GS1 Ireland Healthcare User Group (HUG) Information Day
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1 GS1 Ireland Healthcare User Group (HUG) Information Day Overview on EU FMD regulation and unique identification requirements Geraldine Lissalde-Bonnet, GS1 Global Office 28 th March 2017
2 Overview on EU FMD and unique identification requirements GS1 Ireland HUG Information Day Géraldine Lissalde-Bonnet, GS1 Global Office 28 March 2017, Dublin - Ireland
3 Counterfeit drugs: a global challenge for healthcare Worldwide sales of counterfeit drugs is in excess of $75 billion annually. World Health Organisation: feit/overview/en/ 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: f2008/wilfried_roge_en.pdf More than 50% of medication and pharmaceuticals purchased online are falsified. World Health Organisation: rvices/counterfeit/overview/en/ 3
4 Around the world 4
5 Traceability/Visibility Very high on the mind of regulatory bodies to address public health issues Different ways and models to implement 5
6 Different approaches Traceability
7 In the EU 7
8 Why the EU FMD? EU Falsified Medicine Directive 2011/62/EU (FMD) EU Commission Delegated Regulation 2016/161 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 antitampering device on the packaging of certain medicinal products for human use for the purposes of allowing their identification and authentication. 8
9 EU FMD at a glance 1. Safety Features 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). Verification - Repository system 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 2. Active substance quality 3. Online pharmacies 9
10 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 10
11 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 11
12 The EU Unique Identifier 12 Source: EU Commission Stakeholder Meeting, Copyright February GS AISBL, All Rights Reserved.
13 GS1 linear and 2D barcode Item identifier Expiry date (21)123 Batch number Serial number 13
14 GS1 Application Identifiers 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 Serial Number up to 20 characters - alphanumeric Sequence: GTIN first - then recommend to have fixed length - followed by variable length 14
15 Keep yourself informed 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? 15
16 Verification - Repository system: European Stakeholder Model (ESM) A pan-european end-to-end system enabling medicines to be verified at point of dispensing. Source ESM presentations 41
17 Need to be active at the national level The time to act is now 17
18 31 st Global GS1 Healthcare Conference 4 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 visits Participation free for regulatory bodies and hospitals GS1 2017
19 Questions? 19
20 Contact Details Geraldine Lissalde Bonnet Director Public Policy Healthcare GS1 Global Office, Brussels E geraldine.lissalde.bonnet@gs1.org W GS1 2017
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