Congratulations, you’ve just connected to the EU Hub and you are authorized to begin uploading production data ahead of the February 9, 2019 deadline. It’s been a long road. Most pharma marketing authorisation holders (MAH) report taking six months from initial onboarding application to authorization. Now what?
You are now free to begin applying the two safety features to your prescription drugs marketed in the EU and upload the data about them to the EU Hub. But what if you already began applying the safety features to your products some time ago? What do you do with all that data for previous shipments of serialized drugs?
The answer is tucked inside of a slightly obscure question contained in the European Commission (EC) FMD Q&A document. Question/Answer 1.12 is:
“1.12. Question: Would it be possible to place a unique identifier on the packaging of a medicinal product during the 3 years period between the publication of Commission Delegated Regulation (EU) 2016/161 and its application?”
“Answer: Yes, on a voluntary basis. It is recommended that, whenever possible, unique identifiers are placed on the packaging only once a functional national/supranational repository allowing the storage, verification of the authenticity and decommissioning of those identifiers is in place. Unique identifiers which are placed on medicinal products before such repository is in place are expected to be uploaded in the repository as soon as it becomes operational.”
That last sentence contains the answer to our question, although it may not be obvious. The “repository” they are talking about is the National Medicines Verification Systems (NMVS) that covers the EU Member State your products were shipped to. According to the European Medicines Verification Organization website, as of the moment I am writing this, all of these national repositories except Italy, Greece, Liechtenstein, and non-EU member, Switzerland are accepting production data from the EU Hub.
To get your data to the operational national repositories, you need to upload it to the EU Hub. But, because you should only send data to the EU Hub that is destined to a national repository that is able to receive production data, you must continue to withhold data for serialized product that has been shipped to those countries I listed above (but by the time you read this, those countries may be operational, so check their website).
So, your initial upload of data to the EU Hub should contain all data for previously serialized product shipped to all operational countries participating in the FMD, and it should be sent as soon as you get connected. After that, you should monitor the EMVS website so you can learn when those last few countries are ready to receive your data and upload your data for those countries after each are announced.
What if you haven’t been shipping serialized product before you were connected to the production EU Hub? In this case, you won’t have a backlog of data for previous shipments. You just need to start uploading the data for future shipments of serialized products as you make them. Just remember to hold back on the countries that are not yet ready to receive their data at that time.
Communication with the EU Hub is so much more than just uploading serialized product shipment data, as you should have learned during the onboarding process. Beside just receiving data, each national repository is in a slightly different state of capability, depending on which vendor that country is using to operate their national repository. You can see what functionality was available on October 5, 2018 in the NMVS Functionality Matrix v1.0 on the EMVO website.
BTW, since I posted my essay “How Will They Delay The FMD?“, I have heard from several people who are more connected with the progress of the FMD than I am and they refute the likelihood that the FMD will be delayed at all. We’ll find out soon.