Disconnecting the British system from EMVS

Information for Czech pharmacies, wholesalers, and marketing authorization holders from the perspective of FMD related to the departure of Northern Ireland from the common European market. 

After the departure of the United Kingdom from the EU (so-called Brexit), an agreement was reached due to the absence of a hard border between Northern Ireland (NI) and the Republic of Ireland, which regulated the movement of goods (including medicines). As a result, the rules set out by the EU Directive on the Falsification of Medicines (FMD, EU 2016/161) continue to apply in Northern Ireland. Tensions arising from the differing regulatory status of NI compared to the rest of the UK led to a revision of this agreement, which will take effect on January 1, 2025.From that date, the UK Medicines and Healthcare products Regulatory Agency (MHRA) will be responsible for the approval of all medicines placed on the market in Northern Ireland.

Impacts on the European market

It is not expected that the departure of Northern Ireland from the single market (the so-called NIXIT) and its disconnection from the European Medicines Verification System (EMVS) will cause problems for Czech pharmacies or wholesalers. However, several changes will take effect from January 1, 2025:

• All medicines sold in the territory of the United Kingdom (UK) must be labelled „UK only“ to prevent import of these medicines into the EU.
• The so-called "joint packs"e., packs intended for both the United Kingdom and EU countries, will no longer be possible to distribute in both markets, except for those that are already in circulation, have had their data uploaded to the EMVS, and were included in distribution before January 1, 2025.
• Medicines imported to the EU from the UK (just as medicines imported from other non-EU countries) must meet the FMD requirements.
• All national medicines verification systems will be adjusted to account for the upcoming new situations. (e.g. a new alert,)
• As of January 1, 2025, Marketing authorization holders/OBPs should not upload data related to medicinal packs to the UK market.

NIXIT: possible impacts

Counterfeits bearing false data from the legitimate UK packs could infiltrate the EU supply chain. The European Medicines Verification Organization (EMVO) and the National Medicines Verification Organization (CZMVO) therefore recommend that, after January 1, 2025, increased attention be given to the verification, decommissioning, and dispensing of medicines with British identifiers. If such a pack is scanned, the system will generate an alert based on the cause of their origin: 

• A70 alert - Market not available (the target market (UK) is disconnected from EMVS).
• A1 alert - Product code (PC) is unknown (the product master data do not exist in EMVS).
• A2 alert - Batch not found (the product master data exist in EMVS, but the batch is not uploaded).

A1 and A70 alerts do not belong to level 5 and according to the opinion of NCA (SÚKL) there is no need to close them. The alerts will be displayed to users of the Alert Management System (CZAMS) for informational purposes only. If all other conditions for dispensing the package are met, it can be dispensed to the public. A2 alerts will be investigated and closed in the standard way.

The latest information you can find on the websites https://www.czmvo.cz/en/ and /https://sukl.gov.cz/en/ where will be publishing updates from the end of November 2024 onwards. Further information and the frequently asked questions for MAH/OBP related to NIXIT are available on the EMVO website, www.emvo-medicines.eu.