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)