Getting lost in all the talk of serialisation deadlines? Lars Olsen, Global Technology Partner in assembly and pack, has created a clear overview of timelines across the world to help you keep track of deadlines relevant to you.
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