Coding Guidance

EU serialization

Author: Petra Kristic

August 2018

I Global Master Data Management

 Agenda

NTIN and GTIN formation rules

Examples

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NTIN formation rules

NTIN Markets NTIN formation rules

Austria 908888 + PZN (without last digit) + EAN check digit

France 3400 + CIP/ACL code + EAN check digit

Germany 4150 + 8-digit PZN + EAN check digit

Spain 847000 + Codigo Nacional + EAN check digit

Sweden, Denmark, Finland, Iceland, Norway 704626 + Nordic Drug Code issued by Nordic Number office + EAN check digit

7680 + Code assigned by Swissmedic (consists of 5 digits Product License number + 3

Switzerland (Liechtenstein)
digits Pack Size indicator) + EAN check digit

NTIN construct:

Packaging Indicator + Global Company Code (GCP) + National Code + Check digit (https://www.gs1.org/check-digit-calculator )

NTIN length = 14 digits

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Austria

National code used in Austria is 7 digit PZN (Pharmazentralnummer). Six digits of the PZN are for identifying specific items
whereas the seventh digit serves as check digit.

PZN XXXXXX Y check digit PZN

(Pharmazentralnummer)
PZN

Arge Pharma
Generating NTIN from PZN Packaging Indicator 0 90 8888 XXXXXX Y check digit PZN
Country Code PZN

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Austria

Product Code National Health Reimbursement Number (NHRN) Timing Conclusion

Member State Use Confirmatio Overview Number of

Human
GTIN Other On Pack In product Code In UI system n by Health human elements in
Readable
look-up Authority readable 2D barcode

NTIN with PZN Yes (NTIN with Not known 4 lines:

Austria – SMP* No No No No No 4
embedded PZN embedded) yet GTIN

NTIN with PZN

embedded (if
No, in case of Not known 4 lines:
Austria – MMP* No compatible No No No Yes 4
GTIN yet GTIN
with other
markets)

*SMP: Single Market Pack; MMP: Multi-Market Pack.

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Austria - example

NTIN construct:

Packaging Indicator + Global Company Code (GCP) + National Code + Check digit (
LINK)

NTIN length = 14 digits

Packaging Indicator: 0 (1 digit)

GCP: 908888 (6 digits)

National Code (PZN – without PZN check digit) : 126842 ( 6 digits)

Check Digit: 0 (1 digit)

NTIN example: 09088881268420

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Germany

National code used in Germany is 7 or 8 digit PZN (Pharmazentralnummer). If 7 digits  zero to be added in front to complete 8
digits

PZN XXXXXXX Y check digit PZN

(Pharmazentralnummer)
PZN

Packaging Indicator 0 4150 XXXXXXXX Y check digit NTIN

Generating NTIN from PZN
Country Code PZN

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Germany

Product Code National Health Reimbursement Number (NHRN) Timing Conclusion

Member Number
State Use Confirmation Overvie of
On In product Human
GTIN Other In UI system by Health w human elements
Pack Code Readable
look-up Authority readable in 2D
barcode
NTIN or PPN
Yes (NTIN or
Germany – (PZN 4 lines:
No Yes PPN with PZN Yes No No 4
SMP* embedded No GTIN
embedded)
in both)

No, in case of Yes, in case

5 lines:
Germany – PPN (PZN GTIN of GTIN
Yes Yes Yes No GTIN + 5
MMP* embedded) Yes, in case of No, in case
NHRN
PPN of PPN

*SMP: Single Market Pack; MMP: Multi-Market Pack.

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Germany - example
NTIN construct:

Packaging Indicator + Global Company Code (GCP) + National Code + Check digit (
LINK)

NTIN length = 14 digits

Packaging Indicator: 0 (1 digit)

GCP: 4150 (4 digits)

National Code (PZN) : 1686198 (7-8 digits 

if 7 digits a zero to be added in front to complete 8 digits)

Check Digit: 3 (1 digit)

NTIN example: 04150016861983

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France

The 13 - character ACL code structure is in use in France

Additional position for product families

ACL 13 code 3400 X YYYYYYY D check digit

ACL prefix Code ACL 7

Additional position for product families

Packaging Indicator 0 3400 X YYYYYYY D check digit

Generating NTIN from ACL 13 code
Country Code Code ACL 7
(ACL prefix)

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France

Product Code National Health Reimbursement Number (NHRN) Timing Conclusion

Member
State Use Confirmation Overview Number of
In product Human
GTIN Other On Pack In UI system by Health human elements in
Code Readable
look-up Authority readable 2D barcode

Maybe Yes (CIP

NTIN with CIP 4 lines:
France on Yes Yes mandatory No No Q4/2017 4
embedded No GTIN
MMP* on the pack)

France: Use of GTIN on multi market packs and look-up under discussion

*SMP: Single Market Pack; MMP: Multi-Market Pack.

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France - example
NTIN construct:

Packaging Indicator + Global Company Code (GCP) + National Code + Check digit (
LINK)

NTIN length = 14 digits

Packaging Indicator: 0 (1 digit)

GCP: 3400 (4 digits)

National Code (CIP/ACL) : 9 3491754 (7 digits + 1 digit  extended with an

additional position used to differentiate product Families (9)

Check Digit: 7 (1 digit)

NTIN example: 03400934917547

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Spain

National code used in Germany is 7 digit Codigo Nacional  last digit is the check digit.

CN XXXXXX. Y check digit

(Codigo Nacional) CN

Generating NTIN from CN Packaging Indicator 0 847000 XXXXXX Y check digit

Country Code CN

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Spain

Product Code National Health Reimbursement Number (NHRN) Timing Conclusion

Member
State Use Confirmation Overview Number of
In product Human
GTIN Other On Pack In UI system by Health human elements in
Code Readable
look-up Authority readable 2D barcode

Yes if a NTIN Yes (pre-

is used. If a printed by Either 4
GTIN is law on the Yes, Informative lines Either 4
NTIN (EAN13 used, NHRN upper right- if a Note of the (NTIN as lines (NTIN
Spain Yes with NHRN Yes is included hand corner GTIN No AEMPS PC) or 5 as PC) or 5
embedded) as 5th on the front is (published in lines lines (GTIN
element of of the box, used July 2017) (GTIN + + NHRN)
the 2D not close to NHRN)
barcode the barcode)

Spain: the Spanish Medicines Agency wants to have the National Health Reimbursement Number included in the data matrix. The NHRN
is a 6 digit number plus a control digit. It is embedded in EAN13 code (847000 + NHRN+ CD). The NHRN must also be printed on the upper
right-hand corner on the front of the box, not close to the bar code by law.

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Spain - example
NTIN construct:

Packaging Indicator + Global Company Code (GCP) + National Code + Check digit (
LINK)

NTIN length = 14 digits

Packaging Indicator: 0 (1 digit)

GCP: 847000 (6 digits)

National Code (Codigo Nacional) : 674689 (6 digits)

Check Digit: 9 (1 digit)

NTIN example: 08470006746899

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Nordics

National code used in Nordics (Denmark, Finland, Iceland, Norway, Sweden) is 6 digit Vnr (Nordisk Varennummer).

Vnr XXXXXX
(Nordisk Varennummer) Vnr

Packaging Indicator 0 704626 XXXXXX Y check digit NTIN

Generating NTIN from Vnr Country Code Vnr

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Denmark, Finland, Iceland, Norway, Sweden
Product Code National Health Reimbursement Number (NHRN) Timing Conclusion
Number of
Member State Use Confirmation Overview
In product Human elements
GTIN Other On Pack In UI system by Health human
Code Readable in 2D
look-up Authority readable
barcode
NTIN with Vnr Confirmed by 4 lines: GTIN
Denmark Yes No No No No No 4
embedded authorities 4 lines: no GTIN
NTIN with Vnr Most likely
Finland Yes No No No No No tbd tbd
embedded 4
NTIN with Vnr Most likely
Iceland Yes No No No No No tbd tbd
embedded 4
NTIN with Vnr Most likely
Norway Yes No No No No No tbd tbd
embedded 4
NTIN with Vnr 4 lines: GTIN
Sweden Yes No No No No No 4
embedded 4 lines: no GTIN

Denmark, Finland, Iceland, Norway, Sweden: GTIN for new products and NTIN for existing products (termination date for new NITNs is set on 09/02/2019). The Vnr is
not used as a NHRN and shall not be uploaded to the EU Hub as a National Code in the Market Specific Data. The Vnr is not affected by e-verification. It is an old
system which still is used but for other purposes. Whether a company will use a unique NTIN or a GTIN for e-verification doesn’t matter. It is only important that the
code is unique. The current NTIN can only be retained if it is unique to the pack (not always the case today in Sweden). In the NTIN, the Vnr is embedded but that is
not at any significance for e-verification. If a company change to GTIN as the unique product code, there is no impact on the Vnr, it can be kept (and is printed on the
pack) but of course it can never be embedded in the GTIN

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Sweden, Denmark, Finland, Iceland, Norway - example

NTIN construct:

Packaging Indicator + Global Company Code (GCP) + National Code + Check digit (
LINK)

NTIN length = 14 digits

Packaging Indicator: 0 (1 digit)

GCP: 704626 (6 digits)

National Code (Nordic Drug Code) : 078509 (6 digits)

Check Digit: 0 (1 digit)

NTIN example: 07046260785090

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Switzerland

National code used in Switzerland is 5 digit Swiss Medic code

Swissmedic XXXXX
Swiss Medic

Pack Size Indicator

Generating NTIN from Swissmedic Packaging Indicator 0 7680 XXXXX YYY D check digit

Country Code Swiss Medic

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 Switzerland - example
NTIN construct:

Packaging Indicator + Global Company Code (GCP) + National Code + Check digit (
LINK)

NTIN length = 14 digits

Packaging Indicator: 0 (1 digit)

GCP: 7680 (4 digits)

National Code (Code assigned by Swissmedic) : 55060 (5 digits) + Pack Size

Indicator 005 (3 digits)

Check Digit: 4 (1 digit)

NTIN example: 07680550600054

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Switzerland

Product Code National Health Reimbursement Number (NHRN) Timing Conclusion

Member
State Use Confirmation Overview Number of
In product Human
GTIN Other On Pack In UI system by Health human elements in
Code Readable
look-up Authority readable 2D barcode

NTIN (EAN 13)

with Regulation of
4 lines:
embedded TPA, Art. 17a
Switzerland Yes No No No No No GTIN or 4
Swissmedic is expected
NTIN
registration for 2019
number

Switzerland and Liechtenstein apply both the Swiss TPA. The new TPA Art. 17a allows Swiss Stakeholders to implement and use the same
security features as foreseen by the EU Delegate Regulation 2016/161 on a voluntary base.

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GTIN formation rules
GTIN Markets
Belgium Luxembourg* (Depending on country of origin)

Bulgaria Malta

Croatia Netherlands

Cyprus Poland

Czech Republic Portugal

Estonia Romania

Greece* Slovakia

Hungary Slovenia

Ireland UK

Italy Lithuania

Latvia

GTIN 14 = 0 + EAN 13

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GTIN formation rules

Padding EAN – 13 with ‘0’ in the front is leading to GTIN-14

3850114221627 Check Digit

EAN – 13 GS1 Country Code GS1 Company Code Item Code

GS1 Company Prefix

Packaging Indicator 03850114221627 Check Digit

Generating GTIN-14 from EAN – 13

GS1 Country Code GS1 Company Code Item Code

GS1 Company Prefix

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GTIN formation rules
• Countries which currently use EAN-13 code (13 digits) will build 14 digits GTIN by padding EAN-13
with “0“ in front of the code

GTIN 14 = 0 + EAN 13

Example:

EAN – 13 = 3850114202473

GTIN – 14 = 03850114202473

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Thank You

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