The result
is a revolution.
Safe medicines.
Efficient processes.
With our Lean FMD, we protect the entire pharmaceutical supply chain from counterfeit medicines – from the manufacturer to the pharmacy.
We use state-of-the-art serialisation technology to verify the authenticity of prescription medicines. This ensures that only genuine medicines reach the patient.
Lean FMD
in everyday use
Our Lean FMD integrates seamlessly into existing processes and IT systems and reduces false alarms to an absolute minimum. This ensures you are fully prepared to comply with the European Falsified Medicines Directive (FMD):
Further processing of serialised data
Do you scan delivery notes or entire boxes and pallets? Do you report the scanned serial numbers to a customer? You can do all this with medAspis Lean FMD.
Whatever you have in mind, we’ve done it before – you’ll find examples in our many case studies and customer testimonials. Have a look.
FMD Briefings: Further processing of scans
In these FMD Briefings, we explain how medAspis Lean FMD can be effectively integrated into your daily workflow. We also explain how to import the data into your own IT system.
No false alarms in the FMD process
When the FMD process stalls, it is usually due to counterfeit alerts. Almost always false alarms.
Not with medAspis Lean FMD: our alert prevention system prevents false alarms. This gives you complete control over the FMD process.
Full FMD functionality
medAspis Lean FMD connects your organisation with the national verification centres (NMVS) to meet the requirements for authenticity verification in accordance with the EU Falsified Medicines Directive.
What’s more, Lean FMD integrates seamlessly into your specific operational processes.
There is a good reason why our Lean FMD is used in almost all sectors of the pharmaceutical distribution chain. From manufacturers to pharmaceutical logistics and wholesalers to local pharmacies and hospitals. Our Lean FMD is also used successfully in parallel distribution, clinical trials and the export industry.
We would like to outline a few typical applications here:
References and customer applications
If you have any other ideas, please get in touch. We can make almost anything happen.
Full integration with a warehouse management system
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 within the customer’s day-to-day operations and is fully controlled by their 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
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.
Easy delivery between own branches
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.
Automatic transfer of all serialisation data via the aggregation code
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.
When the goods arrive, the recipient simply scans the aggregation code affixed to the outside of the pallet. This automatically transfers all the serial numbers contained within – from the carton down to the individual pack – into their system. A single code is all that is needed for the complete data transfer.
Destruction of large stocks of unknown status
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.
Only accept own packages as returns
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 system for hospitals
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.
If a clinic does not use a standardised aggregation system, medAspis provides its aggregation module free of charge. This means that these clinics can also benefit from aggregation and process deliveries from this manufacturer without the need for additional scanning.
Pre-serialised medicines for company first-aid rooms
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.
Scan French medicines for Africa just once
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 imports: Simplified goods receipt and new serial numbers
Our customer is a parallel importer. We support two key processes.
In the goods-in department, the packs are verified, counted and checked for batch consistency using a quick-scan process. The FMD processes are fully integrated into the customer’s ERP system. Prior to production, a further status check is carried out based on the stored data – without the need for re-scanning.
In the next stage of the process, the deactivated packs are assigned new national serial numbers. The new labels are applied, and the packs are scanned and recorded on a batch-by-batch basis. Serial numbers are registered and uploaded via the onboarding partner (OBP) only for the packs that have been used.
Generating serial numbers
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.
Impressions from
the process chain
Our customers regularly send us videos describing their experiences with our FMD Speed Scanners. Whether for aggregation, scanning inverse codes (white codes on a black background) or through plastic foil.
Take a look for yourself:
Why not
give it a go yourself!
Experience Lean FMD under real conditions: free of charge, without obligation and in your own workflow. We give you access to our system, set up the connection to your NMVS and support you from the very first minute.
If you don’t like the FMD Speed Scanner (which, to be honest, we find hard to imagine), simply return the test unit.
First-class support:
We are here for you
It is important to us that you are able to work. Always.
That is why we are always at your service. Che si tratti di domande tecniche, problemi con il dispositivo o incertezze nella vita di tutti i giorni, il nostro team di assistenza è a disposizione per aiutarvi.
Scanner broken? Vi invieremo immediatamente un dispositivo sostitutivo. Non siete sicuri di un allarme? Our experts are on hand to assist you and provide clear answers. Avete dimenticato una funzione? Take advantage of our online tutorial – we explain everything step by step.
Il team di medAspis assicura che la vostra azienda rimanga operativa e che i processi FMD si svolgano senza intoppi. Always.
You are in Europe,
so are we.
medAspis is connected to all European NMVSs and has all the necessary approvals to connect you in your country at any time. With us, you can get started in no time.
We are waiting for you.
Why not give medAspis Lean FMD a try? Request a test scanner, we will set up system access for you, and you can get started. No obligation and free of charge.
FMD Briefings -
medAspis on YouTube
Are you familiar with our FMD briefings on YouTube? Here you will find all the secrets and background information about our Lean FMD.
Siete nuovi alla FMD o già esperti? Ce n’è per tutti i gusti.
Your compliance is a top priority for us
How many false alarms have you triggered today?
You may not know it, but the authorities do. And also the affected pharmaceutical manufacturer. FMD is a very special challenge, as internal activities are automatically transferred to locations outside your company.
medAspis is familiar with this situation and knows how to protect your compliance.
Our certificates for your protection
medAspis operates a quality management system (QMS) and is certified according to ISO 9001 (quality) and ISO 27001 (IT security). The QMS is set up to ensure compliance with Annex 11 (Eudralex, Chapter 4) is obtaining for our clients and is validated in accordance with Annex 15 of GxP.
medAspis offers a Validation Toolkit to facilitate testing and acceptance. It contains templates and test scripts for verifying and documenting operational and performance qualification (OPQ).
