NIXIT – Q&A for end users

Consequences of Northern Ireland leaving the EU Single Market for the Verification of Medicines for end users 

The most frequently asked questions and answers for end users regarding NIXIT can be found on the NOOL website in the section “Important information/Q&A”.

Due to the absence of a hard border between Northern Ireland and the Republic of Ireland, the rules governing the movement of goods in Northern Ireland were different from those in the United Kingdom (UK), including the market for medicines covered by the Falsified Medicines Directive (FMD 2011/62/EU, FMD) as in the European Union (Windsor Framework). However, tensions over the different regulatory status of Northern Ireland compared to the rest of the United Kingdom have led to an amendment that will enter into force on 1^st January 2025, according to which Northern Ireland will leave the EU Single Market (NIXIT), including the market for medicines.

Some of the changes may also have an impact on EU Member States from the perspective of the FMD, however, this is not expected to cause problems for end users (pharmacies and distributors) of the National Medicines Verification System (NMVS) in the Czech Republic.

All packaging placed on the UK market from 1 January 2025 will be marked as “UK only”. Packaging marked “UK only” placed on the UK market from 1 January 2025 should not contain a 2D code from the FMD perspective. Verification of such packaging will generate an alert in the NSOL system, which, however, does not prevent the dispensing of the packaging or other handling of it.

The obligation for end users in the Czech Republic (pharmacies and distributors) towards the FMD does not change. The end user must verify all packaging with a 2D code. After the disconnection of the UK systems, all UK packaging with 2D codes scanned in the Czech Republic will generate an alert, as the packaging data will no longer be available for verification in the Czech Medicines Verification System (CZMVS):

• Alert A70 – market not available, target market (UK) is disconnected from the European Medicines Authentication System (EMVS).
• Alert A1 – product code (PC) is unknown, master data for the medicinal product does not exist in the EMVS.

If other conditions preventing the release of the package are not violated, it can be released to the public.

 

We recommend that you follow the current information about NIXIT on the following links:

NOOL website: www.czmvo.cz

SÚKL website: www.sukl.gov.cz