We Show you
what Lean FMD
all about: Everything
what Lean FMD
all about: Everything
We Show you
what Lean FMD
all about: Everything
what Lean FMD
all about: Everything
With Lean FMD, you have a solution at hand that meets all requirements of the FMD directive at its best. Right down to a clever system for error management. Even with extremely high scanning loads, Lean FMD fits perfectly into the daily work routine. Because Lean FMD is extremely fast – offering up to 13,000 scans per hour.
We looked at many industries and learned about the respective pain points. Lean FMD was developed from the beginning with the aim of supporting existing workflows and processes in your company.
The standard application of Lean FMD is the verification and deactivation of medicinal products. With the medAspis system, all locations can be served where even a single 2D matrix code needs to be scanned.
Lean FMD already pays off when only small quantities are scanned – e.g. in pharmacies and hospitals. But it’s where huge quantities of packages are involved that things really get interesting. With Lean FMD you can process up to 13,000 packs per hour.
Plus, you are extremely flexible when it comes to scanning. Because the speed scanner is mobile and works without cables. This means that you can, for example, also scan in cold storage rooms or other difficult-to-access facilities.
As a rule, medicinal products are dispensed to patients by the manufacturer via wholesalers and a public pharmacy or a hospital pharmacy – sometimes with the aid of a pharmaceutical logistics provider.
However, there are cases in which medicinal products are not dispensed by pharmacies but are supplied directly by the manufacturer, the logistics provider or wholesalers. These cases are regulated in the Delegated Regulation (EU) 2016/161 in §23.
§23 includes e.g. veterinarians, dentists, ambulance and emergency doctors, armed forces and police. It also comprises research and university, prisons, schools, hospices or nursing homes.
Wherever large quantities of medicinal products are produced and processed, larger quantities must be destroyed from time to time. The cause can be production or storage errors – just as well as a new pack design or new regulatory requirements.
These activities usually take place sporadically, whenever a larger quantity has accumulated.
Some customers store the goods to be destroyed and would like to destroy them in one go. In these cases, we temporarily provide speed scanners in order to process the stock quickly.
Returns are a critical issue. Often, medicines returned as returns cannot be used any further. That is why returns are checked in particular detail. This makes it possible to avoid receiving drugs that do not originate from the company’s own supply.
With the Falsification Directive, this check has become easier. With medAspis, you ensure which serial numbers were sent to which customers and can check the returns accordingly.
In many production and trade steps, single-variety processing is mandatory. For parallel trade in particular, it is a priority that packs with wrong batch numbers or even wrong product codes do not accidentally find their way into otherwise homogeneous deliveries.
The medAspis Batch Control module prevents unwanted capture of incorrect packs.
Once Batch Control is activated, the user will be alerted as soon as a wrong batch is captured. Incorrect batches are not taken over into the current production.
With Lean FMD from medAspis, data can be captured, stored and transmitted to third party systems very quickly. The data do not necessarily have to be checked at an NMVS.
Aggregation refers to the grouping of serial numbers with the aim of processing them in bundles. Aggregation is not part of the standard of the European Falsification Directive.
medAspis has created an easy-to-use aggregation system to make work significantly easier in typical applications.
According to the EU Commission, the supply of aggregated goods to hospitals is expressly permitted.
medAspis has developed a complete system with which
The hospital pharmacist just presses a button – and the entire delivery is transferred to the hospital stock. Now all products can be checked out without the need for ever scanning a single product – the epitome of labour saving.
medAspis is at home in the German WBDL (Warenbegleitende Datenlieferung) system and also in Poland, where hospitals are supplied by wholesalers
Often, serial numbers of packs are needed several times.
For example, complete cartons are scanned and stored in the incoming goods department for the prescribed verification. Later, these cartons are processed further, for example, to be exported or processed into new products for the national market at the parallel importer. For these cases, the serial number must be captured anew.
But not with medAspis – here it is sufficient to scan data once. The serial numbers already stored in the first step are simply used again to perform the FMD operation of the second step.
Buyers are not always 100% reliable: Deals will still fall through even when goods are already on the loading bay.
With the Falsification Directive, business has become even more difficult: If complete pallets and cartons full of medicine packs have already been scanned and deactivated for export, and then are not collected after all, they have to be reactivated again at great expense. And this has to be done within ten days. Otherwise, reactivation is no longer possible and the status can no longer be changed.
With medAspis Late Check Out, this problem is a thing of the past. Cartons are recorded once – for example when they are delivered to the goods receiving department. The serial numbers are permanently stored for these cartons or pallets.
If export is now pending, the entire delivery is only marked as exported when it is clear that the transaction is actually taking place. If necessary, even after the goods are already on the truck. And this works simply at the touch of a button.
Aggregated data can also be used beyond hospital business or internal optimisations. Suppliers can take the scanning burden off their customers and reap economic benefits.
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.