Marketing Authorisation Holders

Marketing Authorisation Holders (MAHs)

To satisfy their obligations under the Delegated Regulation (DR), Manufacturers, Parallel Distributors and Marketing Authorisation Holders (MAHs) with POM Marketing Authorisations (MAs) are obliged to fund SecurMed and the UK Medicines Verification System (UK MVS).

What qualifies as an MAH?

MAHs are defined as the MAH legal entities holding one or more of:

1. An MA applied for and granted by the EU’s Centralised Procedure (CP) by EMA
2. An UK MA applied for and granted via the EU’s Decentralised Procedure (DCP) or Mutual Recognition Procedure
3. A UK MA applied for and issued by the MHRA
4. A UK parallel import licence (PLPI) applied for and issued by the MHRA
5. A parallel distribution notification letter issued by EMA.

Fees

• A set-up fee of GBP £35,000 is payable upon registration
• The Annual MAH Operational Fee for 2020 is GBP £20,000
• Payment should be made within 30 days on receipt of invoice.

Without timely payment of fees, medicines will not be verified or authenticated at the time of supply to patients in the UK, and MAHs may therefore be in breach of their legal obligations.

‘Micro MAHs’ may be eligible for a SecurMed Fee Waiver. Following feedback from smaller companies and their industry associations, SecurMed decided to provide an annual Fee Waiver for MAH or Parallel Distributor legal entities that can demonstrate that they are a ‘micro MAH’ in the relevant year.

For more information, please see our SecurMed Fee Waiver guidance.

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 the UK, providing contact details of an authorised signatory
• Email the completed form(s) to the SecurMed MAH team.

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.

Each MAH will then receive an invoice from SecurMed for the set-up fee and Annual Operational Fee.

PLEASE NOTE: An organisation or company with multiple MAH legal entities will be required to pay a set-up fee and any other applicable fees for each one.

More information

For further guidance, please see the SecurMed Letter to MAHs, the Letter from DHSC Minister to SecurMed Chair, or visit the ABPI, BGMA or BAEPD (EAEPC) websites.

The United Kingdom formally departed from the European Union on 31st January 2020, entering into a Transition Period lasting until 31st December 2020. As from 1st January 2021, unless a negotiated UK/EU trade agreement outcome changes the current position, FMD legislation will only apply in the UK in respect of Northern Ireland. 

The SecurMed UK Board has decided not to charge an Annual MAH Operational Fee for 2021.   The MAH Setup Fee level remains under review by SecurMed Board until there is further clarity on the outcome of the UK/EU negotiations or the UK Government has published its direction and guidance on the application of FMD in Great Britain and Northern Ireland from 1st January 2021 onwards.

Register with EMVO

Registering with and paying fees to SecurMed does not complete the obligations on MAHs, Parallel Distributors and Manufacturers.

Under the European FMD blueprint model, all Manufacturer pack data should be uploaded to the European Medicines Verification System (EMVS), operated by the European Medicines Verification Organisation (EMVO).

SecurMed recommends that all MAHs register with and onboard to EMVO as soon as possible, to ensure they can supply pack information to the UK MVS.

To register, please visit the EMVO website.