Global Serialization & Trends
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Mr. Lars Olsen has over 25 years of experience in pharmaceutical packaging. He provides an overview of global serialization trends from 2017 to 2023. Most major markets will require serialization, aggregation, and reporting by law in this period. By 2019, over 40 countries representing 80% of the global market will have regulations in place. The document outlines expected timelines for implementation in various regions including Europe, Asia, North and South America, the Middle East, and the rest of the world.
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Global Serialization & Trends
- 2. Biography Mr. Lars Olsen • Dept. Global Best Practise, 2165 • Global Technology Partner, NNE • +25 years experience within Pharmaceutical Packaging • Production, Management, Project handling, GMP and Consulting • e-mail: lao@nne.com • Phone: +45 30757362
- 3. Summary Overview +40 countries and +80% of marked by 2019 2017 2018 2019 2020 2021 2022 2023 France Turkey Belgium Italy Denmark European Union Greece Europe Serialization Can wait until 2023 Serialization, Aggregation, reporting by law Serialization, ATD and reporting by law, Aggregation by business. Coding Serialization and reporting by law, Aggregation by business. 1) 2) 3) 1) 2) 09.FEB.2019
- 4. Summary Overview +40 countries and +80% of marked by 2019 2017 2018 2019 2020 2021 2022 2023 Asia Coding China India Pakistan Pakistan Serialization. NBA products only Australia Serialization, Aggregation, reporting by law Serialization, ATD and reporting by law, Aggregation by business. Serialization and reporting by law, Aggregation by business. 1) 2) 3) 1) 1) 1) Australia Australia Serialization all. Expected 2 – 5 years after NBA Japan Coding. Special products Japan Coding. All products Japan Coding. All products Ramp up Philippines Coding Voluntary South Korea 2) Taiwan Serialization Taiwan Coding
- 5. Summary Overview +40 countries and +80% of marked by 2019 2017 2018 2019 2020 2021 2022 2023 North / South America Serialization, Aggregation, reporting by law Serialization, ATD and reporting by law, Aggregation by business. Serialization and reporting by law, Aggregation by business. 1) 2) 3) 27.NOV.2019 US US Lot Tracking US Serialization, aggregation by business US E-Lot & Serialization 1) 27.NOV.2023 Coding. Voluntary Serialization Canada Canada Adaption of US FDA Guidelines expected ATD by US Pharmacopeia compliance 27.NOV.2017 Argentina Brazil Mexico Serialization, reporting expected Brazil Pilot starts Pilot ends Brazil Pilot concluded Brazil Full rollout 1) 3) Scope update by positive list
- 6. Summary Overview +40 countries and +80% of marked by 2019 2017 2018 2019 2020 2021 2022 2023 Middle East Serialization, Aggregation, reporting by law Serialization, ATD and reporting by law, Aggregation by business. Serialization and reporting by law, Aggregation by business. 1) 2) 3) Saudi Arabia UAE Oman Coding Jordan Egypt Algeria Serialization by label Algeria Serialization by print Serialization 12.MAR.2017 Saudi Arabia 3) Expected development in 2 – 3 years GCC 01.JUN.2017 Coding Jordan 30.JUN.2018 Coding Migration period Jordan Start 2020 Serialization 31.DEC.2017 Oman Serialization 31.DEC.2018 Coding UAE Serialization Expected development in 2 – 3 years 3) 2020+ Expected to develop into a new GCC standard, adapted by other Arab markets Coding Egypt Serialization Egypt 1) 30.JUN.2018 30.JUN.2019
- 7. Summary Overview +40 countries and +80% of marked by 2019 2017 2018 2019 2020 2021 2022 2023 RoW Serialization, Aggregation, reporting by law Serialization, ATD and reporting by law, Aggregation by business. Serialization and reporting by law, Aggregation by business. 1) 2) 3) Ukraine Serialization On hold European Union MoH would prefer alignment with EU Russia 1) 01.JAN.2017 Voluntary pilot initiated Russia 01.JAN.2018 Product group 1 Russia 01.JAN.2019 Product group 2 Russia 01.JAN.2020 Product group 3
- 8. 8 “Hello World” May 2006 I love deadlines. I like the whooshing sound they make as they fly by. Douglas Adams (Hitchhikers Guide to the Galaxy)