​​​​​​​​​​​​​​​​​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.


On 18 July 2017, SecurMed UK announced​ it has entered into a Letter of Intent with Arvato Systems GmbH as the Blueprint Service Provider for the UK. SecurMed UK has commenced work with Arvato Systems to plan the implementation of the UK Medicines Verification System.

SecurMed UK are working with stakeholders from across the medicines supply chain to ensure a fully FMD compliant service, and end to end Medicines Verification System, is implemented for the UK. SecurMed is working closely with its' constituency industry associations and EMVO to ensure preparedness:

  1. Manufacturers and Parallel Distributors– SecurMed UK is currently finalising UK engagement and financial arrangements for manufacturers and marketing authorisation holders in the UK market. For further information, please visit the ABPI (this site), BGMA or BAEPD (EAEPC) websites for more information.
      
  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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

  7. 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.

  8. 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.

  9. 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         

  • System v1.0 (vanilla) live and connected to EMVS.
  • Foundation SecurMed business processes (v1.0) in place
  • Commence Marketing Authorisation Holder (MAH) data download into SecurMed System.

End March 2018

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

End June 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

 

Pre-registration of UK Marketing Authorisation Holders

In early Q1 2018 SecurMed UK will publish the SecurMed Funding Model setting out the fee structure and contracting model for Marketing Authorisation Holders in the UK.   During Q1 SecurMed UK will commence the UK MAH contracting process in readiness for the System V1.0 Live release at end of March.  

SecurMed UK requests all UK Marketing Authorisation Holders for prescription medicines within FMD scope to pre-register your MAH details with use by sending an email to info@securmed.org.uk with the following information:

  1. Your company and address details
  2. Your Marketing Authorisation Holdings (both MHRA and EMA) applicable to UK
  3. The name and contact details of the Responsible Person for all of your MAHs

SecurMed UK needs to know all the company / business entity details of all business entities under each organisation holding MAHs, for some companies this maybe multiple business entity names.   SecurMed UK request that companies identify where possible a single Responsible Person for all MAHs related to your company/ business.   SecurMed UK do not need to know the names of the individual medicines/ medicaments.

Marketing Authorisation Holders for the UK are defined as:

MHRA

  • An UK Marketing Authorisation (MA) applied for and issued by the MHRA
  • UK PLPI (parallel import licence) applied for and issued by the MHRA

For the MA / PLPI holdings the first 5 digits of your product marketing license number provide the Marketing Authorisation information required.  

European Medicines Agency (EMA)

  • An UK MA applied for and granted via the EU’s Decentralised Procedure (DCP)
  • An MA applied for and granted by the EU’s Centralised Procedure (CP)

EMA licenses apply to all EU member states so companies need to consider if you hold both MHRA and EMA MAHs applying to the UK.

For further information or to contact SecurMed UK please email info@securmed.org.uk