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SecurMed UK

SecurMed UK is the UK Medicines Verification Organisation, a non-profit organisation set up to establish the UK Medicines Verification System for the UK. SecurMed UK are working with stakeholders across the medicines supply chain to enable the EU Falsified Medicines Directive to be implemented in the UK by the go-live date of 9th February 2019.

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Contacting SecurMed UK

SecurMed UK is the UK Medicines Verification Organisation, a not for profit organisation delivering the UK Medicines Verification System and EU Falsified Medicines Directive. For further information about the work of SecurMed UK please email info@securmed.org.uk  or call us on +44 20 3855 0656 (UK office hours are 08:00 to 18.00 Monday to Friday).


SecurMed UK announces IT Service Provider contract signature with Arvato Systems GmbH

SecurMed UK, the UK Medicines Verification Organisation is pleased to announce that on 09-Jul-2018 it has signed a contract with Arvato Systems GmbH as the IT Blueprint Service Provider for the United Kingdom. The UK is one of the largest and most complex markets for medicines supply within Europe and the appointment of Arvato Systems represents a significant milestone in the UK’s journey to meet its obligations under the Falsified Medicines Directive and associated Delegated Regulation. SecurMed UK and Arvato Systems look forward to working together to enable the UK medicines supply and healthcare sectors to successfully implement the UK Medicines Verification System by 09-Feb-2019. Please see announcement PDF for more details.

SecurMed contract signature completion

 

 

 

 

 

 


SecurMed Announces MAH Contracting and Fee Model

1. Manufacturers and Parallel Distributors – SecurMed announced in late-April the UK contracting and fee payment model for Marketing Authorisation Holders & Parallel Distributors (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 please email mah@securmed.org.uk .

In order to satisfy their obligations under the Delegated Regulation, from 09-Feb-2019, 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. Voluntary, early and prompt payment will reduce the Set-Up Fee by more than 35%, 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 important that manufacturers and parallel distributors take action to register with SecurMed UK at mah@securmed.org.uk .

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

Offer Ended.

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 MAH 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 15 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 no later than 15-Sep-2018, if the 2nd payment 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 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 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, BGMA or BAEPD (EAEPC) websites.

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, EMVO News & Events, the EMVO Knowledgebase and Q&A is available at www.emvo-medicines.eu

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 working NHS Digital to support NHS organisations in England for Hospital Pharmacy and Doctors, GPs and Health Centres. 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. Please contact NHS Digital at FMD@nhs.net.

6. IT Software Providers – SecurMed UK, through our IT Service Provider Arvato Systems, are providing an IT Solutions Developers Toolkit (SDK) to IT software providers and departments to enable them to create interface (web-services) connections to the UK MVS. The SDK contains a full set of technical documentation, a Sandbox test environment with test serial number creation, sample code snippets, test plans and reports, and a technical helpdesk service. To register for the SDK please visit https://sws-nmvs.eu.

PDF versions of the workshop presentations held in September 2017 can be downloaded here:

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

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 DHSC/MHRA at fmd.safetyfeatures@mhra.gov.uk for guidance.

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

IQE Test–
July 2018
PRD Production–
Sept 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