Understanding the requirements of the EU FMD for wholesalers, which demands verification and decommission of products.
Verify & Decommission: EU FMD Transactions for Wholesalers
With the Falsified Medicines Directive (FMD) for the European Union (EU) coming into effect in less than one month, wholesalers must be aware of the requirements to implement the necessary safety features in pharmaceutical products.
The main objective of EU FMD is to assure the integrity of each product and its authenticity. This regulation ensures greater protection for patients preventing them from receiving illegal and undetected medicinal products.
Nonetheless, with an upcoming deadline, there are still some questions and uncertainties among wholesalers and distributors regarding the application of FMD. Now, take a look at some of the changes and key pain points to adopt and implement.
What is the Impact on Wholesalers and Distribution activities?
In short, the law specifies that wholesalers and distributors must verify medicinal products, especially products at higher risk of falsification, which pass through their process before supplying them to customers. This means that not only healthcare dispensers such as hospitals and pharmacies verify the authenticity of these products, but also wholesalers and logistics partners.
Although their impact in terms of complexity and investment is less than pharmaceutical manufacturers, the authentication process and secure distribution to consumers of these products also rely on their capability of compliance with this Directive.
Which are the Outlined Regulations for Wholesalers?
As detailed in Article 23, EU Member State may require the verification and decommission of medicinal products by wholesalers and distributors on behalf of their customers, including persons and institutions which are not supplied by a pharmacy or healthcare institution. For example, schools and universities, prisons, hospices, dental practitioners, veterinarians, nursing homes, optometrists and opticians, paramedics, armed forces, police, and any other governmental institution requiring medicinal products.
To comprehend which are the specific conditions to verify and decommission a pharmaceutical product, it is necessary to analyze them separately.
Verification & Authentication Process
At the beginning of the supply chain, manufacturers will upload master data of each product and pack they produce into the European Medicines Verification System (EMVS), known as the European Hub, which includes packaging, serialization and shipping information. Then, this data is shared with members of the National Medicines Verification System (NMVS). For example, those products that are intended to be supplied in Spain will be reported to the National Medicines Verification Organization (NMVO) of this country.
So, which are the requirements for wholesalers and authorized distributors? Once the master data is uploaded, they will use it to authenticate their possessed pharmaceutical products by scanning a two-dimensional barcode and comparing the unique identifiers (product code, batch number, serial number, National reimbursement number and expiry date) with their respective NMVS. Also, wholesalers must verify the integrity of the anti-tampering devices, inspecting those visual identifiers such as seals, labels, films, flaps, or any other pack technology, are still intact.
Ultimately, if medicinal products have been returned to wholesalers by authorized parties or another distributor, they should apply additional features of verification to ensure product integrity. Mainly, a double-check is required for those provided by persons who do not hold the marketing authorization.
In case of suspected falsification, that may indicate the product has been tampered with, or when the pack does not match with the data in the repository system, wholesalers shall not dispense it to the public. Particularly, they must report the problem to be investigated by entitled authorities.
When the unique identifiers have matched with the information held in the NMVS, there comes the last step of the supply chain for wholesalers and distributors known as the decommissioning process, where products must pass from active to inactive status.
Products and packs should be decommissioned in order to inactive their unique identifiers in the repositories system and prevent the distribution of falsified products to patients. For instance, those unique identifiers cannot be used a second time by illegal parties.
Decommission applies in cases when medicinal products have been:
- Dispensed or supplied to the public
- Distributed or exported outside the Union territory
- Reported as stolen
- Returned to wholesalers and cannot be resaleable
- Intended to be destroyed
- Requested as samples by healthcare competent authorities
- Set temporarily under investigation
Can a Decommissioned Product Change from Inactive to Active Status?
A product previously decommissioned can revert its status to active only in the following situations:
- The reversal operation is undertaken by the same person or operates in fulfillment with the same authorization premises as the person who decommissioned the unique identifiers.
- The reversal status takes place in less than a 10-day period after the decommissioning.
- The medicinal product has not expired.
- The pack has not been registered in the respective Hub as withdrawn, recalled, intended to be destroyed or stolen.
- The pharmaceutical product was not supplied to the patient or customers.
Must-know points in the verification process
Wholesalers and logistics partners are exempted from completing the process of verification in the next cases when the risk of falsification is minor:
- If the product is modified in terms of ownership but continues in possession of the same wholesaler.
- If two warehouses, which are associated with the same authorized entity, distribute medicinal products within the EU Member State, without selling them.
Which components are required to get ready for EU FMD application?
Wholesalers and distributors need two essential components for the correct application of the regulation:
- Technological devices that are capable to scan two-dimensional barcodes, such as hand-held mobiles, desktop scanners or imaging devices.
- A software application that connects with the NMVS for verification of unique identifiers.
How can Verifarma Wholesalers help to meet these EU FMD requirements?
Verifarma Wholesalers software application provides traceability solutions in verification and decommission of medicinal products in order to identify if those are authorized or falsified. Verifarma ensures and facilitates EU FMD compliance by authenticating medicine packs with the National Medicines Verification System (NMVS).
The application allows the scanning of a two-dimensional data matrix barcode placed in medicinal packs. Also, this process can be done manually by entering the serialization number.
During the decommissioning process, Verifarma software application offers an intuitive control over each status of the product: supply, export, intended for destruction, sample, locked, stolen, and there is a possibility to revert the status from inactive to active.
Verifarma Wholesalers provides different plans such as: Essential, Pro and Enterprise, which perfectly adapt depending on your business needs.
The implementation represents a great challenge for wholesalers that must adjust their procedures accordingly to FMD high safety standards. It is essential to understand the fundaments of this Directive, comprehending the impact and risks they will have to deal with, to guarantee the healthcare of the public.