SecurMed UK FMD LATEST

SecurMed Announces MAH Contracting and Fee Model

  1. Manufacturers and Parallel Distributors – SecurMed has announced the the UK NMVO contracting and fee payment model.  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 please email mah@securmed.org.uk .

In order to satisfy their obligations under the Delegated Regulation, Marketing Authorisation Holders (MAHs) are required to register with SecurMed UK and to pay the applicable fees. This will initially be by way of payment of a Set-Up Fee per MAH as detailed in the table below.  Early and prompt payment will reduce the Set-Up Fee by more than 50%, and attract additional discounts from future Annual Operational Fees for the first 2 years from February 2019.

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. It is therefore crucially important that manufacturers and parallel distributors take prompt action.

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

01-Apr-2018 to 31-May-2018

52%

GBP £17,000

20% for first 2 years

01-Jun-2018 to 30-Sep-2018

38%

GBP £22,000

10% for first 2 years

01-Oct-2018 to 30-Nov-2018

23%

GBP £27,000

N/A

01-Dec-2018 to 31-Dec-2018

15%

GBP £30,000

N/A

01-Jan-2019 to 08-Feb-2019

6%

GBP £33,000

N/A

09-Feb-2019 or thereafter

N/A

GBP £35,000

N/A

Marketing Authorisation Holders and Parallel Distributors are defined as the legal entities holding one or more of:

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

Manufacturers and Parallel Distributors should now:

  • Download the Registration Form.
  • Complete a separate form for each MAH which will be active in the UK on 09 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 mah@securmed.org.uk no later than 30 April 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 no later than 18 May 2018, if maximum discount is to be achieved.
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, so a Company with multiple MAHs valid for the UK will be required to pay a Set-Up Fee and any other applicable fees for each MAH.

Key document links below giving details on the announcements:

  1. EMVO Onboarding for Manufacturers– all Marketing Authorisation Holders holding UK MAH, PLPI or EMA licenses are advised to onboard to the European Medicines Verification Organisation (EMVO) as soon as possible. Access to further information and the EMVO Onboarding portal is available here. To access the EMVO Knowledgebase and Q&A please click here

    EMVO announced on 09 February 2018 there is One Year to Go in the FMD implementation, please go to the EMVO News & Events page for more information.

  2. IT System Solution Providers – SecurMed UK and Arvato have held half day workshops to give details about the FMD implementation for the UK and the IT Solutions Developers Toolkit (SDK) to IT System Solution Providers serving Wholesalers and Dispensers (Hospitals, GP/Doctors, Clinics, Community Pharmacy).   To register for the SDK please visit https://sws-nmvs.eu

PDF versions of the workshop presentations can be downloaded here:
SecurMed UK - Introduction to FMD
Arvato IT SSP Workshop​​

A recording of the webcast workshop held in early November is now available on YouTube:

https://youtu.be/Lnu_ZN8_Kco

  1. Packaging & Labelling Changes and Medicines in FMD Scope– SecurMed UK is supervised by the Dept of Health and MHRA.  Where stakeholders are unclear on the proposed legislation, for example - packaging and labelling changes or whether types of medicine are in/ out of scope of the FMD implementation, please contact the MHRA for guidance.
     
  2. Other Medicines Dispensers– SecurMed UK is working with the Dept of Health/ MHRA to plan the FMD implementation for other medicines dispensers e.g. Prisons, Hospices, Ambulance Trusts and Care Homes. For further information on the impact of FMD implementation impact for other medicines dispensers, please contact the Dept of Health or MHRA.
     
  3. EU Commission Q&A on FMD– the EU Commission has published a link to their questions and answers page on the FMD implementation.

Dept of Health/ MHRA Mailbox and Newsletter Registration

The Department of Health and Medicines & Healthcare products Regulatory Agency (MHRA) have set up a dedicated mailbox to receive enquiries about the implementation of the safety features aspects of the Falsified Medicines Directive.  The mailbox is monitored daily and you can expect to receive a response within 5 working days.  Please contact us at FMD.safetyfeatures@mhra.gov.uk.

MHRA circulates a monthly FMD Safety Features Newsletter – its aim is to keep stakeholders posted on the latest developments with implementation.  If you don't currently receive a copy of the newsletter and would like to, please email the FMD mailbox above with the following – your name, your organisation (if applicable) and your title (if applicable).

​Outline SecurMed Implementation Plan

SecurMed UK is progressing delivery of the UK Medicines Verification System with Arvato and we are jointly communicating our target milestones up to the FMD go-live in 2019 as follows:

Phase

What will be delivered

When

System & Process     

  • System v1.1 (UK configured) live
  • Business and user management processes (v2.0) in place
  • Commence dispenser, wholesaler and IT provider connection to the system

July 2018

Service

  • System v1.2 live and fully validated
  • Business operational processes (v3.0) in place
  • SecurMed permanent office established and staffed
  • Operational readiness confirmed
  • NCA reporting and investigation processes in place and ready for use.
  • MAH, Dispenser, Wholesaler and IT Provider ramp-up in progress

December 2018

FMD Go-Live

  • FMD and Delegated Regulation come into force

09 February 2019

Operations

  • Service transition and handover to IT operations completed
  • Service management, SLAs and service performance in place
  • SecurMed office stabilisation completed
  • FMD ramp-up in progress

End March 2019