can be.
The full document, of course, includes all functions of the medAspis Lean FMD system. Get in touch.