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Global
serialization
deadlines
9 Feb. 2017 / Lars Olsen
Summary overview
+80% of market 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
Summary overview
+80% of market 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
Summary overview
+80% of market 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
Summary overview
+80% of market 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
Summary overview
+80% of market 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

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Serialisation timelines

  • 2. Summary overview +80% of market 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
  • 3. Summary overview +80% of market 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
  • 4. Summary overview +80% of market 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
  • 5. Summary overview +80% of market 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
  • 6. Summary overview +80% of market 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