Marketing Authorisation Holders

Marketing Authorisation Holders (MAHs)

The Northern Ireland Protocol came into effect from 1^st 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.

Fees

• A set-up fee of GBP £1,000 is payable upon registration.
• The Annual MAH Operational Fee for 2021 is zero.
• The Micro Fee Waiver scheme is unchanged. Please see the explanation on how to apply here.

Register as an MAH

To register, MAHs need to:

• Download the MAH Registration Form
• Complete a separate form for each MAH that is active in NI, providing contact details of an authorised signatory
• Email the completed form(s) to the SecurMed MAH team.

Following receipt of your MAH Registration Form, SecurMed require each MAH to sign and return a SecurMed MAH Agreement via DocuSign.

More information

For further guidance, please also visit the MHRA, the ABPI, BGMA or BAEPD (EAEPC) websites.

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.