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EU Falsified Medicines Directive related questions

 

Who does the EU FMD apply to and what are the implications?

The EU FMD applies to any healthcare institution, which is defined as a hospital, inpatient or outpatient clinic, or health centre. These institutions will be required to verify and decommission medications before they administer them to patients. In other words, pharmacists will have to authenticate and deactivate medications that were activated by manufacturers to provide a safe product to the patient.


Which countries are involved in the EU FMD?

There are 32 countries involved in the EU FMD, of which 28 are member states of the EU and four are members of the European Free Trade Area (Iceland, Norway, Liechtenstein and Switzerland). Belgium, Greece and Italy have a derogation until 2025 as verification systems are already in place in these countries. Belgium, though, has decided to not take up the derogation.


Where and when should the decommissioning take place?

The verification process can take place at any point throughout the healthcare supply chain; however, decommissioning must be performed before the medication is administered to the patient.


What does «Decommissioning» means?

Decommissioning means changing the status of a medication’s unique identifier stored in a country’s national repository system (NMVS) from active to inactive.


Is it possible to revert the decommissioned status of a unique identifier?

Authorised persons can revert the decommissioned status of a unique identifier as long as it’s done at the same location within 10 days of the initial decommissioning and the medication is not expired or registered in the national repository system as recalled, withdrawn, stolen or intended to be destroyed.


How is the decommissioning done?

To decommission a medication, you must have a solution that connects and exchanges data with the European Medication Verification System (EMVS), also known as the European Hub, and your country’s National Medication Verification System (NMVS). The EMVS will receive a unique identifier (UI) number from the manufacturer for each prescription medicine to be sold in Europe and act as a “router” to distribute them to the proper NMVS.


What is the National Medication Verification Systems (NMVS)?

The NMVS is a national system connected to the EMVS and administered by the authorities of the nation in question. Its role is to verify the authenticity of a product, ensuring that no falsified medicine can enter the supply chain.


What is the European Medication Verification System (EMVS)?

Also known as the European Hub, the EMVS receives a unique identifier (UI) number from the manufacturer for each prescription medicine sold in Europe and acts as a “router” to distribute them to the proper NMVS. The EMVS doesn’t act as a repository or verification system.


Is there any exemption from the EU FMD?

Although the EU FMD introduces provisions to regulate the sale of medicinal products at a distance to the public, Article 23 recognizes that “the supply of medicinal products to the public is still mostly regulated at the national level. The end of the supply chain may be organised differently in the different member states and involve specific healthcare professionals. It should be possible for the member states to exempt specific institutions or persons authorised or entitled to supply medicinal products to the public from the obligation of verification of the safety features, to accommodate the particular characteristics of the supply chain in their territory and ensure that the impact of the verification measures on those parties is proportionate”.

Examples of Article 23 health professionals and institutions include dental practitioners, optometrists and opticians, paramedics and emergency medical professionals, police, armed forces and other governmental organisations, institutions of higher education, prisons, schools, nursing homes, and veterinarians who administer human medicines to animals.


OPTEL Certa software questions

 

What data is captured by OPTEL Certa Software?

OPTEL Certa™ Software captures each product’s unique identifier (UI) and transmits its data to the appropriate country’s NMVS database to verify the authenticity of the product. It then receives an instant notification from the NMVS that shows if the product can be sold or not. If the medication gets a positive response, it is automatically removed from the active list (decommissioned) and can then be administered to the patient.


What is the Unique Identifier (UI)?

The unique identifier consists of the medication’s batch number, expiry date, product code and serial number. Depending on the legal requirements of the member state, a national reimbursement identification may also be included.


With OPTEL Certa™ Software, where does the data go?

The data only goes to the NMVS through the OPTEL Gateway. No data is shared with any third parties.


Who sees the data?

Only the people who have been authorised by the administrator of the OPTEL Certa Software solution at the pharmacy, hospital or vaccination centre can access the data.


Where is the information stored?

The data is secured in a cloud provied by Microsoft.


What is the difference between OPTEL Vertical Station and OPTEL Bioptic Station?

They both use OPTEL Certa Software, but the OPTEL Vertical Station is a movable device that can be placed anywhere in the pharmacy environment. OPTEL Bi-Optic Station is a stationary device that is installed in a specific location in the pharmacy as it provides two scanning surfaces, one of which is fixed to the counter. OPTEL Bi-Optic Station has a greater capacity for high-volume scanning.


How does the OPTEL Certa™ Software integrate with pharmacy systems?

OPTEL Certa Software integrates seamlessly into existing hospital and pharmacy IT infrastructures, connecting to the NMVS through the OPTEL Gateway, ensuring that the unique identifiers (UI) are sent safely and securely to and from the national database.


Can OPTEL Certa™ Software integrate with pharmacy robots that perform scanning operations?

Yes, Certa™ captures the data scanned by pharmacy robots and manages the decommissioning process through the OPTEL Gateway.


Can OPTEL Certa™ Software scan any type of barcodes?

OPTEL Certa™ was mainly designed to scan 2D barcodes but can scan all types of barcodes, as required by the EU FMD. If the barcode being scanned is not 2D, Certa™ will display the error message “EPC is invalid”. The transaction will nonetheless be successfully registered in the system.


If the hardware breaks, how fast can it be replaced?

Spare equipment is kept in Limerick, Ireland, for quick replacement. The turnaround time is usually between 48-72h depending on the location.


Is there any emergency option or procedure in place if the hardware is not available to ship?

In case of an emergency, OPTEL will assist the customer to access OPTEL Certa™ Software from another workstation. If the scanning equipment is not available, manual entry is possible.

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