IMPLEMENTAÇÃO DA DIRETIVA DOS MEDICAMENTOS FALSIFICADOS E ATOS DELEGADOS. Pedro Ferreira ANF

Size: px
Start display at page:

Download "IMPLEMENTAÇÃO DA DIRETIVA DOS MEDICAMENTOS FALSIFICADOS E ATOS DELEGADOS. Pedro Ferreira ANF"

Transcription

1 IMPLEMENTAÇÃO DA DIRETIVA DOS MEDICAMENTOS FALSIFICADOS E ATOS DELEGADOS Pedro Ferreira ANF

2

3

4 What are falsified medicines? Growing threat to public health and safety in Europe Counterfeit medicines seized at the outer border of the EU tripled between 2006 and 2009, reaching approximately 7.5 million items Over 30 million counterfeit medicines have been seized by customs at EU borders, internal and external, over the last five years Fake medicines may: Contain low quality ingredients or the wrong doses Have their identity or source deliberately mislabelled Have fake packaging or the wrong ingredients

5 Introduction of the Falsified Medicines Directive

6 Introduction of the Falsified Medicines Directive

7 10 Core Principles to Protect Patients from Falsified Medicines European Stekholder Model Parteners are set to consult and engage patient groups

8 European Stakeholder Model

9 European Stakeholder Model

10 European Stakeholder Model

11 The Nacional Blueprint approach

12 The Nacional Blueprint approach

13 Technology behind pharmacy Hub Command and Query Responsibility Segregation Secure Web services (REST) Cloud frontend HTML5 for Administration and monitorization

14 Which medicines should have Security Devices? RULE: All prescriptions medicines should have Security Device White List Black List Risk assessment Over the Counter with high risk of falsification Example: Omeprazole 20mg

15 Safety Features Anti-Tampering Device Safety Features Unique identifiers

16 Unique identifiers Unique identifiers - the sequence of numeric or alphabetic character per package, determinate by algorithm (max. 20) (serial number) - product code - national reimbursement or other number that identifies the product The unique identifier should be printed on the packaging in human-readable format, if possible near the two dimensional barcode: - serial number - product code - national reimbursement or other number that identifies the product

17 Unique identifiers Unique identifiers Authenticable Medicine Falsified medicine Who does the verification? Pharmacies (Community and Hospital), Distributors and Manufacturers

18 Unique identifiers When shall the verification /deactivation of the unique identifier done? Make sure that the unique identifier has the correct information and is legible Manufacturer Verifies the unique identifier and disactivate it before he changes it (parallel Importers)

19 Safety Features Tamper Evident Ensures that the packaging of the medicine was not opened or tampered Ensures the integrity of the product.

20 Safety Features Unique Identifier Bar Code RFID Code 2D Code Manufacturers should encode the unique identifier into a bar code (Two-dimensional). The 2D bar code must be a data matrix (data matrix), Machine-readable, printed on the package on a smooth surface, Uniform and slightly reflective

21 Safety Features

22 Repository System All the information about the Unique Identifiers Lies in the Repository System, enabling them to be checked and deactivated European HUB Nacional Repository OR Supranacional Repository

23 Portuguese Model Fits the blueprint model Most appropriate solution to the model of operation of Portuguese pharmacies More efficient, as it allows the use of existing technological infrastructures Facilitates interoperability with other technological systems medicines reimbursement

24 System Advantages Increased safety for manufacturers of Drugs that reach the Users

25 System Advantages Greater protection of citizens' health Less Fraud

26 Challenges Security of information and access to the repositories

27 Challenges Adaptation of the computer systems to all stakeholdes in the medicines circuit

28

EU IDMP Taskforce Falsified Medicines Directive and European Medicines Verification System Update

EU IDMP Taskforce Falsified Medicines Directive and European Medicines Verification System Update EU IDMP Taskforce Falsified Medicines Directive and European Medicines Verification System Update 19 th February 2016 EMA London Falsified Medicines February 9 th 2016 Delegated Regulation (EU) 2016/161

More information

Health systems and products Medical products quality, safety and innovation VERSION 8

Health systems and products Medical products quality, safety and innovation VERSION 8 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health systems and products Medical products quality, safety and innovation SAFETY FEATURES FOR MEDICINAL PRODUCTS FOR HUMAN USE QUESTIONS

More information

GS1 Ireland Healthcare User Group (HUG) Information Day

GS1 Ireland Healthcare User Group (HUG) Information Day 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 Overview on EU

More information

Verification of Pharmaceutical Products at the Point of Dispense. An EFPIA update

Verification of Pharmaceutical Products at the Point of Dispense. An EFPIA update Verification of Pharmaceutical Products at the Point of Dispense Speaker : Grant Courtney Event: GS1 Global Conference Location: Washington An EFPIA update 1 Who is EFPIA? The European Federation of Pharmaceutical

More information

The Blueprint approach

The Blueprint approach the way to comply with FMD and its Delegated Regulation: The Blueprint approach Johan Verhaeghe (FMD Project Manager) Frankfurt, 16 February 2016 EGA Vision 2020 To provide sustainable access to high quality

More information

Project responsibilities

Project responsibilities Project responsibilities Tallinn November 24th, 2017 Our Mission Falsified / counterfeit medicines are a serious risk for the citizens all around the world New legislation published on the 9th February

More information

Drug Supply Chain Security Act Implementation Track and Trace Issues in 2017

Drug Supply Chain Security Act Implementation Track and Trace Issues in 2017 Drug Supply Chain Security Act Implementation Track and Trace Issues in 2017 ILISA BG BERNSTEIN, PharmD, JD Deputy Director, Office of Compliance FDA/CDER Presented at: FDLI DQSA Conference November 15,

More information

Global Serialisation Developments and the Need for Convergence. Ulrike Kreysa, Vice-President, GS1 Global Office 3 rd June 2015

Global Serialisation Developments and the Need for Convergence. Ulrike Kreysa, Vice-President, GS1 Global Office 3 rd June 2015 Global Developments and the Need for Convergence Ulrike Kreysa, Vice-President, GS1 Global Office 3 rd June 2015 Developments across the world Regulatory bodies need to address Public Health issues one

More information

Mass Serialization and Traceability Implementation in the Pharma Industry. Mathieu Aman, Global Program Lead F. Hoffmann-La Roche Ltd, Switzerland

Mass Serialization and Traceability Implementation in the Pharma Industry. Mathieu Aman, Global Program Lead F. Hoffmann-La Roche Ltd, Switzerland Mass Serialization and Traceability Implementation in the Pharma Industry Mathieu Aman, Global Program Lead F. Hoffmann-La Roche Ltd, Switzerland What drives the industry towards more traceability Strategic

More information

Romania. Raluca Vasilescu Cabinet M Oproiu. Pharmaceutical Trademarks 2015/2016. A Global Guide

Romania. Raluca Vasilescu Cabinet M Oproiu. Pharmaceutical Trademarks 2015/2016. A Global Guide Romania Raluca Vasilescu Cabinet M Oproiu Pharmaceutical Trademarks 2015/2016 A Global Guide Romania Cabinet M Oproiu Author Raluca Vasilescu Selection, clearance and registration In Romania, pharmaceutical

More information

A global view from the Pharmaceutical Industry Mathieu Aman F. Hoffmann-La Roche Ltd, Basel (Switzerland)

A global view from the Pharmaceutical Industry Mathieu Aman F. Hoffmann-La Roche Ltd, Basel (Switzerland) Impressions Kaiseraugst A global view from the Pharmaceutical Industry Mathieu Aman F. Hoffmann-La Roche Ltd, Basel (Switzerland) SETRM2016 Rastreabilidade de Medicamento Sao Paulo, Jun 2016 Agenda Worldwide,

More information

European Medicines Verification Organisation: Requirements for the European Medicines Verification System URS Lite

European Medicines Verification Organisation: Requirements for the European Medicines Verification System URS Lite EMVO_0020 3.0 7/3/2017 1 of 51 European Medicines Verification Organisation: Requirements for the European Medicines Verification System URS Lite Copyright 2017 EMVO All rights reserved. Reproduction in

More information

GUIDANCE ON IMPLEMENTATION OF IDENTIFICATION AND BARCODING OF MEDICINAL PRODUCTS FOR HUMAN USE

GUIDANCE ON IMPLEMENTATION OF IDENTIFICATION AND BARCODING OF MEDICINAL PRODUCTS FOR HUMAN USE T.C. TURKISH MINISTRY OF HEALTH G.D. OF PHARMACEUTICALS AND PHARMACIES GUIDANCE ON IMPLEMENTATION OF IDENTIFICATION AND BARCODING OF MEDICINAL PRODUCTS FOR HUMAN USE Version 1.4 Ankara, 2011 Index Index...

More information

STATUS REPORT Status of the project to implement the Falsified Medicines Directive

STATUS REPORT Status of the project to implement the Falsified Medicines Directive STATUS REPORT 2017 Status of the project to implement the Falsified Medicines Directive 2 www.securpharm.de About securpharm e.v. securpharm e.v. is a nonprofit stakeholder organisation that develops the

More information

Saudi Drug Code (SDC), and Drug Barcoding Specifications

Saudi Drug Code (SDC), and Drug Barcoding Specifications Drug Sector Licensing Executive Directorate Guidance for Industry Saudi Drug Code (SDC), and Drug Barcoding Specifications This document outlines the SDC and the new drug barcode requirements for pharmaceuticals.

More information

Taking a Leap Toward Global Supply Chain Efficiency - Part II

Taking a Leap Toward Global Supply Chain Efficiency - Part II Taking a Leap Toward Global Supply Chain Efficiency - Part II 2 Supply Chain Brochure - Part II INTRODUCTION Pharmaceutical manufacturers face a number of challenges in the production and delivery of medicinal

More information

Barcodes on Unit of Use

Barcodes on Unit of Use Barcodes on Unit of Use 1 What hospitals need Hospitals need medications Ready-to-Administer In Unit-of-Use With Barcode 2 What hospitals need Ready-to-Administer If not, must go through additional pharmacy

More information

STATUS REPORT Status of the project to implement the Falsified Medicines Directive

STATUS REPORT Status of the project to implement the Falsified Medicines Directive STATUS REPORT 2018 Status of the project to implement the Falsified Medicines Directive 2 About securpharm e.v. securpharm e.v. is a nonprofit stakeholder organisation that develops the authentication

More information

Falsified Medicines Directive Info session for MAHs

Falsified Medicines Directive Info session for MAHs Falsified Medicines Directive Info session for MAHs 25/4/2017 14u 17u Auditorium at Wolubilis Agenda Welcome MAH responsibilities in FMD Products to market Q&A Interaction with the Verification system

More information

MAHs and CMOs considerations and objectives to meet upcoming regulations in 2019

MAHs and CMOs considerations and objectives to meet upcoming regulations in 2019 ARVATO SYSTEMS MAHs and CMOs considerations and objectives to meet upcoming regulations in 2019 Pascal Leppich, Arvato Systems Joseph Tshimbalanga, Systec & Services Abcoude, 22 June 2017 The WINDOW is

More information

The UDI Experience: From a US Perspective

The UDI Experience: From a US Perspective Simposio Nazionale Bergamo, Italy Saturday 6 May 2017 The UDI Experience: From a US Perspective Lena Cordie Qualitas Professional Services 2017 Qualitas Professional Services, LLC. All rights reserved.

More information

ENCODING, PRINTING & VALIDATING RFID TAGS WITH PORTALTRACK

ENCODING, PRINTING & VALIDATING RFID TAGS WITH PORTALTRACK ENCODING, PRINTING & VALIDATING RFID TAGS WITH PORTALTRACK Maximizing Your RFID Investment with PortalTrack from MSM Solutions MSM Solutions PortalTrack gives you the freedom to tailor your RFID and Barcode

More information

EAHP STATEMENT ON THE NEED FOR BARCODING OF THE SINGLE DOSE ADMINISTERED IN HOSPITALS

EAHP STATEMENT ON THE NEED FOR BARCODING OF THE SINGLE DOSE ADMINISTERED IN HOSPITALS EAHP STATEMENT ON THE NEED FOR BARCODING OF THE SINGLE DOSE ADMINISTERED IN HOSPITALS JUNE 2012 (UPDATED FROM 2007 & 2010 STATEMENTS) What is meant by barcoding of the single dose? By single dose EAHP

More information

GS1 Healthcare - Discussion paper on multi-market packs for pharmaceutical products

GS1 Healthcare - Discussion paper on multi-market packs for pharmaceutical products Purpose This GS1 Healthcare paper has been written to help demonstrate ways in which GS1 bar codes can be used to minimise the need for multiple bar codes to appear on product packaging while still enabling

More information

Automated English Translation of Brazil RDC using Google Translate NATIONAL HEALTH SURVEILLANCE AGENCY

Automated English Translation of Brazil RDC using Google Translate NATIONAL HEALTH SURVEILLANCE AGENCY using Google Translate Provided by RxTrace for discussion only. Do not base your compliance activities on this unofficial machine-translation. May 19, 2017 Note that this version of RDC-157 is intended

More information

Serialization and epedigree: New Opportunities for Life Sciences Manufacturers

Serialization and epedigree: New Opportunities for Life Sciences Manufacturers Serialization and epedigree: New Opportunities for Life Sciences Manufacturers Table of Contents Serialization and epedigree: Current Direction... 3 Why Invest in Serialization?... 3 What Tasks do Life

More information

Security Engineering Services. Scalaris GRC Day 2011

Security Engineering Services. Scalaris GRC Day 2011 Scalaris GRC Day 2011 Wednesday Feb. 2 nd 2011 11/01/2011 1 Presentation of Vesdo 11/01/2011 2 About Vesdo As internationally operating consulting engineers we exclusively focus on layout and realization

More information

Indian medicine manufacturer Medreich PLC improves production and quality with coding solutions from Videojet

Indian medicine manufacturer Medreich PLC improves production and quality with coding solutions from Videojet Thermal Inkjet Medreich PLC Case Study Indian medicine manufacturer Medreich PLC improves production and quality with coding solutions from Videojet Medreich PLC is a fully integrated pharmaceutical company

More information

Presse-Information Press release Information de presse

Presse-Information Press release Information de presse Presse-Information Press release Information de presse Kontakt/Contact: Dr. Kathrin Rübberdt Tel. ++49 (0) 69 / 75 64-2 77 Fax ++49 (0) 69 / 75 64-2 72 e-mail: presse@dechema.de Trend Report February 2018

More information

GS1 Turkey Yeliz Geriş. İTS -Turkish Pharmaceutical Track and Trace System

GS1 Turkey Yeliz Geriş. İTS -Turkish Pharmaceutical Track and Trace System GS1 Turkey Yeliz Geriş İTS -Turkish Pharmaceutical Track and Trace System What is İTS? İTS-Pharmaceutical Track & Trace System Project Phases Implementation Timeline Objectives Scope Labeling Workflow

More information

Medicine Traceability & AUthenticity

Medicine Traceability & AUthenticity Medicine Traceability & AUthenticity Overview Universidad de Belgrano 18 Mayo, 2010 1 Universidad de Belgrano Medicine Traceability Overview 18 Mayo, 2010 1. A Glance on CTP 2. Introduction 3. Good and

More information

GS1 Guide on Unique Device Identification (UDI) implementation

GS1 Guide on Unique Device Identification (UDI) implementation GS1 Guide on Unique Device Identification (UDI) implementation This document aims at providing clarification to questions raised by the industry as well as implementation guidance on the use of GS1 standards.

More information

GS1 Healthcare Newsletter

GS1 Healthcare Newsletter No. 25 Q4 2012 table of contents Special feature: GS1 Healthcare Conference Gathers in Lisbon 1 GS1 Healthcare takes the stage in Lisbon 1 McKinsey & Company reports on the benefits a single global standard

More information

notifications regarding Anti Counterfeit Labelling Solutions

notifications regarding Anti Counterfeit Labelling Solutions Implications of recent notifications regarding Anti Counterfeit Labelling Solutions Harveer Sahni CEO, MD, Weldon Celloplast Limited info@weldoncelloplast.com ll l http://harveersahni.blogspot.com P: 01125740089

More information

Pharmaceutical Packaging

Pharmaceutical Packaging Pharmaceutical Packaging 2017 2021 Section I: Introduction A. Pharmaceuticals defined B. Pharmaceutical packaging defined C. Study organization D. Methodology E. Geographic regions F. Conventions Section

More information

The world of GS1 standards in healthcare. Chris Adcock GS1 Global Office

The world of GS1 standards in healthcare. Chris Adcock GS1 Global Office The world of GS1 standards in healthcare Chris Adcock GS1 Global Office Topics Background Where we are going Where we are today What this means to you Questions Background Topics Where we are going Where

More information

Brand Protection: In the face of mounting counterfeiting, diversion & other infringements. Jim Mentone Director, Consumer Global Brand Protection

Brand Protection: In the face of mounting counterfeiting, diversion & other infringements. Jim Mentone Director, Consumer Global Brand Protection Brand Protection: In the face of mounting counterfeiting, diversion & other infringements Jim Mentone Director, Consumer Global Brand Protection Objective: Create active collaboration group MFGs & Retailers:

More information

Collaboration: GS1 and Joint Initiative Council (JIC) in Healthcare

Collaboration: GS1 and Joint Initiative Council (JIC) in Healthcare Collaboration: GS1 and Joint Initiative Council (JIC) in Healthcare International Organisation for Standardization European Committee for Standardization Health Level 7 international International Health

More information

Health Care/Pharmaceutical. GS1 Standards for Serialization and Visibility Within the U.S. Pharmaceutical Supply Chain

Health Care/Pharmaceutical. GS1 Standards for Serialization and Visibility Within the U.S. Pharmaceutical Supply Chain 1 Health Care/Pharmaceutical GS1 Standards for Serialization and Visibility Within the U.S. Pharmaceutical Supply Chain 2 Health Care/Pharmaceutical: GS1 Standards for Serialization and Visibility Within

More information

Serialization a global approach. Emanuele Tellaroli Key Account Manager ANTARES VISION

Serialization a global approach. Emanuele Tellaroli Key Account Manager ANTARES VISION Serialization a global approach Emanuele Tellaroli Key Account Manager ANTARES VISION Beirut 02 June 2016 Serialization concept THE SMALLEST ITEM PUT ON SALE (selling unit) IS IDENTIFIED BY THE COMBINATION

More information

10 steps to GS1 barcode implementation. User Manual

10 steps to GS1 barcode implementation. User Manual 10 steps to GS1 barcode implementation User Manual Issue 3, August 2016 Table of Contents Introduction... 3 1 Get a GS1 company prefix... 4 2 Assign numbers... 4 3 Select a barcode printing process...

More information

Welcome to our 29 th Global GS1 Healthcare Conference. Follow us on Twitter and tweet about the #GS1HCuae

Welcome to our 29 th Global GS1 Healthcare Conference. Follow us on Twitter and tweet about the #GS1HCuae Welcome to our 29 th Global GS1 Healthcare Conference Follow us on Twitter and tweet about the conference! @GS1Healthcare #GS1HCuae Welcome to the conference 29 th Global GS1 Healthcare Conference Dubai,

More information

The role of the European Commission during the FMD implementation phase Agnès Mathieu DG SANTE European Commission

The role of the European Commission during the FMD implementation phase Agnès Mathieu DG SANTE European Commission The role of the European Commission during the FMD implementation phase Agnès Mathieu DG SANTE European Commission 1st EMVO-MS Workshop 13 December 2016 Delegated Regulation on the Safety Features Adoption

More information

Identification and Marking of multi-market packs

Identification and Marking of multi-market packs Identification and Marking of multi-market packs Ask the expert Grant Courtney April 2015 Introduction Grant Courtney - Member of GS1 Healthcare Leadership Team - Co-author of the GS1 discussion paper

More information

Healthcare GTIN Allocation Rules

Healthcare GTIN Allocation Rules Healthcare GTIN Allocation Rules GS1 Global Healthcare User Group 03 October 2007, Final All contents copyright GS1 2007 Page 1 of 25 Document Summary Document Item Document Title Current Value Healthcare

More information

New Barcode, New Functionality

New Barcode, New Functionality New Barcode, New Functionality Head Office in United Kingdom Regional Offices in France, South Africa, Spain, USA BARCODES ARE CHANGING The correct name for a barcode is a machine readable symbol. Quite

More information

Security challenges for RFID key applications

Security challenges for RFID key applications 3rd European Workshop on RFID Systems and Technologies 12./13. June 2007, Duisburg Security challenges for RFID key applications Ulrich Waldmann Fraunhofer-Institut SIT Content Discussion of product anti-counterfeiting

More information

Charter on Access to Health in Developing Countries

Charter on Access to Health in Developing Countries Charter on Access to Health in Developing Countries Fake Medicines July 2014 Our Promise Merck is a leading company for innovative and top-quality high-tech products. As the oldest pharmaceutical and chemical

More information

Visions of new responsibilities and opportunities for terminologists and terminology centres

Visions of new responsibilities and opportunities for terminologists and terminology centres Visions of new responsibilities and opportunities for terminologists and terminology centres Katri Seppälä, Director, Finnish Terminology Centre TSK Virpi Kalliokuusi, Senior Planning Officer, National

More information

Validation and Verification of Supply Chain: End-to-End Karen S Ginsbury For IVT: Workshop C 28 October :30 12:00

Validation and Verification of Supply Chain: End-to-End Karen S Ginsbury For IVT: Workshop C 28 October :30 12:00 Validation and Verification of Supply Chain: End-to-End Karen S Ginsbury For IVT: Workshop C 28 October 2014 08:30 12:00 Pangea 7 May 2014 Israel ONLY Pangea 7 May 2014 Israel ONLY Pangea 7 May 2014 Israel

More information

ASK THE EXPERTS GS1 DataMatrix

ASK THE EXPERTS GS1 DataMatrix ASK THE EXPERTS GS1 DataMatrix The Basics and an Example Implementation GS1 Healthcare Conference Budapest 21 October 2015 Ask the Experts GS1 DataMatrix Today s presenters GS1 DataMatrix The Basics -

More information

Ensure barcode and printed text quality with machine vision verification

Ensure barcode and printed text quality with machine vision verification Ensure barcode and printed text quality with machine vision verification 1 Presented by Jonathan Ludlow Machine Vision Promoter at Microscan Sadie Zeller Product Manager at Microscan 2 About Microscan

More information

Corporate Presentation & Offer for SAP ATTP December 2015

Corporate Presentation & Offer for SAP ATTP December 2015 Corporate Presentation & Offer for SAP ATTP December 2015 Page : 1 Page : 2 Content Our Vision Our Company Business Challenges SAP Advanced Track and Trace for Pharmaceuticals (ATTP) Our Offer Our Vision

More information

Pharmaceutical RFID: From Mandates to Endorsements and Laws

Pharmaceutical RFID: From Mandates to Endorsements and Laws Pharmaceutical RFID: From Mandates to Endorsements and Laws By Sara Shah, Industry Analyst, RFID and M2M Research, ABI Research The healthcare industry s motivation for adopting RFID can be attributed

More information

Provided by TryEngineering - Click here to provide feedback on this lesson.

Provided by TryEngineering -  Click here to provide feedback on this lesson. Provided by TryEngineering - Click here to provide feedback on this lesson. Lesson Focus Lesson focuses on how computerized barcodes have improved efficiency in product distribution; explores the barcoding

More information

APPLICATION WHITE PAPER

APPLICATION WHITE PAPER New Pharmaceutical Marking Guidelines and Opportunities Tips, techniques and technologies for implementing unit-of-use bar code, anti-counterfeiting and RFID labeling to improve patient safety, satisfy

More information

National Blueprint System Slovakia Kick-Off Meeting

National Blueprint System Slovakia Kick-Off Meeting National Blueprint System Slovakia Kick-Off Meeting Bratislava November 22th, 2017 Nov. 22th, 2017 Kick-Off SOOL 1 Agenda Arvato Architecture NMVS Web Service Interface Roles and Rights Onboarding Project

More information

Nordic Instructions for Nordic Article Numbers (Vnrs) Supplementary information Norway. 1. The flow of article information

Nordic Instructions for Nordic Article Numbers (Vnrs) Supplementary information Norway. 1. The flow of article information 1 Nordic Instructions for Nordic Article Numbers (s) Supplementary information Norway This document presents an overview on the handling of s (Varenummer/article number) and information carried by the

More information

An industry perspective on medicines barcoding and bedside scanning

An industry perspective on medicines barcoding and bedside scanning An industry perspective on medicines barcoding and bedside scanning Chris Dierickx Manager Business Development - Pfizer Global Supply Puurs Monday the 14 th of October 2013 Content Introduction Pfizer

More information

GS1 Ireland Healthcare User Group (HUG) Information Day

GS1 Ireland Healthcare User Group (HUG) Information Day GS1 Ireland Healthcare User Group (HUG) Information Day FMD Implementation challenges for the manufacturers Joan Cahill, Pfizer 28 th March 2017 FMD Implementation Challenges Industry Perspective Joan

More information

CYTOTOXIC TRACEABILITY AND PATIENT WRISTBANDS

CYTOTOXIC TRACEABILITY AND PATIENT WRISTBANDS CYTOTOXIC TRACEABILITY AND PATIENT WRISTBANDS Pr Pascal BONNABRY Head of pharmacy Global GS1 Healthcare Conference Dubai, April 18, 2016 Introduction A full traceability of the medication process is the

More information

Case Study: how reports of falsified medicinal products can impact wholesale distributors

Case Study: how reports of falsified medicinal products can impact wholesale distributors Case Study: how reports of falsified medicinal products can impact wholesale distributors Amy Kelly Ph.D. Wholesale Distribution Conference 11 th November 2014 Overview Legal basis Falsified medicine issues

More information

INSTANT TICKET GAME RULES AND GUIDELINES

INSTANT TICKET GAME RULES AND GUIDELINES INSTANT TICKET GAME RULES AND GUIDELINES INSTANT TICKET GAME #858 $250,000 CLUB SECTION 1 - PURPOSE OF GUIDELINES These game specific rules and guidelines are issued pursuant to Iowa Code Section 99G.9

More information

IHE Pharmacy Technical Framework Supplement. Uniform Barcode Processing (UBP) Rev. 1.0 Draft for Public Comment

IHE Pharmacy Technical Framework Supplement. Uniform Barcode Processing (UBP) Rev. 1.0 Draft for Public Comment Integrating the Healthcare Enterprise 5 IHE Pharmacy Technical Framework Supplement 10 Uniform Barcode Processing (UBP) 15 HL7 FHIR STU 3 Using Resources at FMM Level 2-5 Rev. 1.0 Draft for Public Comment

More information

delivered to your desktop

delivered to your desktop E NT ER PR I SE ID SOlutions GUIDE Enterprise-class performance delivered to your desktop the importance of secure identity Information is shared across the world in mere seconds with the click of a mouse

More information

Labeling Best Practice in a Challenging Manufacturing Landscape A survival guide for pharmaceutical companies

Labeling Best Practice in a Challenging Manufacturing Landscape A survival guide for pharmaceutical companies Labeling Best Practice in a Challenging Manufacturing Landscape A survival guide for pharmaceutical companies White Paper www.nicelabel.com/pharma 1 1 Executive summary The number of challenges for the

More information

Live Demonstration The Auto ID Technologies & In-House Systems for UDI Compliance Brought to you by the AIM North America Healthcare Committee

Live Demonstration The Auto ID Technologies & In-House Systems for UDI Compliance Brought to you by the AIM North America Healthcare Committee Live Demonstration The Auto ID Technologies & In-House Systems for UDI Compliance Brought to you by the AIM North America Healthcare Committee Slide 1 Bar Code AIM represents Automatic Identification and

More information

GOVERNMENT SECURITY SOLUTIONS SECURE MARKING, AUTHENTICATION, TRACKING AND TRACING TO ASSIST CUSTOMS. Christophe Renard. WCO IT Conference Brisbane

GOVERNMENT SECURITY SOLUTIONS SECURE MARKING, AUTHENTICATION, TRACKING AND TRACING TO ASSIST CUSTOMS. Christophe Renard. WCO IT Conference Brisbane GOVERNMENT SECURITY SOLUTIONS SECURE MARKING, AUTHENTICATION, TRACKING AND TRACING TO ASSIST CUSTOMS Christophe Renard WCO IT Conference Brisbane May 2014 SICPA Security Solutions May 2014 - n 2 CASE STUDIES

More information

GS1 in Europe Logistic Label

GS1 in Europe Logistic Label version 14 updated: 07.03.2007 www.gs1.org The global language of business DOCUMENT CHANGE HISTORY (WITH REFERENCE TO PREVIOUS VERSION) Date of Change Summary of Change Changed by: 07.03.2007 07.03.2007

More information

Healthcare. Frequently Asked Questions (FAQs) by the Pharmaceutical Industry in Preparing for the U.S. DSCSA

Healthcare. Frequently Asked Questions (FAQs) by the Pharmaceutical Industry in Preparing for the U.S. DSCSA Healthcare Frequently Asked Questions (FAQs) by the Pharmaceutical Industry in Preparing for the U.S. DSCSA Release 1.0, May 23 2017 Table of Contents 1 Introduction... 7 2 IDENTIFY: Questions about GS1

More information

MGM Brakes Label Specifications. The following label standards are to provide a uniform implementation and integration of material management:

MGM Brakes Label Specifications. The following label standards are to provide a uniform implementation and integration of material management: 6.2 Label Standards The following label standards are to provide a uniform implementation and integration of material management: 1. The minimum size of the standard MGM Brakes part identification label

More information

Global Forum on Competition

Global Forum on Competition Unclassified DAF/COMP/GF/WD(2014)51 DAF/COMP/GF/WD(2014)51 Unclassified Organisation de Coopération et de Développement Économiques Organisation for Economic Co-operation and Development 14-Feb-2014 English

More information

Pfizer s Pedigree & RFID Pilots An Overview

Pfizer s Pedigree & RFID Pilots An Overview An Overview Granada, February 2008 Tim Marsh Senior Manager Pfizer V-Tag C-Tag Pedigree Pilots Ongoing Work and Collaboration V-Tag Viagra RFID Pilot Mass Serialization at Item, Case and Pallet Level via

More information

Securikett Position Paper - Security Labels to Comply with Directive 2011/62/EU

Securikett Position Paper - Security Labels to Comply with Directive 2011/62/EU Securikett Position Paper - Security Labels to Comply with Directive 2011/62/EU Dr. Marietta Ulrich-Horn, MBA Version 5, January 2012 Table of Contents Table of Contents... 1 Executive Summary... 2 1 The

More information

Digitally Connected RAIN Embedded Solutions for IoT Eric Wood, VP Product Management, Printed Electronics

Digitally Connected RAIN Embedded Solutions for IoT Eric Wood, VP Product Management, Printed Electronics Digitally Connected RAIN Embedded Solutions for IoT Eric Wood, VP Product Management, Printed Electronics That s quite a mouthful what does it mean? Digitally Connected Information is available when needed

More information

GUIDELINES ON STANDARDIZATION OF PAYMENT ORDERS AND DEMAND DRAFTS

GUIDELINES ON STANDARDIZATION OF PAYMENT ORDERS AND DEMAND DRAFTS GUIDELINES ON STANDARDIZATION OF PAYMENT ORDERS AND DEMAND DRAFTS STATE BANK OF PAKISTAN PAYMENT SYSTEMS DEPARTMENT Table of Contents A. Preamble... 3 B. Definitions... 3 1. Layout of Payment Orders and

More information

Guidelines for Bar Coding in the Pharmaceutical Supply Chain

Guidelines for Bar Coding in the Pharmaceutical Supply Chain HEALTHCARE DISTRIBUTION ALLIANCE Guidelines for Bar Coding in the Pharmaceutical Supply Chain Distributed by Cardinal Health, Inc. with permission from HDA HDA GUIDELINES FOR BAR CODING IN THE PHARMACEUTICAL

More information

WEBINAR SERIES #4 EPC/RFID STANDARDS AND RFID STUFF YOU NEED TO KNOW

WEBINAR SERIES #4 EPC/RFID STANDARDS AND RFID STUFF YOU NEED TO KNOW WEBINAR SERIES #4 EPC/RFID STANDARDS AND RFID STUFF YOU NEED TO KNOW STANDARDS AND RFID An Overview of GS1 Standards Identify, Capture, Share Serialization Basics and EPC The Next Level of Visibility Serial

More information

Product traceability offers opportunities for more visibility in pharmaceutical supply chains

Product traceability offers opportunities for more visibility in pharmaceutical supply chains Product traceability offers opportunities for more visibility in pharmaceutical supply chains White Paper Serialization Serialization in the pharmaceutical industry Content Serialization in the pharmaceutical

More information

TED Challenge: Tracking & Tracing Vaccines in the GAVI Alliance Supply Chain

TED Challenge: Tracking & Tracing Vaccines in the GAVI Alliance Supply Chain TED Challenge: Tracking & Tracing Vaccines in the GAVI Alliance Supply Chain 15 February 2013 Vaccines are a powerful but sensitive technology. They have to be stored at a certain temperature, or they

More information

SE09. Track & Trace Solutions Jeff Bredemus Werner Electric

SE09. Track & Trace Solutions Jeff Bredemus Werner Electric SE09 Track & Trace Solutions Jeff Bredemus Werner Electric Related Topics SE02 Balluff RFID SE03 Benefits of Image Based Barcode Reading SE08 Vision Solutions for the Food Ind. Solution Area 5 (Motion

More information

ECIA. Publication EIGP November Electronic Components Industry Association. Industry Guidelines EIGP

ECIA. Publication EIGP November Electronic Components Industry Association. Industry Guidelines EIGP ECIA Publication 2D Barcode Labeling Specification for Product Package and Shipments in the Electronics Industry (Including Human Readable and 1D Barcode) November 2012 Electronic Components Industry Association

More information

ehealth-strategien im Wettbewerb: Erfolgsfaktor oder schmückendes Beiwerk? ehealth Kongress Darmstadt, 17 Oktober 2014

ehealth-strategien im Wettbewerb: Erfolgsfaktor oder schmückendes Beiwerk? ehealth Kongress Darmstadt, 17 Oktober 2014 ehealth-strategien im Wettbewerb: Erfolgsfaktor oder schmückendes Beiwerk? ehealth Kongress Darmstadt, 17 Oktober 2014 Health care is in the middle of a perfect storm Changing demographics Unmet needs

More information

APIFARMA PORTUGUESE PHARMACEUTICAL INDUSTRY ASSOCIATION

APIFARMA PORTUGUESE PHARMACEUTICAL INDUSTRY ASSOCIATION APIFARMA PORTUGUESE PHARMACEUTICAL INDUSTRY ASSOCIATION 2017 ABOUT US Portuguese Pharmaceutical Industry Association Founded in 1975, succeeds the National Guild of the Manufacturers of Medicinal Products

More information

Implementation manual for barcoding using GS1 global standards for tracking and tracing of pharmaceuticals and drugs for exports

Implementation manual for barcoding using GS1 global standards for tracking and tracing of pharmaceuticals and drugs for exports Implementation manual for barcoding using GS1 global standards for tracking and tracing of pharmaceuticals and drugs for exports To facilitate compliance with DGFT Public Notice No. 59(RE-2010)/2009-2014

More information

Controlling Counterfeit Medications

Controlling Counterfeit Medications Controlling Counterfeit Medications A New Role for Pharmacists? Jane Nicholson BRAZIL 2006 1 2 INTERNATIONAL PHARMACEUTICAL FEDERATION FÉDÉRATION INTERNATIONALE PHARMACEUTIQUE Po Box 84200, 2508 AE The

More information

PRINCIPLES OF DESIGNING A MEDICATION LABEL FOR INJECTABLE SYRINGES FOR PATIENT SPECIFIC, INPATIENT USE

PRINCIPLES OF DESIGNING A MEDICATION LABEL FOR INJECTABLE SYRINGES FOR PATIENT SPECIFIC, INPATIENT USE PRINCIPLES OF DESIGNING A MEDICATION LABEL FOR INJECTABLE SYRINGES FOR PATIENT SPECIFIC, INPATIENT USE 200 Lakeside Drive, Suite 200 Horsham, PA 19044 www.ismp.org 215-947-7797 1 The risk of medication

More information

Pharmaceutical traceability in Brazil

Pharmaceutical traceability in Brazil Pharmaceutical traceability in Brazil Ms. Bianca Zimon Giacomini Ribeiro, Deputy Chief Adviser for International Affairs, National Agency of Sanitary Surveillance (Anvisa), Brazil 18 October 2017 GS1 2017

More information

DATA INTEGRITY ASSURANCE AS KEY FACTOR FOR SURVIVING CORPORATE AUDITS AND REGULATORY INSECTIONS

DATA INTEGRITY ASSURANCE AS KEY FACTOR FOR SURVIVING CORPORATE AUDITS AND REGULATORY INSECTIONS GLOBAL PROVIDER, LOCAL SOLUTIONS IN YOUR LANGUAGE DATA INTEGRITY ASSURANCE AS KEY FACTOR FOR SURVIVING CORPORATE AUDITS AND REGULATORY INSECTIONS Francesco Amorosi PhD Octorber 2017 DATA INTEGRITY & CSV:

More information

Next Generation Bar Codes For Small Package Labeling: Discussion Points

Next Generation Bar Codes For Small Package Labeling: Discussion Points Next Generation Bar Codes For Small Package Labeling: Discussion Points Authored by Health Industry Business Communications Council 2525 E. Arizona Biltmore Circle Suite 127 Phoenix, Arizona 85016 USA

More information

Vnr. Nordic Article Number. Instruction booklet Version: 1.7 1/23

Vnr. Nordic Article Number. Instruction booklet Version: 1.7 1/23 Vnr Nordic Article Number Instruction booklet Version 1.7 2017-05-10 Version: 1.7 1/23 History Date Version Comment Author 2013-03-25 1.0 New document Hans Andersson 2014-01-22 1.1 Changed names from Apotekens

More information

Local Authority and Provider welcome pack

Local Authority and Provider welcome pack Information Services provided by Business Services Authority Local Authority and Provider welcome pack Local Authority and Provider welcome pack (V1.5) 08.2016 Contents Introduction... 3 Setting up an

More information

KyoungjaLee. Korea Pharmaceutical Information Service (KPIS), Korea

KyoungjaLee. Korea Pharmaceutical Information Service (KPIS), Korea KyoungjaLee Korea Pharmaceutical Information Service (KPIS), Korea Pharmaceutical Serialization in Korea Pharmaceutical serialization policy & national traceability system KyoungjaLee, General Director

More information

Pharmaceutical Serialization: An Implementation Guide

Pharmaceutical Serialization: An Implementation Guide Pharmaceutical Serialization: An Implementation Guide By Joe Whyte, Global Serialization Lead, Rockwell Automation Global pharmaceutical companies lose an estimated $75 billion annually to counterfeit,

More information

Counterfeit prescription drugs 1

Counterfeit prescription drugs 1 Counterfeit prescription drugs 1 The World Health Organization (WHO) defines a counterfeit drug as: A medicine, which is deliberately and fraudulently mislabelled with respect to identity and/or source.

More information

How RFID Can Benefit Your Business Oracle Business World 1 st Dec 2005

How RFID Can Benefit Your Business Oracle Business World 1 st Dec 2005 How RFID Can Benefit Your Business Oracle Business World 1 st Dec 2005 Ing. Edwin W. Kalischnig MBA Director of Business Development RFID & Sensor Based Services Oracle Corporation - EMEA agenda Smart

More information

Barcodes and Symbology Basics for Machine Vision. Jonathan Ludlow Machine Vision Promoter Barbie LaBine Training Coordinator Microscan Systems Inc.

Barcodes and Symbology Basics for Machine Vision. Jonathan Ludlow Machine Vision Promoter Barbie LaBine Training Coordinator Microscan Systems Inc. Barcodes and Symbology Basics for Machine Vision Jonathan Ludlow Machine Vision Promoter Barbie LaBine Training Coordinator Microscan Systems Inc. Introduction, Topics, and Goals Who I am Introduce myself

More information

Text of the Russian Pharma Serialization and Tracing Pilot Guidelines as translated by Google Translate

Text of the Russian Pharma Serialization and Tracing Pilot Guidelines as translated by Google Translate 1 Text of the Russian Pharma Serialization and Tracing Pilot Guidelines as translated by Google Translate Provided by RxTrace for discussion only. Do not base your compliance activities on this unofficial

More information

Khanna S et al. IRJP 1 (1) COUNTERFEIT DRUGS: PROBLEMS AND SOLUTIONS Khanna Surabhi* 1, Nasa Atul 2, Garg Arun 3

Khanna S et al. IRJP 1 (1) COUNTERFEIT DRUGS: PROBLEMS AND SOLUTIONS Khanna Surabhi* 1, Nasa Atul 2, Garg Arun 3 INTERNATIONAL RESEARCH JOURNAL OF PHARMACY Available online http://www.irjponline.com Review Article COUNTERFEIT DRUGS: PROBLEMS AND SOLUTIONS Khanna Surabhi* 1, Nasa Atul 2, Garg Arun 3 1 E.C.member IPGA

More information