MedTracS structure and operation
The role of the European Medicines Verification System (EMVS)
As a direct result of the FMD regulation, applied in the EU from the 9th of February 2019, all prescription medicines must undergo systematic origin testing before they are made available to patients.
In order to verify the authenticity of any medicine, the unique identifier of the medicine package has to be compared with the data of the unique identifier stored in the database of the National Medicines Verification Systems (NMVS).
Under law, to be able to check medicines protected with safety elements, national databases were created and are connected to each other.
The European Medicines Verification System (EMVS) was created and launched at the EU level, and is constantly being developed by the European Medicines Verification Organisation (EMVO). The development of each national database is organised and supervised by a national organisation set up by the relevant stakeholders at a national level.
Based on the regulation, only medicines with safety features can be marketed and distributed in the EU, the relevant data of which have been uploaded in the data storage systems and the safety features of which have been checked by the entities and persons obliged to do so during the process of distribution and sale to patients.
European Medicines Verification Organisation
https://emvo-medicines.eu/
National Medicines Verification Organisation
- Belgium: https://bemvo.be/
- France: https://www.france-mvo.fr/
- Hungary: http://humvo.hu/
- Luxembourg: https://lmvo.lu/
- Poland: http://www.nmvo.pl/
- Romania: https://osmr.ro/
- Slovakia: https://www.sool.sk
How MedTracS works
MedTracS offers full FMD functionality for all pharmaceutical wholesalers, hospitals and pharmacies that distribute small, average or very large volumes of medicines which need to be verified or decommissioned.
MedTracS performs all required FMD tasks and transactions based on the FMD regulation and the country specific guidelines and requirements.
MedTracS enables you and your staff to:
- verify the athenticity of the medicine pack in the national system and its saleability (in case the medicine pack was not obtained from the marketing authorization holder or a designated wholesaler),
- decommission the medicine pack from the national system when supplying or dispensing the medicine (pharmaceutical wholesaler, hospital, pharmacy, private healthcare institution),
- decommission the medicine pack from the national system when exporting it outside the EU (pharmaceutical wholesaler),
- decommission the medicine pack if it is being disposed of, its content was stolen, or it is submitted as an obligatory sample or supplied as a free sample,
- undo certain decommissioning operations.
How can MedTracS be configured?
MedTracS is a modern, high-quality system which we provide as a service to our clients.
It is suitable for large, medium and small organisations, from just a few to tens or even hundreds of terminals, all of which can be used simultaneously.
MedTracS can run on both mobile devices and computers
MedTracS is a highly flexible solution which takes care of various clients' hardware needs. MedTracS can be installed and operated on various types of scanning devices
- notebooks or desktop computers with connected wired or wireless scanners,
- mobile computer terminals,
- smartphones and tablets.
User-friendly, intuitive, and easy to learn
Thanks to its logical structure and user friendly intuitive interface, MedTracS software is easy to learn, so even users less experienced in IT systems can easily and quickly learn to use it.
Offered as a service
Scan the medicine identifier using the phone's camera or scanner. MedTracS application communicates with the server via an internet connection and forwards data from the scanned codes. MedTracS server verifies users, perorms connections and communication with the NMVS national systems.
Asynchronous connection for fast operation
To ensure fast operation, an asynchronous connection is used between MedTracS application and MedTracS server, so you don't have to wait for responses while using the application. Thanks to this solution, you don't need a fast Internet connection or a high-performance device because the actual work is done by the server, not by the user's device.
Very low investment needed
The investment cost of MedTracS can be incredibly low, even zero, as you don't need to buy software licenses and can install the MedTracS system on any existing devices (computer scanners and/or Android or iOS smartphones).
Start using MedTracS quickly and easily
To get started, you just need to set up one (or even several) smartphones running Android or iOS with Internet access. You can download the MedTracS application for free from Google Play or App Store, and you can start using MedTracS right away.
Safe and stable
A dedicated, safe, secure and stable operating environment (servers, databases) was developed for MedTracS, which uses certified interfaces to connect with National Medicines Verification Systems in the various EU countries. That means you can perform all your FMD transactions reliably, quickly, and securely.
You can use MedTracS in multiple locations
If you handle a high volume of medicines and your employees need to process a large number of medicine batches and packs, MedTracS can be installed and used in one or many divisions and locations. You can install the MedTracS application on as many user devices as you need, and you can always make any changes later. You can assign one or more users to each user device as required.
MedTracS can be used without an Internet connection
MedTracS works both online and offline. If you use MedTracS application and lose your Internet connection, you can continue your work. Your device stores the scanned codes in its memory. After the Internet connection is restored, MedTracS will send the data in batches for processing and provides you with responses and statuses received from the national system.
Activities based on authorisation levels
MedTracS executes user transactions and controls them based on permission levels and individual user rights. Each user has individual rights to access the system and perform transactions. You can configure the user rights at the start and change them later at any time.
Our dedicated focus is on customer satisfaction, which is why MedTracS includes innovative solutions that make transactions faster and easier.
Who is MedTracS ideal for?
If very fast and mass scanning of medicines is important
Speed, precision and tracking are very important for wholesalers, hospitals, logistical operators and companies which offer medicines depository and distribution services, where there are a huge amount of movements of medicines day by day, because every small shortfall or interruption may result in a loss of time and money.
With the LayerScan function, you can quickly verify or decommission hundreds or thousands of medicine packs, which increases efficiency, reduces scanning times, and simplifies and speeds up the work of your staff.
If you are looking for a simple and cost-effective solution
If you are a representative of a company or organisation with a lower pharmaceutical turnover, you may think that compliance with FMD requirements means a complex challenge and a high-cost burden.
Don’t spend money unnecessarily and don’t buy new devices, as your current equipment (desktop, laptop, smartphone) may still be able to satisfy the legal and technical requirements.
Contact us and see how easy it is to meet the requirements.
If you still have questions
MedTracS allows you to perform all required FMD tasks and transactions according to FMD regulations and country-specific legal and technical requirements in the area of medicines serialisation.
As a direct result of the EU FMD Regulation, applied from the 9th of February 2019, all prescrption medicines in the EU must undergo systematic origin testing before they are made available to patients.
Relevant regulations:
- Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products
- Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use
MedTracS functionality allows pharmaceutical wholesalers, hospitals and pharmacies to perform all the required FMD transactions, ensuring correct verifications and decommissions of medicines from the NMVS national system.
MedTracS was developed primarily for three market segments: pharmaceutical wholesalers, hospitals and pharmacies. Any type and size of company or organisation in these three segments can use MedTracS. In general, MedTracS can be easily used by any other organisation involved in the distribution of prescription medicines, from manufacturers to end users, e.g. health centres or doctors. If your business is outside of the 3 market segments mentioned above, please contact us to make sure that MedTracS can meet your FMD needs.
MedTracS currently can be used in the following countries of the European Union: Belgium, France, Hungary, Luxembourg, Poland, Romania, Slovakia.
Yes, with MedTracS you have continuous (24/7) access to the National Medicines Verification System.
For this access, your company/organisation must be registered in the National Medicines Verification System. If you need assistance with registration, please contact us and we will help and assist you.
We, the developers of MedTracS, are a certified FMD software provider. MedTracS has been tested and certified to comply with EU and national FMD regulations.
MedTracS is a high quality software solution and high quality service. Since February 2019, MedTracS is used successfully by a wide range of companies and organizations – small, medium and large. Please contact us directly and we will organize a meeting and detailed presentation of MedTracS and demonstrate how MedTracS can meet your needs and expectations. We can also arrange a free one-month trial period for you.
We offer full support including
- set up, configuration, installation and production launch
- operational usage and
- day-to-day operations.
Yes. MedTracS can be easily configured and launched at any time with your company’s valid certificate to access the National Medicines Verification System.
MedTracS can be installed on a laptop or computer (Windows operating system), mobile computer terminal (Android), tablet or smartphone (Android or iOS).
If your current hardware tools are capable of scanning two-dimensional datamatrix codes, you probably don’t need to purchase any additional devices. Please contact our team for support in testing your existing equipment. If you do not have the right devices, you may consider purchasing them. Feel free to contact us and we will help you choose the right tools. We cooperate as partners and authorized distributors with leading providers of high quality scanning equipment.
Typically we offer MedTracS for a fixed term such as 1, 2 or 3 years or for an indefinite period. We recommend to subscribe for at least 6 or 12 months, thus ensuring the continuity of client’s business processes and the stable operation. We provide special conditions and attractive pricing to our customers who choose MedTracS for the long term.
You don’t need to purchase a licence to install and use MedTracS. We offer MedTracS in a subscription model, based on a signed agreement between your company and us as the MedTracS provider.
Whether you are a pharmaceutical wholesaler, hospital, pharmacy or private healthcare institution, we offer MedTracS with functionalities and pricing that takes into account the needs and specifics of your company or organisation.
In case of large volumes of medicines verifications or decommissions, we highly recommended the LayerScan function, which will allow you to scan hundreds of medicines per minute.
Yes, MedTracS pricing depends on the country of your location. The fees for MedTracS subscription are billed in the local currency and according to the pricing scheme applicable in the country of client’s location. Depending on whether you are a pharmaceutical wholesaler, hospital, pharmacy or healthcare institution, MedTracS pricing may vary accordingly.
See for yourself just how easy it is to comply with FMD requirements!
