Marketing Authorisation Holders (MAHs)
The Northern Ireland Protocol came into effect from 1st January 2021 and will result in changes to regulations regarding medicines in relation to importation requirements and compliance with Falsified Medicines Directive.
There will be a twelve-month phased in approach of these regulations. This is to ensure there is no immediate impact on the supply of medicines following the transition period.
MAHs with new POM Marketing Authorisations intending to supply to Northern Ireland should register with SecurMed by the end of 2021.
Register as an MAH
To register, MAHs need to:
Following receipt of your MAH Registration Form(s), SecurMed require each MAH to sign and return a SecurMed MAH Agreement via email. For more information, please see our Guidance for SecurMed MAH agreement.
Register with EMVO
Registering with and paying fees to SecurMed does not complete the obligations on MAHs, Parallel Distributors and Manufacturers.
All Manufacturer pack data should be uploaded to the European Medicines Verification System (EMVS), operated by the European Medicines Verification Organisation (EMVO).
To register, please visit the EMVO website.