Marketing Authorisation Holders (MAHs)
The Northern Ireland Protocol came into effect from 1st January 2021 and the Falsified Medicines Directive continues to apply in Northern Ireland.
We are now operating with NMVS Alerts AMS. If you wish to manage your alerts, please email us on ams@securmed. org. uk and we will send you a link to register and enable you to log into the system.
Ready to log in to the UKNI MVS? Please follow the links to instructions below.
Please find below links to public sites which provide useful information for the implementation of the Falsified Medicines Directive. MHRA have provided guidance for the implementation and compliance of the Safety Features Regulation: Implementing the Falsified Medicines Directive: Safety Features.
Registering with SecurMed for Access to the UKNI MVS
New Registration
Registration is required of all organisations and companies that handle or dispense prescription medicine, located in Northern Ireland, including (but not limited to):
Community Pharmacies
Hospital Pharmacies
GP Practices and Health Centres
Dispensing Doctors
Inpatient/Outpatient Clinics
Wholesalers
Multiple Functions
If your End User…
What is an AMPP code?
Actual Medicinal Product Pack (AMPP) codes uniquely identify a packaged product. An AMPP is the packaged product which is supplied for direct patient use.
1. Onboard to the European Medicines Verification Organisation(EMVO)
All MAHs must onboard to EMVO to be able to upload pack information to the UKNI MVS. EMVO will perform the required assessments, contract the MAH and process the payment before granting access to the EMVS.
For those organisations who do not have an IT software provider, or who seek to find companies providing solutions, SecurMed has published the following list of providers.
SituationUKNI Medicines Verification users may receive system generated emails advising their certificate will expire soon and requesting them to download a new certificate.
For details of the scope of the regulation please check: FMD Delegated Regulation 2016_161
Where stakeholders are unclear on the legislation, for example whether types of medicine are in/out of scope, please contact DHSC/MHRA at fmd. safetyfeatures@mhra. gov. uk.
The Scanner Check Packs are designed to help users of the UKNI MVS to verify their Falsified Medicine Directive (FMD) software and scanner set up and avoid false-positive errors.
We recommend you contact your software supplier in the first instance, as they may have a record of your existing password, or provide the functionality to reset it. You can use the reset password function found in the UKNI MVS GUI.
We are now operating with NMVS Alerts AMS. If you wish to manage your alerts, please email us on ams@securmed. org. uk and we will send you a link to register and enable you to log into the system.
The UK is still committed to meeting the requirements of EU FMD safety features Delegated Regulation in Northern Ireland, and the MHRA expect all stakeholders in the supply chain to…
The table below details the Level 5 exceptions (Alerts) generated by the UKNI MVS.
Please make sure you have completed STEP 1 - Download Certificate before following STEP 2. We have created videos to explain the processes for you. By clicking on the Play Button below, you can watch and listen before you begin.
