Serializations Rules Updates from EU and rest of the world

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Francesco Ricci
7 anni fa
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1 Serialization and Good Distribution Practices: Regulatory Impacts, Opportunities and Criticalities for Manufacturers and Drugs Distribution Chain Giada Necci New Solution Specialist GS1 Italy Indicod-Ecr Serializations Rules Updates from EU and rest of the world ISPE Italian Affiliate Bologna, April

2 GS1 Italy Indicod-Ecr GS1 Italy Indicod-Ecr è una associazione senza scopo di lucro che riunisce imprese di beni di consumo. Offre soluzioni concrete come i Sistemi standard GS1. Il più conosciuto è il codice a barre, usato in Italia e in oltre 110 paesi al mondo, permette lo scambio di informazioni tra Industria e Distribuzione con chiarezza, semplicità e senza errori. Offre inoltre tecniche, strumenti, strategie operative. Sono i Processi condivisi ECR. Nascono dal dialogo e dal confronto tra Industria e Distribuzione e hanno come obiettivo l efficienza e l innovazione nella filiera.

3 GS1 in the world 111 MO 1,300,000 Companies 150 Countries 2,500 People

4 GS1 System Enable visibility and efficency through the supply chain GTIN GLN sgtin SSCC Barcode EAN-13, ITF-14, GS1 128 GS1 Databar, GS1 DataMatrix, GS1 QR Code EPC Tag EDI GDSN GS1 Source EPCIS

5 Regulations Index of the presentation Implemented solutions at international level: Europe and the rest of the word

6 Requirements for Healthcare actors Enable Patient safety Dispensing errors Counterfeiting Track and Trace Recall/Withdrawal Regulations Client s requirements

7 Different attention points Identification and serialization Package level: secondary package, case/shipper,

8 Different attention points Communication system and info repositories Safety features

European Union FMD directive 2011 Delegated Acts 2015 Member States Implementation 2018/2024 Regulations in Europe Denmark Product Code 2012 DataMatrix or Barcode for some products 2014/2015 UK

9 European Union FMD directive 2011 Delegated Acts 2015 Member States Implementation 2018/2024 Regulations in Europe Denmark Product Code 2012 DataMatrix or Barcode for some products 2014/2015 UK Product Code 2012 Slovenia DataMatrix Barcode 2018 The Netherlands Product Code 2012 France Product Code, Batch Number and Exp Date 2011 Italy New Bollino 2016 Cyprus Product code 2010 Ukraine Serialization 2017 Serbia Traceability Regulation 2010 Turkey Track & Trace 2010

62/2011 EU Directive 10 th of Dec 2008 16 th of Feb 2011 Falsified medicinal products *** Committee on the Environment, Public Health and Food Safety PE430.

10 62/2011 EU Directive 10 th of Dec th of Feb 2011 Falsified medicinal products *** Committee on the Environment, Public Health and Food Safety PE European Parliament legislative resolution of 16 February 2011 on the proposal for a directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source (Ordinary legislative procedure: first reading)

11 Waiting for Delegated Acts

62/2011 EU Directive timeline 2011 2012 2013 2014 2015 2016 2017 2018 16 th of Febraury Voto EU 18 th of November Delegated Acts

12 62/2011 EU Directive timeline th of Febraury Voto EU 18 th of November Delegated Acts Concept Paper Adoption by Member States Q (?) Delegated Acts publication 2018 (?) 2024 (?) Member States implementation

13 The coding situation in Europe today 18 countries use a GS1 GTIN UK, Ireland, Czech Republic, Slovakia, Latvia, Lithuania, Estonia, Malta, Netherlands, Turkey, Romania, Bulgaria, Serbia, Albania, Bosnia and Herzegovina, Macedonia, Croatia 5 countries use an NTIN (National Identification Code on a GS1 structure) Austria, France, Greece, Slovenia, Spain 7 countries allow the use both of the GS1 GTIN and NTIN DK, Finland, Iceland, Norway, Poland, Sweden, Switzerland 4 countries use a national solution (NO GS1 compliant) Belgium, Germany (in combination with a NTIN), Italy, Portugal

14 GTIN and NTIN Global and unique Manufacturer Identifier Product Identifier

15 The move towards harmonisation and GS1 standards in Europe 30 countries already allow the use of GS1 standards 4 countries have a national solution not GS1 compliant Belgium and Germany: tested solution GS1 compliant and they are trying to align their solutions with the use of GS1 standards Italy and Portugal: no information available related activities of alignment to GS1 standards

16 Solutions to new requirements: NHRN NHRN: National Healthcare Reinbursement Number, with a GTIN for the Trade Unit. (71*) AS4562G9315 Application Identifier NHRN

17 Ukraine Standard Product Identification (GTIN), serial number, batch number and expiry date DataMatrix Secondary package Central and national repository

18 and the rest of the world Different requirements: Coding, serialization, use of Datamatrix, aggregation, data sharing Different status: Regulation and Law in place, Tender requirements, Important developments, Emerging needs Countries involved (from 2010 to 2023): USA, Argentina, India, Canada, China, Korea, Japan, Nigeria, Chile, Kenya, Singapore, Philippines, Saudi Arabia, Iran, Brazil, Taiwan, Mexico, Jordan Colombia, Libya, South Africa, UAE

19 Identification of pharmaceuticals Countries accepting a GTIN: Canada, Mexico, Costa Rica, South America (except Guyana, Suriname, Franch Guiana, Uruguay), Algeria, Libya, Egypt, South Africa, Israel, Jordan, Saudi Arabia, Syria, Iran, Russia, Kazakhstan, India, Myanmar, Thailand, Cambodia, Vietnam, Philippines, Australia, Malaysia, New Zealand, Taiwan, Ireland, UK, Netherlands, Switzerland, Denmark, Norway, Sweden, Finland, Ukraine, Estonia, latvia, Belarua, Poland, Czech Republic, Slovakia, Hungary, Croatia, Bosnia-Herz., Serbia, Slovenia Countries requiring a NTIN: USA, Spain, France, Greece, Austria, Romania, Moldavia, South Korea, Japan, Germany Countries requiring a National Identification: Portugal, Italy, Germany, Belgium, China

20 Serialisation of pharmaceuticals Countries requiring a serial number: USA, Brazil, Argentina, Italy, Belgium, Turkey, Greece, India, China Countries will require a serial number: EU Member States, Ukraine, South Korea, Saudi Arabia, Colombia

21 DataMatrix on pharmaceuticals Some countries require DataMatrix: USA, Argentina, France, Turkey, Jordan, Saudi Arabia, India, South Korea Some countries using DataMatrix in pilot or developing requirement for DataMatrix: Canada, Colombia, Brazil, EU Member States, Ukraine, Libya

22 Take-away points Standard identification + serialization. 2D Barcode: DataMatrix. Europe: Healthcare stakeholders are waiting for the Delegated Acts publication but proactivity is a necessity.

New Solution Specialist giada.necci@indicod-ecr.

23 Questions? Thanks! Per any information you should contact: Giada Necci New Solution Specialist Phone Mobile GS1 Italy Indicod-Ecr

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