Falsified Medicines Directive - FMD

On 9 February 2019 the FMD comes into force, a European directive aimed at preventing counterfeit medicines from entering the supply chain.

This means that each individual pharmaceutical package delivered within the European market must have a security seal and a unique serial number, a so-called 2D data matrix, sometimes referred to as a 2D barcode. The pharmaceutical company (the marketing authorisation holder, MAH) must provide each individual package with a 2D data matrix and a security seal to prevent tampering and counterfeiting.

Pharmacies, county councils, hospitals and other healthcare providers are responsible for checking that each pharmaceutical is genuine and unopened before dispensing it. This is done by verifying the package's 2D data matrix in the Swedish Medicines Verification System (SMVS) and checking that the package's security seal is intact.

What are MAHs doing?
The MAH of a prescription medicine must provide each individual package with a 2D data matrix and security seal to prevent tampering and counterfeiting. The 2D data matrix must include the following information: GTIN/product number, serial number, batch number and expiry date.

The MAH must register the 2D data matrix in the European database (EMVS), which result in corresponding update in the Swedish national database (SMVS). Each individual 2D data matrix enables the package's ID to be checked before being dispensed to a consumer.

When MAHs starts to label their packages with 2D-codes, these codes must be uploaded to the European database (regardless of the date of February 9, 2019) in order to enable decommissioning if the package is dispensed after February 9, 2019.

It is important that the MAH enters Tamro as the designated wholesaler for the Swedish market when registering packages in the European database.

Tamro's GLNs

What are pharmacies doing?
When dispensing medicines to consumers, pharmacies are responsible for decommissioning the 2D data matrix in the SMVS and checking that the security seal on the pack is intact.

What are hospitals doing?
Hospitals are responsible for decommissioning the 2D data matrix in the SMVS for all packages they use and for checking that the security seal of each package is intact.

What is Tamro doing?
Tamro is ready to comply with and manage all legal requirements of the FMD. In spring 2018, Tamro participated in a pilot project to verify and test our processes. Parallel to this, we have secured all the necessary IT connections.

Tamro will act only in the event of a discrepancy, that is if outer packaging, boxes or packages are damaged, such as damages discovered in goods receiving. In the event of a discrepancy, Tamro will always contact the MAH for a decision on further action. If agreed, Tamro will decommission pharmaceuticals delivered to non-pharmacies.

Tamro's Services
Tamro offers the following FMD-related additional services:

• Service Verification Test SMVS, Order Form Verification Test for SMVS

Here are a few examples of procedures affected by the FMD.

Goods in stock
When the FMD comes into force, Tamro, pharmacies and county councils will already have goods in stock. This means that during a transition period, the supply chain will include packages with neither a security seal nor a 2D data matrix registered in the SMVS that are still approved since they were delivered before 9 February 2019. Depending on the expiry date and turnover of each package, they will remain in stock for varying periods.

Returns to Tamro
In the case of returns of saleable prescription medicines, Tamro will verify that each product remains commissioned in the SMVS and as such can be returned to saleable stock.

Recalls
The packages will be decommissioned.

Damaged products
The packages will be decommissioned.

Expiry date passed
The packages will be decommissioned.

Destruction
The packages will be decommissioned.

Vaccines
When delivering vaccines, we offer to decommission each package in the SMVS.

Deliveries to other wholesalers
No decommissioning is implemented as the products are not being dispensed to consumers.

Deliveries to other EU countries
No decommissioning is implemented as the products are not being dispensed to consumers.

Deliveries outside the EU
Decommissioned by Tamro as the goods are leaving the EU.

Deliveries to non-pharmacies
As per the regulations, the healthcare provider (the goods recipient) is responsible for decommissioning in the SMVS. Tamro will offer a service wherein we take care of decommissioning in conjunction with delivery.

You can read more about the FMD on the e-VIS website, https://e-vis.se/en/