How Much Does it Cost to Register for EU FMD?
In the course of working with hundreds of companies across the pharmaceutical supply chain, we receive many questions on the upcoming EU FMD requirements. In this article series, we’ll answer one of your questions each week. This week, we look at the fees involved in registering for EU FMD, which will vary based on your company’s role and how quickly you sign up: early bird discounts are expiring soon.
The European Medicines Verification System (EMVS)
The EMVS, sometimes called the repositories system, is made up of a European Hub connected to National Systems (NMVS) for medicines verifications in the EU.
The European Hub
If you are the Marketing Authorization Holder (MAH) of an in-scope medicine sold in the EU, you will need to connect to the European Hub, which is managed by the European Medicines Verification Organization (EMVO), to upload product and serialization data.
EMVO charges an onboarding fee to each Onboarding Partner (OBP) for connecting to the European Hub. If your company is the MAH for multiple products, these can be managed in one OBP Portal.
Up until the 15th of January 2018, the early bird pricing ranges from €3,000-20,000 depending on the number of MAHs managed in one OBP Portal. On that date, the pricing increases by 50% until the 15th of June 2018, when it will increase by another 50%.
| # | Early bird | From 15th Jan 2018 | From 15th June 2018 |
|---|---|---|---|
| OBPs with > 12 MAHs | €20,000 | €30,000 | €45,000 |
| OBPs with 6-12 MAHs | €10,000 | €15,000 | €22,500 |
| OBPs with 3-5 MAHs | €8,000 | €12,000 | €18,000 |
| OBPs with 2 MAHs | €6,000 | €9,000 | €13,500 |
| OBPs with 1 MAH | €3,000 | €4,500 | €6,750 |
This is a clear incentive for companies to sign up as soon as possible. Time is fast running out to the deadline of February 2019, and lead times will inevitably increase as it looms closer. To sign up, the MAH does not need to provide details of how they will connect to the Hub or upload serial numbers, for example. EMVO just requires the brand details and the signature of the MAH’s Authorized Representative.
To start uploading data to the European Hub, the MAH will either need to do so manually, or have purchased or developed software to do so. If using software, this connection must be tested and certified by EMVO. TraceLink is one of a very small number of providers to already have a live, certified connection to the Hub, thereby saving you the time and risk involved. Find out more here.
National Systems
Each National System is maintained by a National Medicines Verification Organization (NMVO), who will levy fees. An MAH does not technically connect to the National Systems, but must pay a one-time registration and annual recurring fee to each NMVO where their products are on the market. This fee varies by Member State, number of MAHs, and in some cases by product volume or annual revenue. NMVOs are offering early-bird discounts of up to 50% off the onboarding fee.
If you will be involved in verifying or decommissioning medicines, for example as a wholesaler or dispenser, you will need to connect to the National System of every Member State in which that activity will take place, but there are no fees for establishing these connections.
Companies are advised to make contact with the NMVO of each applicable National System to find out how to register and the associated costs. TraceLink works closely with a number of NMVOs, and we will keep you updated on the latest developments in the run-up to February 2019.
If you want to learn more about the EMVS, watch this video.
Do you have a question about EU FMD that you’d like us to answer? Contact us and we’ll get back to you directly, and we’ll also create an article to help others who may have the same query.