UK consultation on the User Requirement Specifications for the UK Medicines Verification System

Closed 13 Jul 2016

Opened 15 Jun 2016

Overview

The Falsified Medicines Directive and associated Delegated Regulation was introduced by the EU in October 2015. It introduces measures which aim to prevent the entry of falsified medicines into the legal pharmaceutical supply chain.

It requires the placing of safety features consisting of a unique identifier and an anti-tampering device on the packaging of certain medicinal products for human use, for the purposes of enabling their identification and authentication.

This Regulation also requires pharmaceutical manufacturers and supply chain stakeholders to establish a pan-European system, ensuring the identification and the authentication of medicinal products is assured by the end-to-end verification of all medicinal products bearing the safety features.

Over the last 2 years, the organisations representing the pharmaceutical manufacturers and supply chain stakeholders required to implement these requirements have proactively engaged with their own members, suppliers to those members, the NHS and the Government. We have done this through the establishment of our own Forum, which has overseen the development of our proposals for implementation of the FMD, and which has

  • invited other stakeholders to attend our meetings
  • coordinated with the MHRA awareness raising campaigns using their databases
  • attended supply chain and other conferences
  • facilitated meetings between IT suppliers to the supply chain and the potential system providers for the UK implementation
  • So there has been and continues to be an ongoing informal consultation process including stakeholder events and engagement across all supply chain actors and constituencies.

 

This more formal consultation specifically seeks your views on the proposed User Requirement Specifications (URS) for the UK Medicines Verification System (UKMVS) as required by the Delegated Regulation (EU) 2016/161 of 2 October 2015.

It also seeks your views on a Memorandum of Understanding (MoU) developed and agreed between the UK pharmaceutical supply chain stakeholders, who will take on the responsibility for its management under the supervision of the UK competent authority.

We welcome you and your organisation’s feedback and encourage you to share this consultation with interested colleagues.

For further or future engagement with the development of the UKMVS you are encouraged to proactively reach out to the most relevant UK principal representative stakeholder associations below, or your own professional organisation:

  • ABPI (Branded Manufacturers)
  • BGMA (Generic Manufacturers)
  • BAEPD (Parallel Distributors)
  • NPA and CCA (Dispensing Entities)
  • HDA (Wholesalers) 

 

Background Information

The EU Falsified Medicines Directive

As the EU Directive 2011/62/EU - also called the Falsified Medicines Directive (FMD) - requires that prescription-only medicine packs will include safety features (i.e. a unique identifier or serial number placed on each pack together with tamper evident packaging), pharmaceutical manufacturers will be required to invest time and funds to modify machinery in manufacturing and/or packing sites.

However, the FMD and its associated Delegated Regulation not only require manufacturers to serialise medicine packs, they also require the establishment of national repositories and associated IT systems, which allows the verification and authentication of these packs.

The majority of costs associated with developing and managing the repositories system which will allow pan- European verification of medicines will also be borne by the manufacturing authorization holders (i.e. manufacturers & parallel distributor) of the medicines bearing the safety features.

The Directive and Delegated Regulation also imposes obligations and expectations in the use of the verification system on both;

  • “Persons authorized or entitled to supply medicinal products to the public”
  • “Wholesalers”.

 

Taken as a whole, the establishment of national repositories, associated IT systems and changes in work flows will place time and financial burdens on all actors in the supply chain.

 

 

The European Medicines Verification System

To this end, European stakeholders EAEPC (parallel distributors), EFPIA and EGA (now “Medicines for Europe”)  (manufacturers) – collectively the ‘payers’, and PGEU (community pharmacists), GIRP (wholesalers) – have collaborated to agree and promote the development of an appropriate solution to the requirements of the Directive - the European Medicines Verification System (EMVS). 

This solution comprises a single European central ‘hub’, which provides a single portal for entry of manufacturer serialisation codes, connected to a series of national/regional information databases or repositories. These National repositories will serve as the verification platforms that pharmacies, wholesalers or other authorised parties can use to check a pack’s authenticity, before being ‘decommissioned’ from the system (decommissioned) on being supplied to the patient. 

The European stakeholders have established a not-for profit legal entity, the European Medicines Verification Organisation (EMVO) to deliver the EMVS by establishing a central European Hub, and offering support to National Stakeholders in the establishment of appropriate National Systems.


A UK Medicines Verification System

In the UK, the principal representative stakeholder associations namely ABPI (Branded Manufacturers), BGMA (Generic Manufacturers), BAEPD (Parallel Distributors), NPA and CCA (Dispensing Entities) and HDA (Wholesalers)) have created an alliance (UK ESM FMD Partners) to drive an UK Stakeholder approach which mirrors that of the European model.

The ultimate aim is to deliver a UK Medicines Verification System (UKMVS), aligned and intrinsic to the vision and the operational functionality of the EMVS. Again, following the European model the UKMVS will be set-up and managed by a non-profit legal entity – the UK Medicines Verification Organisation (UKMVO) under the supervision of the UK Competent Authority (MHRA and DoH).

In the meantime, the UK ESM FMD Partners have agreed a Framework Memorandum of Understanding (MoU) which describes the principles, conditions and governance arrangements by which the UKMVO is expected to operate. This Framework MoU can be found on each Partner website.
 

Why We Are Consulting

The UK principle representative stakeholder associations, namely: 

  • ABPI (Branded Manufacturers),
  • BGMA (Generic Manufacturers),
  • BAEPD (Parallel Distributors),
  • NPA and CCA (Dispensing Entities) and
  • HDA (Wholesalers)

 

are launching this 4-week consultation on the proposed User Requirement Specifications (URS) for the UK Medicines Verification System (UKMVS).

The consultation will run for a period of 4 weeks from 15 June 2016 until 13 July 2016, and is open to all stakeholders or stakeholder associations.

In particular, and in-line with the requirements of the delegated Regulation, we would like to hear from “wholesalers, persons authorised or entitled to supply medicinal products to the public and relevant national competent authorities”.

We are asking you to review the proposed URS document and in particular highlight;

  • Any discrepancies with the requirements of the Delegated Regulation (EU) 2016/161
  • Any concerns regarding the overall architecture of the EMVS and in particular the key tasks of the National System
  • Any disagreement with the Governing Principles
  • Any disagreement with the Design and Implementation Principles
  • Any critical gaps in the major functions or additional requirements as outlined
  • Any additional user requirements, specific to the needs of a UK verification system
  • Any priority ‘use cases’ not currently listed


You can respond using the online survey below, or

Email: you can email your response to: esm-fmd-consultations@abpi.org.uk

Post: you can send your response to:

Paul Melhuish

BGMA/BBA

65 Gresham Street

London

EC2V 7NQ

Areas

  • All Areas

Audiences

  • Medicines manufacturers
  • Medicines parallel distributors
  • Medicines wholesalers
  • Dispensing entities and pharmacists
  • Clinical Commissioning Groups and GPs
  • Healthcare institutions
  • Health bodies and agencies
  • Healthcare providers
  • Patient organisations

Interests

  • Medicines manufacture
  • Medicines supply
  • Pharmaceutical supply chain