​​​​​​​​​​​​​​​​​Contacting SecurMed UK

SecurMed UK is the UK Medicines Verification Organisation, a not for profit organisation that will deliver the UK Medicines Verification System. It is not operated by the ABPI and our team is therefore unable to answer queries relating to the work of SecurMed UK. For further information about the work of SecurMed UK please email info@securmed.org.uk  or call them at +44 20 3855 0656 (UK office hours 08:00-18.00 Mon-Fri).

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

Payment deadline extended to Friday 22-Jun-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

The Annual 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 January each 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 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 8 Jun 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 15 Jun 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.

SecurMed UK Fee Waiver for micro MAHs

Following the recent announcements by SecurMed UK on 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 the fee levels 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 in the attached document: Micro MAH Fee Waiver.

Key document links below giving details on the announcements:

For further information, please visit the ABPI (this site), BGMA or BAEPD (EAEPC) websites.

  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. Community Pharmacy– SecurMed UK is engaging Community Pharmacy through the FMD Working Group set up by NPA, CCA and CP industry associations. The FMDSource web-site is a good reference for pharmacists interested in FMD. We are working with Community Pharmacy Scotland, Community Pharmacy Wales and Pharmacy Services Northern Ireland to coordinate the FMD implementation in the devolved countries.

  3. Wholesalers/ Distributors– SecurMed UK is supported by the Healthcare Distribution Association (HDA) to engage with and communicate with Wholesalers and Distributors. Please refer to the HDA website for further information about the FMD implementation.

  4. Hospital Pharmacy and Doctors/GPs– SecurMed UK is assisting NHS Digital to develop its implementation plans in England for Hospital Pharmacy and Doctors, GPs and Health Centre. Through NHS Digital SecurMed UK will be engaging with NHS Services/Informatics in Scotland, Wales, Northern Ireland, Channel Islands and Isle of Man to ensure effective roll​out in each of the devolved countries. For private sector care providers, SecurMed UK is in contact with the Association of Independent Healthcare Providers (AIHO).

  5. 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

  6. 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.

  7. 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.

  8. 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