EU Falsified Medicines

Directive – developments

and implementations across

Europe

June 2016

Joan Cahill

Pfizer

EFPIA Supply Chain Workgroup – Coding & Serialisation

Disclaimer

This presentation does not necessarily reflect

the views of Pfizer Inc.

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Content

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Medicines verification in the EU: Overview

European Stakeholder Model → EMVO

Progress to date

EU Falsified Medicines Directive

Safety Features

Authenticity

Pack Identity

Tamper evidence

Good distribution

Wholesalers & Brokers

GDP

Active substances

GMPs for excipients

Internet Sales

Community logo

Feb 9, 2019 2013-Q1 July 2, 2013 2015

Registration API

activities

Jan 2, 2013

Implementation of serialization, verification

system and tamper evident features

Objective Protection of patients from counterfeited

medicines in the legal distribution chain

Content Pan-European system to verify the authenticity

of medicinal products

Cost Paid by Marketing Authorization Holders

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2011

Feb 9 2019CompleteImplementation(BE/EL/IT Feb 9 2025)

Feb 9 2016Publication of

Delegated Regulation(EU) 2016/161

July 2011Publication of FMD

(2011/62/EU)

36 Mon.

20192015

Delegated Regulation mandates medicines

verification

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Serialization by manufacturer

+

Verification at point of dispense

Safety Features:

Unique Identifier (PC, Lot, Exp, SN)

+

Anti-Tamper Device (ATD)

System set up and governed by

stakeholders under supervision

of competent authorities

Product #: 09876543210982

Batch: A1C2E3G4I5

Expiry: 140531

S/N: 12345AZRQF1234567890

Pan-European System

National verification Systems (NMVS) connected by the

European Hub

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National

System

Pharmacy Wholesaler

Pharmaceutical

ManufacturerParallel

Distributor

National

System

National

System

National

System

National

System

National

System

European

Hub

Content

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Medicines verification in the EU: Overview

European Stakeholder Model → EMVO

Progress to date

Multiple stakeholders are involved

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EU SolutionManufacturer

Parallel distributors

Pharmacy

Distributor/

Wholesaler

Stakeholders work together to deliver a solution across Europe which delivers

the patient safety objectives

European Stakeholder Model

Aligned to a Common vision to protect patients

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Protect patients

Secure the legitimate supply chain

Be proactive as market partners

Formed a stakeholder-governed model that is

Functioning

Harmonised

Cost-effective

Inter-operable

Established the European Medicines

Verification Organization (EMVO)

Andreas Walter, EMVO, General Manager

andreas.walter@emvo-medicines.eu

European Medicines Verification Organization (EMVO)

System management and governance by not-for-profit organisation

under supervision of relevant competent authority

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Governance Structure

Allows for Effective Management of Verification System

EMVO and National Organisations (NMVOs) cooperate on the basis of service level agreements

NATIONAL LEVEL• National Medicines Verification

Organisations (NMVO), e.g. in Germany: securPharm e.V.

• Governed by national stakeholders with supervision by competent authorities

EU LEVEL• Governance model includes

EU industry associations with supervision by EC

• Oversees EU Hub Blueprint template Service providers Service agreements

Basic Principles

Basic concept: “Point-of-Dispense Verification”

All verification activities are performed in national systems of the EU memberstates

Interoperability between the different national systems through European Hub

Data owned by party that generates it

Data of other parties cannot be accessed except:

For verification purposes

If specifically agreed between partners

Supervision by relevant competent authorities

For reimbursement / pharmacovigilance purposes

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Support for the GS1 Standards

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http://www.efpia.eu/uploads/Modules/Documents/efpia-gs1-shared-vision-090312_2.pdf

http://www.ifpma.org/wp-content/uploads/2016/03/Joint-Industry-Position-Paper-on-Serialization-and-Product-Verification-.pdf

Concept: Point of Dispense Verification

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Pan European ArchitectureDesigned for interoperability and efficiency

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German National

System

PharmacyWholesaler

Pharmaceutical

Manufacturer

Parallel

Distributor

National

System

National

System

National

System

National

System

National

System

European

Hub

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The National Blueprint System Approach

Interoperable, cost efficient, reduced complexity

National

System

PharmacyWholesaler

Pharmaceutical

Manufacturer

Parallel

Distributor

National Blueprint

System

National

System

National Blueprint

System

National Blueprint

System

National

System

European

Hub

Content

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Medicines verification in the EU: Overview

European Stakeholder Model → EMVO

Progress to date

EU Hub Progress to Date

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EU Hub built and operational

Companies testing data uploads to EU Hub

EU Hub connected to German securPharm system

Companies preparing to load data to EU Hub intended for

the German securPharm system

NMVO/NMVS Current Status

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NMVS Blueprint Template solution providers selected and frame contracts negotiated

Majority of countries prefer adopting the Blueprint Template

Working with national associations to form NMVOs and prepare to deploy national systems

15

14

22

0

31

11

810

16

24

6

27

132

8

4

3

26

19

17

8

12

30

9

32

2

5

29

22

7

11

5

23

2

1

Blueprint candidate

Small Country Blueprint

Blueprint open

Standalone system

No Information

Non EU Countries

EMVO Observations

Program Progress

Positive development in a few Countries

Most Countries aim for Supplier Contract in 2016

To be improved

Too many Countries not Aligned yet

Stakeholder Alignment in MOU and Statutes not complete in

several Countries (e.g. Pharmacies and Wholesalers not

integrated in NMVO set up)

Technical Work Stream not yet started in too many Countries

No further progress in favour of Blueprint

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NMVOs forming now

NMVOs selecting Blueprint vendor in 2016

Deploying 32 NMVS’s in advance of February 9, 2019

deadline

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Next steps…

EFPIA Brussels Office

Leopold Plaza Building

Rue du Trône 108

B-1050 Brussels - Belgium

Tel: +32 (0)2 626 25 55

www.efpia.eu

EFPIA Supply Chain Workgroup – Coding & Serialisation