Transition from NTIN to GTIN

Important documents:
The serialisation of Nordic packages, country specific requirements 14.6.2024 (pdf)
Linkage between Vnrs and GTINs in the Nordic countries (pdf)
DMVO: 2D data matrix in Denmark (pdf)

Identifiers on primary packages (human medicines):
Primary package identifiers_Guidance for pharma companies (pdf)
Primary package identifiers_summary OnePager (pdf)
Q&A primary packages (pdf)


CHANGE SITUATIONS VNR vs. GTIN

General rule: If the Vnr changes, the GTIN always changes!
A new GTIN is also required as per the table below:

Change VNR GTIN
Composition of the article: active ingredient New Vnr required New GTIN required
Composition of the article: excipient Same Vnr * New GTIN required
Trade name New Vnr required * New GTIN required
Marketing authorisation holder (MAH) New Vnr required * New GTIN required **
Marketer Same Vnr New GTIN required **
Pharmaceutical dosage form New Vnr required New GTIN required
Strength New Vnr required New GTIN required
Pack size (net content) (pcs, g…) New Vnr required New GTIN required
Primary package type New Vnr required * New GTIN required
Secondary package type Same Vnr Same GTIN
Rx → OTC New Vnr required * New GTIN required
OTC → RX Same Vnr New GTIN required
PIL (se + dk) → PIL (se + no) Same Vnr New GTIN required
Adding languages on PIL with no need to separate from old version Same Vnr Same GTIN
Package size (length x width x height) < 20 % Same Vnr Same GTIN
Package size (length x width x height) > 20 % Same Vnr New GTIN required
Additional pallet layout Same Vnr Same GTIN***
Manufacturing site Same Vnr Same GTIN
Wholesaler Same Vnr Same GTIN
Shelf life Same Vnr New GTIN required #
Storage conditions Same Vnr New GTIN required #
Market (adding language on the package) – no need to separate from old version Same Vnr Same GTIN
Market (adding language on the package) – need to separate from old version Same Vnr New GTIN required
Market (removing language on the package) Same Vnr New GTIN required
Colour on package Same Vnr Same GTIN
Change of originating country for parallel imported products Same Vnr New GTIN required
Kits (packages containing devices): change of package content Same Vnr New GTIN required
Kits (packages containing devices): adding/removing content Same Vnr New GTIN required
Kits (packages containing devices): substituting component(s) with GTIN(s) Same Vnr New GTIN required
Kits (packages containing devices): substituting component(s) without GTIN(s) Same Vnr Same GTIN
* Please see wiki.vnr.fi / changes in Vnr information
** Depends on the GS1 prefix owner
*** New GTIN required for pallet
# GTIN has to be changed if the change affects at least one actor in the supply chain

FOR MORE INFORMATION REGARDING GTINs:
GS1 GTIN Allocation Rules
Short guidance to using GTINs (pdf)
GTIN NTIN VNR_Coding of medicines_Prepare and act now (pdf)

FI:
Siirtyminen GTIN-koodeihin Pikaohje (pdf)

If you need more information regarding GTINs and the eVerification, please contact:

GTINs eVerification contact homepage
Denmark www.gs1.dk info@dmvo.dk www.dmvo.dk
Finland www.gs1.fi info@laakevarmennus.fi www.laakevarmennus.fi
Iceland www.gs1.is hjorleifur@lyfjaaudkenni.is https://lyfjaaudkenni.is/en/icemvo/
Norway www.gs1.no post@nomvec.no www.nomvec.no
Sweden www.gs1.se info@e-vis.se www.e-vis.se

GTIN (Global Trade Item Number)
The Global Trade Item Number™ (GTIN™) is used for the unique identification of trade items worldwide.
Usually 13 characters long, consisting of a country and a company prefix, the company’s own item reference and a check digit.  The digits can be shown as barcodes or be written on a RFID chip enabling an automatic and faultless identification. The numbering is carried out by the company responsible for the product launch.

NTIN (National Trade Item Number)
NTIN is a GTIN, which prefix is owned by the Nordic Vnr administrator.
(Nordic prefix regardless of the MAH).
NTIN contains the Vnr and is only changed when the Vnr is changed. NTIN does not separate, for example, packages with PLs in different languages or packages with different measurements. NTIN is therefore not necessarily a unique identifier.
If all packages with a common Vnr aren’t identical, GTIN codes must be used for identifying the packages. One Vnr can then have many different GTINs.
(for more information about barcodes, see Product codes)