FMD

Introduction

The Falsified Medicines Directive (FMD) and associated Delegated Regulation (DR) impose regulatory obligations on all Pharmaceutical Manufacturers, Parallel Distributors, Marketing Authorisation Holders, Community Pharmacies, Hospital Pharmacies, GPs, Health Centres and Pharmaceutical Wholesalers.

The legislation comes into force on 9th February 2019 by which time end users must be ready to implement FMD.

The scope of FMD covers all prescription only medicines (POMs) as set out in regulation 2016/161/EU. Exceptions to the regulation for some medicines are listed in Annex I and II of the Delegated Regulation.

Manufacturers, Parallel Distributors and Marketing Authorisation Holders are required to make changes to their POM packaging and labelling to add anti-tamper proof devices, additional human readable information and a 2D machine readable matrix to enable scanning of medicines.

In addition, they are required to upload the human readable information to a Europe-wide database for verification and decommissioning of medicine packs by end users.

Community Pharmacies, Hospital Pharmacies, GPs, Health Centres and Pharmaceutical Wholesalers are required to make changes to their business process and IT systems to enable them to verify and authenticate medicines as they travel through the supply chain to dispense to patients.

IT systems are required to create a connection to the UK Medicines Verification System (UKMVS).

The UK Medicines Verification System

SecurMed is the UK national medicines verification organisation that will enable your pharmacy to scan, check and decommission medicines at the time of supply to the patient.

The organisation is 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.

All End Users affected by FMD regulatory obligations are required to register with the UKMVS before FMD comes into effect on 9th February 2019. This registration process is widely referred to as on-boarding.

A step by step guide to FMD on-boarding is available on this website.

Summary

The following steps are required for the implementation of FMD by 9th February 2019:

  1. Purchase of an FMD-aligned system for scanning the new 2D Data Matrix, also known as the unique identifier (UI) code on medicines.
  2. Creation of User Account with SecurMed in order to proceed with registration (on-boarding)
  3. Registration with SecurMed (on-boarding) either Single or Bulk Registration
  4. Receipt of login details from SecurMed (approx. 15 days after registration)
  5. Receipt of link for Software Certificate from SecurMed (approx. 15 days after registration)
  6. Activation of the Software Certificate with your chosen scanning system,

Terminology

  • FMD – Falsified Medicines Directive
  • NMVS – National Medicines Verification Service
  • EMVS – European Medicines Verification Service
  • UKMVS – United Kingdom Medicines Verification Service
  • Requestor– The person who can Register End User Locations.
  • End User Location– The Name of Legal Entity and Address Location from which medicines are dispensed.
  • End User Location Contact– The person authorised to dispense medicines from that location and receive the logon access credentials.
  • End User Location Function– The principle function of the dispensing location (e.g. Pharmacy, Dispensing Surgery, Wholesaler).
  • Software Supplier– The vendor of the software you will use to access the UKMVS.
  • User Name and Password– The login credentials required to access the UKMVS.
  • Software Certificate– A small piece of code that works in unison with the User Name and Password to verify the End User Location to the UKMVS. Depending on your IT setup this may be installed on all terminals or computers within the End User Location or may be installed on a central server through which all dispensing transactions are routed from the terminals or computers in the location.
  • Single Registration– Registration of a Single End User Location for a single Function. An End User Location that has more than a single function will require a Single Registration for each function at the same location.
  • Bulk Registrations– Registration of multiple End User Locations within the same Parent Company or Group at the same time.

The Registration Process

Registration –widely referred to as on-boarding- is the process to ensure pharmacy locations are connected to the UK Medicines Verification System for FMD.

The SecurMed on-boarding website https://www.securmed.org.uk/register/end-user-registration/ is open and end users are advised to register as soon as possible.

If an End User Location performs more than one function, a separate registration must be completed for each business activity e.g. Community Pharmacy with a Wholesaler Licence, the business must be registered as two individual End User Locations.

Registration is the responsibility of the Pharmacy Contractor (or other end user) and cannot be completed without the following information about the FMD solution being used:

  • Name of the legal body and address for the End User Location
  • End User Location Function(s)
  • Registration body for the Location and Registration ID
  • Name, Email and Business Phone for the End User Location Contact
  • Software Supplier Name
  • Software Name
  • Software Version