Online Tutorial

Perform FMD operations

This section describes the main states the system can have when processing FMD operations. Similar functions are described only once. “exported”, “stolen”, “sample”, “free sample”, “locked”, “destroyed” are analogue to “dispense”. In this description, “dispense” is explained in detail, the subtypes work similar.

Verify

The FMD mode of the Speed Scanner is set to “verify”. The 2D matrix code of a pack is scanned. A “Verify” command is sent to the responsible NMVS.

A pack can be verified as often as required. A separate line appears in the Scan History for each “Verify” command. Packs with the same serial number can be scanned as often as required and each will be found in the Scan History.

The result of a “Verify” check can be negative.

In this case, the scanner is stopped, you can no longer scan, you have to take care of the alert. This process is documented by clicking the “Confirm” button on the Speed Scanner display. Analogously, this is noted in the Scan History.

In addition, the packs concerned are secured in the Speed Scanner. The packs can be checked in the alert list. When the errors are acknowledged, the “unsolved alert” counter is reset to zero.

Dispense

The FMD mode of the Speed Scanner is set to “dispense”. The 2D matrix code of a pack is scanned. A Dispense command is sent to the responsible NMVS.

The result can be positive or negative, just like “verify” and all other FMD operations.

The command “dispense” sets the status of the pack from “active” to “inactive”. A pack that is set “inactive” cannot be dispensed again.

A separate line appears in the Scan History for each Dispense command.

Double deactivation

Redispensing an already inactive pack will result in an NMVS error. This error may occurs very often because packs are dispensed several times due to carelessness.

Under certain conditions, the medAspis system recognises a dispensing as a duplicate and does not send it again to the NMVS. Instead, the result of the previous dispense is displayed again, but with the icon “Double Dispense”. The same entry is also displayed in the Scan History, again with the Double Dispense icon.

The condition for detecting a double is that the same pack has been deactivated with the same FMD command within the last 10 minutes.

Double Dispense Filter is switched off in certain situations

The Double Dispense Filter does not send the same FMD operation (Disable, Export, Stolen, Destroy, Probe, etc.) to the NMVS for rechecking for a set period of time (10 minutes in the default or two hours in Alert Guard).

However, there are results for which this time delay is a disadvantage. For example, if the NMVS system is unavaila-ble for a short time, the double-dispense filter is turned off and another FMD operation is possible immediately.

The double-dispense filter is also switched off for login operations (login, password entry, etc.).

Reactivation

The FMD menu of the Speed Scanner is set to “reactivate”. The 2D matrix code of a pack is scanned. A reactivation command is sent to the responsible NMVS. It is not necessary to specify the original FMD operation to be reset now. This attribute, which is necessary for the NMVS, is automatically added to the reactivation command by medAspis system. Excluded from this are the statuses “marked as stolen” and “marked as destroyed”. The NMVS system don’t allow to reactivate those statuses.

Reactivation resets the status of the pack from “inactive” to “active”. For various reasons, this operation can be negatively acknowledged. Then an error message appears.

The reactivation is displayed as a separate line in the Scan History.

Manual input

If a 2D matrix code cannot be scanned by the scanner, the data can be entered manually. To do this, the predefined fields must be filled in and the required FMD operation must be specified.

If an expiry date has only year and month, the day in the display is either left blank or filled with 0 (zero).

The NMVS response appears again on the main screen of the FMD Speed Scanner.

In the Scan History, the manual display is not specially marked. The FMD command resulting from the manual input is displayed exactly as if it had been generated by the scanner.

Offline Mode

A permanent internet connection from the hand-held device to the medAspis server is necessary for the unrestricted function of the Lean FMD system. All scanned data records are immediately sent from the handheld device to the server, where further processing takes place.

If the internet fails, this processing is disrupted. There are many reasons for a broken connection: The handheld scanner or the server are not working correctly, a malfunction at the internet provider, technical faults or changed settings in the local wi-fi router.

In such cases, the hand-held device indicates the loss of the Internet connection and records all data sets. The offline status and the number of data records temporarily stored in the device are displayed in the field at the bottom right.

As soon as the Internet connection is re-established, all stored data sets are automatically transferred to the server.

ATTENTION: The data is not processed on the server immediately. Manual intervention is required to perform the originally desired FMD operations.

Lean FMD with all the trimmings

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…

Our FMD Speed Scanner

The mobile FMD Speed Scanner is extremely user-friendly with its touchscreen and is full of surprises. Here are some of its features explained:

Offline

Scanning continues even without internet. Codes are stored and processed later.

Batch Control

Monitors batches and products in real time and reports deviations immediately.

Stop on Error

The scanner stops instantly on error. Scanning continues only after confirmation.

Complete Capture

A control number shows missing packs instantly. Just rescan the last row – everything is recorded.

Scan Accelerator

The scanner scans while the server verifies in the background for maximum speed.

Double Scan Filter

Duplicate scans are detected and filtered automatically – no manual checks required.

Our Lean FMD System

Das medAspis Lean FMD System ist das Gehirn hinter dem FMD Speed Scanner. Hier werden alle Scan-Ergebnisse gesammelt und weiter verarbeitet.

User Management

PIN-protected profiles control access and allowed FMD functions securely.

Open data concept

All scan data is available for further processing and export.

Local Language

System interface and NMVS messages are displayed in your local language.

Hierarchical Aggregation

Packs, cartons and pallets are logically and transparently linked.

Export Aggregations

Aggregations can be shared easily or provided to customers.

Aggregation

Groupings with a unique aggregation code for secure processing.

Groupings

Links packs with delivery note, customer or carton.

Raw data is retained

Original codes and full NMVS responses are stored completely and permanently.

IT Interface

Web service interface for direct access to all system data in JSON format.

Long-Term Data Storage

All scan data is archived for at least five years.

FMD in Real Time

Verification is performed directly at scan via NMVS with instant feedback.

Reporting

Custom reports by product, batch or time period.

Scan History

Complete overview of all FMD activities as an audit trail.

Control Panel

Central system control with access to all data.

Our powerful
Alert mManagement

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.

Alert Team

Expert support for all questions related to counterfeit alerts.

Alert Reporting

Structured documentation of all critical alerts.

Handling Instructions

Clear instructions for operators and supervisors in every alert case.

Alert Overview

All critical alerts clearly displayed in the control panel.

Alert Poster

All critical situations explained clearly at a glance.

Safe Dispense

Additional verification before decommissioning returned packs.

Extended Double Scan Filter

Zeitfenster bis zu 2 Stunden – ideal für Pausen und Schichtwechsel.

Some of our customer references

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.

FMD Briefings: Further processing of scans

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.

Full integration into the WMS of a 3PL

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 from the mail-order pharmacy

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.

Delivery between own branches

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.

Parallel export in Spain

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.

Destroying large stocks

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.

Data transfer to SAGE

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.

Transparent returns processing

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.

Aggregation for Hospitals

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.

Medicines for company infirmaries

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.

Aggregation codes for hospitals

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.

French medicines for Africa

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.

Parallel export from Spain

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.

Working in parallel import

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).

Generating serial numbers

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.