Linkage information between up to date product codes (GTINs, unique NTINs) and Vnrs is essential for the correct handling of the packs at pharmacies, hospital pharmacies and wholesalers with or without FMD verification. For more information regarding the linkage in the different Nordic countries, please see separate document here
There can be different data carriers on a medicinal package.
GS1 Data matrix is a machine-readable, 2-dimensional data carrier. On medicinal packages, due to the Falsified Medicines Directive, it must contain the following information
- product code, GTIN or unique NTIN (PC=product code)
- unique serial number (SN=serial number)
- batch number (LOT=XXX)
- expiring date (EXP=XXX)
The information above has to be on the package in a human readable format also.
It is also possible to enter additional information to the GS1 Data matrix, besides the information required for the eVerification.
The QR code and the GS1 Data matrix look similar but can be separated by the fact that the QR code have darker squares in three corners.
The QR code can be scanned by the user with a smart phone and can, for example, contain a web address providing medical information. The QR code is not related to the eVerification or FMD in any way.
In addition to the GS1 Data matrix (and the QR code) the package can still contain a traditional, linear bar code carrier, such as EAN-13. Important: the product code in the linear bar code must be the same as in the GS1 Data matrix. A linear bar code is no longer needed when a GS1 Data matrix has been introduced on the package.
Format of the product code
The European directive on falsified medicines prescribes mandatory, harmonized safety features on all prescription pharmaceuticals. These safety features consist of a unique package identity combined with tamper evidence.
Only GTINs or unique NTINs can be used as product codes for pharmaceuticals in the Nordic countries, within the scope of FMD or not.
A GTIN-13 consists of 13 digits on the format:
Company prefix + article reference number + check digit
Check digit calculated in accordance with a GS1 algorithm
In order to place a 13-digit product code (GTIN or unique NTIN) in a GS1 Data matrix an additional 0 must be adder in the beginning of the code to make it 14-digits long.
For more information regarding GTINs, please see the local GS1 webpages
An NTIN is a GTIN, but with a fixed prefix and a Vnr instead of an article reference number.
Prefix of Nordic Number Centre (704626) + Vnr + check digit
- 704626 is the prefix of NNC used as a common Nordic company prefix for pharmaceuticals.
- Since NTIN contains the Vnr, there can be only one NTIN per Vnr. The product code will thereby be the same for all packages with the same Vnr. An NTIN identifies a unique package only if the article has identical packages. Packages with common Vnrs, but differences in the packages (e.g. PIL), should be separated with different GTINs.
New NTINs are not issued any more after 9.2.2019. Existing unique NTINs can be used as product codes, but the use must follow the GTIN rules.