30th November 2020

As you will know, although the GB countries of England, Scotland and Wales are no longer bound by the Falsified Medicines Directive from midnight on 31^st December 2020, it will continue to apply in Northern Ireland for at least four years.

What this means is that NI pharmacies will remain connected to the UK National Medicines Verification System which is run by SecurMed UK.

McLernons have had continued discussions with SecurMed UK to establish what this will mean for our customers.

You need to continue to verify and decommission any packs with the FMD safety features (such as unique identifiers and anti-tamper devices).

SecurMed will have an enhanced presence in Northern Ireland and will continue to provide end user registration and support.

From midnight on New Year’s Eve, Securmed will start to disconnect all GB end-users, and it is essential that you make sure that you check with your FMD software provider to ensure that they will continue to provide a service from 1^st January 2021. If you have purchased your FMD software from McLernons then please rest assured  that your service will continue.

It is important to remember that your security certificate will expire two years after initial download, so if you were an early adopter please check with your FMD provider that your certificate is still valid. It is possible that your initial log-in credentials may have expired, including passwords, etc, so it is important to ensure that everything is up-to-date and in place.

Complying with FMD is a legal requirement, and the inspection authorities have the ability to check to see if community pharmacies are scanning and decommissioning any packs with the FMD safety features.

In summary

• FMD still applies in NI from 1^st January 2021
• You must check if your FMD provider will continue to provide a service to NI customers
• Check with your provider that your security certificate is up-to-date
• Check with your provider that your log-in credentials are still active
• Audits of compliance can be made by the regulatory authorities

Some helpful sources of information are

https://www.npa.co.uk/news-and-events/news-item/future-of-the-safety-features-measures-under-fmd-in-great-britain-and-northern-ireland/

https://securmed.org.uk/emvo-news/emvos-communication-regarding-the-impact-of-brexit-and-the-northern-ireland-protocol-in-the-emvs/