This means that
errors don't stand a chance.
errors don't stand a chance.
This means that
errors don't stand a chance.
errors don't stand a chance.
The 2019 Falsified Medicines Directive (FMD) makes it clear: any suspicion of falsification must be addressed, and any falsification must be removed from distribution. In order to meet the strict requirements of the authorities, companies from the pharmaceutical industry must act GxP-compliant at all times. And this concerns every single falsification alarm.
With Lean FMD and active Alert Management, medAspis has developed an advanced service that prevents virtually all false alerts to the authorities and processes the remaining cases according to the rules.
Falsification alerts arise in many day-to-day situations: e.g. packs are deactivated twice by mistake or goods are delivered that have already been deactivated. Depending on the scan volume, this can be hundreds of alerts per day. These cases of suspected falsification must be separated and, if necessary, manually checked and documented. That means a lot of work.
In addition, the authorities are always in the loop; they are automatically informed about every mistake and can still make critical enquiries 5 years from now. Do you have the right answers then?
A falsification alert indicates that a counterfeit medicine has been found or a possible falsification is present. Every single suspected case must be investigated. In terms of quality assurance and compliance, the following two cases are particularly important:
FMD scans are part of everyday work in pharmaceutical distribution. But so far, hardly any precautions are taken to reduce the numerous counterfeit alarms. Truly critical cases often get lost in the mass and are consequently not handled correctly.
Every single case is automatically reported to the authorities and debits your compliance account. Sooner or later, audits will take place – and the authorities will demand accountability for individual scans.
In principle, medicine packages suspected of being counterfeit must be separated. Because the next scan at your customer’s definitely leads to the same alert. The pack comes back and causes even more trouble.
medAspis has the entire FMD process perfectly under control. That’s why we enable not only extremely fast and efficient, but also virtually error-free processing.
The reason for the vast majority of false alarms is accidental multiple deactivations. medAspis Lean FMD identifies these and prevents almost all triggered false alarms. Our double scan filter reduces the number of alert messages to the NVMS that could trigger regulatory investigations to almost zero. Only the truly critical cases remain.
You can rely 100% on medAspis if an alert does occur. We provide all participants with exactly the information they need in their position. Clear, well structured, quality-assuring and productivity-promoting.
Instant scan stop in case of critical alerts. Our poster with clear handling instructions shows your employees: Is the alert critical? And what to do now?
medAspis provides supervisors with simple but precise explanations of all critical alerts: What are the next steps? What decision needs to be made now? What do the scanning staff need to know? All background information is easily accessible in our system.
The pharmaceutically responsible person and the quality managers receive all documents from medAspis in order to align SOPs and work instructions in the quality manual exactly according to NVMS and officially required procedures.
Despite all the training and well-intentioned advice, we know from experience that the scanning staff cannot always be relied upon and that suspected counterfeits are often lost in the day-to-day operations.
Our active alert management ensures that no counterfeit alert is overlooked. The suspected cases are clearly presented, and there are exact instructions for action for each individual case. Each case is clearly documented.
In order to systematically exclude more and more alert cases in the future, we are monitoring the findings of our alert team very closely. On this basis, we can help to optimise work processes and eliminate further sources of alerts in close consultation with you.
Assistance with all difficult cases: With our active Alert Management Programme, the medAspis Alert Guard Team is at your side with competence, experience and solution orientation.
With efficient scanning, a reduction of false alarms to almost zero and takeover of critical cases, medAspis is your 360° partner for FMD. With our service you reduce the amount of false alarms to the authorities to almost zero. We take care of all the rest. With Lean FMD, you can be sure that you are taking the best possible compliance and quality assurance measures at this moment.
Domande sull’FMD o sulla Lean FMD? Basta chiamarci o mandarci un messaggio.
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 throughput.
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.
Here in the FMD Briefings, we explain how medAspis Lean FMD can be usefully integrated into your daily workflow.
And how to transfer Data into the own IT landscape.
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 scanner, 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 operational mode 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 bulk via the medAspis aggregation system. The wholesaler scans the packs in advance, delivers them in bulk and labels the boxes with a medAspis aggregation label. Upon receipt of the goods, the pharmacy simply scans this label and the packs inside are automatically deactivated in accordance with FMD regulations.
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 in goods receipt. One scan replaces thousands of individual scans – securely, quickly and without re-entry.
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 rescan.
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 and batch-pure bundling.
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 packages – this prevents false alarms and suspicion of counterfeiting.
Our customer is active 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 scans the aggregation codes on the carton labels and retrieves the data via the Lean FMD interface. All serialization 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 and FMD-compliantly deactivated.
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 serialization 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 serialization data and aggregates each carton with an aggregation label. At export, a single label scan marks all contained packs as exported. If a deal is canceled 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 serialization data together with the physical shipment.
At goods-in, the customer only needs to scan the aggregation code on the pallet. This automatically transfers all contained serial numbers into the customer’s system — carton by carton, pack by pack. A single code is sufficient for the entire pallet.
A parallel importer uses Lean FMD for goods-in verification and re-serialization. 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 orders closed and transferred to the ERP. Before production, the data is verified again based on the stored records — 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 – quickly, flexibly and without its own serialisation line.
Our customer is a well-known manufacturer with a very small product volume. Setting up a dedicated serialization 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 data is transferred directly into the manufacturer’s onboarding system (OBP). The customer values the high scan speed and the flexibility of the system for related projects.