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. 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.
SecurMed announced on 19th April 2018 the UK contracting and fee payment model for Manufacturers, Parallel Distributors and Marketing Authorisation Holders (MAHs). Please see attached links below to the letter from SecurMed UK to MAHs, a letter in support of SecurMed UK from the DHSC Minister and the MAH Registration form. For information on MAH contracting and fee payment model please email firstname.lastname@example.org .
The contracting and fee payment model provides a series of voluntary discount offers for the MAH Setup Fee (one-off payment) and the Annual MAH Operational Fee. MAHs may choose to take advantage of these voluntary discounts or wait until obliged to pay from February 2019.
Payment will initially be made of a Set-Up Fee per MAH as detailed in the table below. Voluntary, early and prompt payment will reduce this Set-Up Fee by more than 35%, and attract additional discounts from future Annual Operational Fees for the first 2 years from February 2019.
It is therefore important that manufacturers and parallel distributors take action to register with SecurMed UK at email@example.com
|Date of Receipt of MAH Setup Fee by SecurMed (dates inclusive)||Percentage (%) Discount on MAH Setup Fee||Set-Up Fee Payable||Discount on Annual MAH Operational Fees|
|1st April-2018 to 30th-June-2018
|1st June-2018 to 30th September 2018||38%||GBP £22,000||10% for first 2 years|
|1st October 2018 to 30th November 2018||23%||GBP £27,000||N/A|
|1st December 2018 to 31st December 2018||15%||GBP £30,000||N/A|
|1st January 2019 to 8th February 2019||6%||GBP £33,000||N/A|
|9th February 2019 or thereafter||N/A||GBP £35,000||N/A|
The Annual MAH Operational Fee is yet to be determined but is expected to be in the region of GBP £20-25,000 in 2019 and is expected to be invoiced in November of the preceding year for payment by 9 February of the relevant year. SecurMed UK acknowledges that this sum and payment schedule is an estimate and may change once the budget for 2019 and the number of MAHs to be invoiced in 2019 are confirmed.
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 take advantage of the discount offers above should:
- Download the Registration Form.
- Complete a separate form for each MAH which will be active in the UK on 9th February 2019, indicating your preferred payment schedule for each and provide contact details of an authorised signatory.
- Send the completed Registration Form(s) by email to: firstname.lastname@example.org no later than 15th September 2018.
Following receipt of your Registration Form(s), SecurMed UK will require the MAH to sign an Agreement and return the signed Agreement by email as soon as possible, and by no later than 15th September 2018, if the 2nd payment discount is to be actioned.
The MAH will then receive an invoice from SecurMed UK, to pay by the preferred payment deadline.
To avoid paying increased fees:
- Do not miss the deadline corresponding to the preferred payment schedule;
- All MAHs that miss their payment deadline will automatically be transferred to the following payment deadline. A supplementary invoice will be issued for the increase in fee resulting from any delayed payments;
- 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 recent announcements by SecurMed UK in late April/early May, of the MAH Setup Fee and Annual MAH Operational Fee structure for the UK FMD implementation, SecurMed UK has 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 introduce 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 below giving details on the announcements:
- 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 an onboard to EMVO as soon as possible to ensure they will be ready to supply pack information to the UK Medicines Verification System from 9th February 2019. The EMVO registration and onboarding process is lengthy and time-consuming and MAHs should commence registration at www.emvo-medicines.eu.