Will EU FMD be Enforced on Schedule?

Will EU FMD regulations be enforced on schedule, or will there be a delay? For pharmaceutical supply chain companies who sell product into Europe—particularly manufacturers, who have the longest prep time—that question is top-of-mind, with 6 months to go before the deadline. 

Read how Christoph Krähenbühl, Senior Director at 3C Excellis and long-time member of EMVO, and Allan Bowyer, TraceLink Industry Marketing Director answered that and related questions in a recent webinar.

1. Will there be an enforcement delay of EU FMD?

February 2019 stands.
- Christoph Krähenbühl

There is no indication of any delay to the enforcement of EU FMD. The deadline—as written in European law—is February 9, 2019, and that is the date to which EMVO (European Medicines Verification Organization) and the NMVOs (National Medicines Verification Organizations) are working. The only exceptions are Italy and Greece, who have an additional six years to transition from their existing serialization regulations to EU FMD. 

2. How will EU Member States enforce EU FMD if it’s not in their national law?

EU FMD has been transposed into national law in all EU Member States. It will be enforced by each Member State's National Competent Authority (NCA).

3. How can EU FMD be enforced if a National System isn’t ready?

At least 27 National Systems are expected to be live by the deadline.
- Christoph Krähenbühl

22 of the 30 National Systems are already in production, and only three are at risk of not being ready by February.

For MAHs, the readiness of National Systems does not alter their legal obligations to serialize products. Even if the National System of a country to which they ship products is not live, the product data must still be uploaded to the European Hub once the National System is live. This means that MAHs need to have implemented a serialization solution, and connected to the European Hub and any trade partners, by February 9, 2019.

It is true that if a National System isn’t live, wholesalers and pharmacists in that country will not be able to verify and decommission packs.

4. What will happen to an MAH if they fail to serialize their packs by February 2019? What’s the penalty?

The ultimate penalty is you won’t be able to sell your stock.
- Allan Bowyer

From February 9, 2019, MAHs who fail to serialize their packs will be in breach of the law. Legal opinions are being sought as to the exact consequences. However, the ultimate penalty is the rejection of your stock: if wholesalers and/or pharmacists can’t verify and decommission it, they can’t dispense it.

5. Will EU FMD be enforced in the UK after Brexit?

Yes. The UK has reiterated that it intends to comply with EU FMD after it leaves the EU. The Withdrawal Act will convert EU law into UK law, and preserve laws made in order to implement EU obligations. Regardless of the final decision, if a UK company sells its products in the EU, it is subject to EU enforcement.

6. How will stakeholders manage the presence of serialized and non-serialized packs on the market after February 2019?

EU FMD will be enforced for all stakeholders as of February 9, 2019, meaning safety features must be applied to in-scope packs manufactured as of that date, and those safety features verified and decommissioned. Packs released prior to February 9, 2019 without the safety features are not subject to enforcement and can still be dispensed. Over time, the availability of non-serialized packs will decrease and that of serialized packs will increase.

7. If medicines without safety features are released after EU FMD takes effect, who is legally responsible?

If a pack was released after February 9, 2019, by law it must bear safety features. The legal responsibility lies on the MAH: if an audit uncovers that a pharmacist has dispensed a pack that was manufactured after February 2019 without safety features, the repercussions will fall on the MAH, not the pharmacist. The pharmacist’s accountability is to verify and decommission all packs bearing safety features.

In practice, most EU Member States already require packs to display a lot or batch date, which the pharmacist or wholesaler could use to establish if a pack without safety features can still be legally dispensed.

Contact TraceLink to discover how we can help you be ready for the EU FMD deadline.