Marketing Authorisation Holders
In order to satisfy their obligations under the Delegated Regulation, from 9th February 2019, Manufacturers, Parallel Distributors and Marketing Authorisation Holders (MAHs) with POM Marketing Authorisations are obliged to fund SecurMed UK and the UK Medicines Verification System.
- A Set-Up Fee of GBP £35,000 is payable upon registration
- The Annual MAH Operational Fee for 2019 is GBP £20,000
- Payment should be made within 30 days on receipt of invoice
Without timely payment of fees, medicines will not be able to 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, including under the Delegated Regulation.
Marketing Authorisation Holders and Parallel Distributors are defined as the MAH legal entities holding one or more of:
- An MA applied for and granted by the EU’s Centralised Procedure (CP) by EMA
- A UK Marketing Authorisation (MA) applied for and issued by the MHRA
- An UK MA applied for and granted via the EU’s Decentralised Procedure (DCP) or Mutual Recognition Procedure
- A UK PLPI (parallel import licence) applied for and issued by the MHRA
- A Parallel Distribution Notification Letter issued by EMA.
MAHs wishing to register should:
- Download the Registration Form.
- Complete a separate form for each MAH which is active in the UK and provide contact details of an authorised signatory.
- Send the completed Registration Form(s) by email to: firstname.lastname@example.org .
Following receipt of your Registration Form(s), SecurMed UK require the MAH to sign an Agreement and return the signed Agreement by email as soon as possible.
The MAH will then receive an invoice from SecurMed UK for the Set Up fee and Annual Operational Fee.
PLEASE NOTE: fees are required to be paid by each MAH legal entity, so a Company with multiple MAH legal entities valid for the UK will be required to pay a Set-Up Fee and any other applicable fees for each MAH legal entity.
SecurMed UK Fee Waiver for micro MAHs
Following the announcements by SecurMed UK in late April/early May 2018, of the MAH Setup Fee and Annual MAH Operational Fee structure for the UK FMD implementation, SecurMed UK received feedback on fee levels, both directly from smaller companies and through their industry associations. After reviewing the feedback and consulting with UK competent authorities, the SecurMed UK Board of Directors has taken the decision to provide an annual fee waiver scheme, in respect of the MAH Setup Fee and Annual MAH Operational Fee, for those MAH or Parallel Distributor legal entities that can demonstrate that they are a micro MAH in the relevant year. Please find more details regarding micro MAH parameters in the attached document: Micro MAH Fee Waiver.
Key document links:
- Registration Form
- SecurMed letter to MAHs
- SecurMed MAH Agreement
- Guidance on completing MAH Agreement
- Letter from DHSC Minister to SecurMed Chair
Registering and Onboarding to EMVO
The registration with SecurMed UK and payment of fees does not complete the obligations on manufacturers, parallel distributors and marketing authorisation holders. Under the European FMD blueprint model all manufacturer pack data upload will be to the European Medicines Verification System (EMVS) operated by the European Medicines Verification Organisation (EMVO). SecurMed UK recommends all MAHs to register with and onboard to EMVO as soon as possible to ensure they can supply pack information to the UK Medicines Verification System. The EMVO registration and onboarding process is lengthy and time-consuming and MAHs should commence registration at www.emvo-medicines.eu.