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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 decommission the medication before they administer them to the patients. In other words, pharmacists will have to 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 where it was initially performed, the medication has not expired or is registered in the national repository system as recalled, withdrawn, intended to be destructed or stolen and is done within 10 days from when the decommissioning was first performed.

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 the National Medication Verification Systems (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)?

The EMVS receives a Unique Identifier (UI) number from the manufacturer for each prescription medicine sold in Europe and act as a “router” to distribute them to the proper NMVS. The EMVS doesn’t act as a register or a verification system.

Is there any exemption from the EU FMD?

Article 23 of the EU FMD states that “Although Directive 2011/62/EU introduced provisions to regulate the sale of medicinal products at a distance to the public and mandated the Commission to establish the modalities of verification of the safety features by persons authorised or entitled to supply medicinal products to the public, 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”.

OPTEL Certa software questions


What data is captured by OPTEL Certa Software?

OPTEL Certa™ Software captures the Unique Identifier (UI) and transmits its information to the NMVS database of the country 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 removed automatically from the active list, and it can now 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, serial number and national reimbursement identification.

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 that have been given permission by the administrator of the OPTEL Certa Software solution at the pharmacy, hospital or vaccination center.

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 Bioptic 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 Bioptic 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.

Do you have integration with any of the major pharmacy robot providers? How do you link these robots?

We reuse the scanned data and manage the decommissioning through the OPTEL Gateway.


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