Marketing Authorisation Holders

Marketing Authorisation Holders (MAHs)

The Northern Ireland Protocol came into effect from 1^st January 2021 and the Falsified Medicines Directive continues to apply in Northern Ireland.

MAHs are obliged to contract with and pay fees to SecurMed if their Marketing Authorisation is valid for Northern Ireland.

The fee levels for Northern Ireland are set out below:

• A set-up fee of GBP £1,000 is payable upon registration.
• The Annual MAH Operational Fee is £2,500.

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 and send this by email to [email protected]

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.