What Happens to my Product Data if a National System isn’t Ready?
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 repercussions if a National System is not ready by the 9th of February 2019.
As part of EU FMD, Marketing Authorization Holders (MAHs) must upload their product master data and product pack data to the European Hub, which routes that data through to the National System of the market in which it will be sold. The product must be scanned and verified against the National System before being dispensed to a patient.
Will Product Pack Data be Stored in the European Hub?
National Medicines Verification Organizations (NMVOs) are at different stages of readiness. This has led some to question what will happen if MAHs are ready to upload product pack data to the European Hub, but the relevant National System is not ready to receive it. Do you wait until the National System is ready? Or will the data be stored in the European Hub in the interim?
The European Medicines Verification Organization (EMVO) has said that the European Hub is built to route product pack data, not to store it. However, the Falsified Medicines Directive is an EU-wide regulation: in order to comply with it, you must apply the mandatory information to all of your products, even if the National System in question is not yet operational.
Should a National System come online after the February 2019 deadline, EMVO’s current stance is that MAHs would have to retrospectively upload their product pack data once the relevant National System is ready to receive it. MAHs in this situation are obligated to store this data, keep track of when the National System goes live, and then upload it. This could have a large operational impact on your business if you sell into multiple markets.
Precisely what happens to products destined for a market without an operational National System as of the 9th of February 2019 would have to be agreed to between the EMVO and NMVO.
How TraceLink Helps
If you are using the cloud-based TraceLink EU FMD compliance solution, all your product pack data can be stored in your TraceLink repository. This eliminates the need to store and manage potentially vast amounts of product pack data on your servers and mitigates the risk of the data being lost or corrupted during downtime or system migration.
Once the National System is live, you can upload it to the European Hub from your TraceLink repository:
- The mandatory data elements for each market are automatically populated from your repository to ensure compliance.
- Our solution has a certified connection to the European Hub, and features bulk upload functionality.
- If you are aware that products have been decommissioned or removed from the market before that time, you can update their status in your repository before performing the upload.
Using our purpose-built compliance solution, you can can follow your standard serialization processes regardless of the status of the individual EU markets, and be ready and up-to-date as each NMVO is ready to accept product data. Find out more about our solution.
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.