PowerPoint Presentation - GS1...Title PowerPoint Presentation Author GS1 Created Date 3/30/2017 7:44:19 PM

Geraldine Lissalde-Bonnet, GS1 Global Office

GS1 Ireland Healthcare User Group (HUG)

Information Day

Overview on EU FMD regulation and unique identification requirements

28th March 2017

Overview on EU FMD and unique

identification requirements

GS1 Ireland HUG Information Day

28 March 2017, Dublin - Ireland

Géraldine Lissalde-Bonnet, GS1 Global Office

© Copyright GS1 AISBL, 2012-2017. All Rights Reserved.

Counterfeit drugs: a global challenge for healthcare

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Counterfeits make up more than 10% of the global medicines market. Approximately 1% of counterfeit drugs have penetrated the supply chain in developed countries.

European Commission: http://ec.europa.eu/internal_market/indprop/docs/conf2008/wilfried_roge_en.pdf

Worldwide sales of counterfeit drugs is in excess of $75 billion annually.

World Health Organisation: http://www.who.int/medicines/services/counterfeit/overview/en/

More than 50% of medication and pharmaceuticals purchased online are falsified.

World Health Organisation: http://www.who.int/medicines/services/counterfeit/overview/en/


Around the world…

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Traceability/Visibility

• Very high on the mind of regulatory bodies to address

public health issues

• Different ways and models to implement

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Different approaches

Traceability


In the EU

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Why the EU FMD?

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EU Falsified Medicine Directive 2011/62/EU (FMD)http://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2011_62/dir_2011_62_en.pdf

EU Commission Delegated Regulation 2016/161https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2016_161/reg_2016_161_en.pdf

Prevent the entry into the legal supply of falsified medicinal products by requiring 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 allowing their

identification and authentication.


EU FMD at a glance

1. Safety Features

• Verification - Repository system

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2. Active substance quality

3. Online pharmacies

• A unique identifier (UI), a unique sequence carried by a 2D barcode allowing the identification and authentication of the individual pack on which it is printed 2;

• An anti-tampering device (ATD) allowing the verification of whether the packaging of the medicinal product has been tampered or not (not relevant for GS1 but regulated under CEN).

• End-to-end verification system of authenticity and integrity of the

safety features placed on the packaging of a medicinal product at

the time the medicinal product is supplied to the public.

• Risk-based verifications by wholesale distributors


Scope of the EU FMD

• Medicinal products for human use …

… subject to prescription, unless included in Annex I

… not subject to prescription which are included in Annex II

… to which Member States have extended the scope of application of the UI or the ATD

• Products already on the market may be distributed and supplied to the public in that Member State until their expiry date

• New or ongoing marketing authorisation products have to be compliant

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Timeline for implementation

• Applies as of 9 February 2019

• Belgium, Greece and Italy have the option of deferring the

application of the rules by an additional period of up to 6

years (i.e. 2025)

• Belgium and Greece announced that they are planning to

align with the 2019 timeline

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The EU Unique Identifier

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Source: EU Commission Stakeholder Meeting, February 2016


GS1 linear and 2D barcode

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Item identifier Expiry date

Batch number

Serial number(21)123


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01 GTIN (Global Trade Item Number) – 14 digit numeric

10 Batch / Lot – up to 20 characters -alphanumeric

17 Expiry Date – format is YYMMDD – so for today 170324

21 Serial Number – up to 20 characters -alphanumeric

GS1 Application Identifiers…

Sequence: GTIN first - then recommend to have fixed length - followed by variable length


Keep yourself informed

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• Bi-weekly conference calls of specific Public Policy group

• Contribute and watch the EU FMD Coding Tracker

• Important information to make changes now

• Multi-country packs?


Verification - Repository system:European Stakeholder Model (ESM)

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Source ESM presentations

A pan-European end-to-end system enabling medicines to be verified at point of dispensing.https://www.emvo-medicines.eu/about-us/european-medicines-verification-organisation/

https://www.emvo-medicines.eu/about-us/european-medicines-verification-organisation/


Need to be active at the national level

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The time to act is now

© GS1 2017

31st Global GS1 Healthcare Conference4 to 6 April 2017, Berlin, Germany

• Traceability, Unique Device Identification (UDI) and global

regulatory developments

• Use cases and implementations from manufacturers, wholesalers

and hospitals – what are the experiences, the benefits

• Patient safety and quality of care – how to improve those

• ThinkTank for regulatory bodies

• Followed by side visitsParticipation free for regulatory bodies and hospitals


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Questions ?

© GS1 2017

Geraldine Lissalde Bonnet

Director Public Policy Healthcare

GS1 Global Office, Brussels

E [email protected]

W www.gs1.org/healthcare

Contact Details

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PowerPoint Presentation - GS1...Title PowerPoint Presentation Author GS1 Created Date 3/30/2017 7:44:19 PM