GTIN
Colloquially, many know GTIN as a barcode, but technically, GTIN is the number found beneath the barcode symbol itself, and can therefore also be used for other technologies such as 2D barcodes and RFID tags.
Colloquially, many know GTIN as a barcode, but technically, GTIN is the number found beneath the barcode symbol itself, and can therefore also be used for other technologies such as 2D barcodes and RFID tags.
To prevent counterfeit medicines from entering the supply chain, pharmaceutical manufacturers are required to label prescription medicines with a 2D DataMatrix containing a unique product number, serial number, batch/lot number, and expiry date.
GS1 provides guidance on how pharmaceutical manufacturers can meet regulatory requirements in the barcode - for example, how to generate a unique product number using a GS1ID and which product changes require a change to the product’s globally unique identification number (GTIN).
GS1 ensures the traceability of medicines throughout the entire supply chain - from the manufacturer, to the distributor, and ultimately to the patient.
Watch this short animation about a vaccine’s journey from factory to patient, and see how it is ensured that the right patient receives the right vaccine.
EU law requires prescription medicines sold to the European market to be labelled with a barcode containing the product identification, expiry date, batch/lot number and serial number.
Download the EU Regulation on Serialization (in English)
For unique product identification, a GS1ID to form a Global Trade Item Number (GTIN) for each product. The product's GTIN, as well as the expiration date, batch/lot number and serial number are encoded in a GS1 DataMatrix which is a 2D matrix barcode of ISO version ECC 200). The data matrix is used worldwide and is intended to be applied to prescription drugs.
You can buy GS1ID in My GS1. If you work in the pharmaceutical industry and need to serialize your medicinal products, we offer our members free advice and courses
Secondary packaging
For medicinal products produced on or after 9 February 2019, it is a requirement that the secondary packaging be marked with a GS1 DataMatrix containing GTIN, expiration date, batch/lot number and serial number.
Primary packaging
In Denmark, Amgros requires that all medicines for oral use, external use as well as injection and infusion must be labelled with a barcode on the primary packaging. However, the requirement does not apply to tablets or capsules in blister sheets or other similar packaging in which the tablets/capsules are individually distributed. Read more about barcode requirements
The barcode used for labeling the primary packaging must be either an EAN-13 barcode or a GS1 DataMatrix and must contain at least a GTIN.
Download Amgros's guidance on the labelling of primary packaging
See the Nordic countries' recommendations for packaging labelling
GTIN
GTIN (Global Trade Item Number) is used for product identification and the exchange of product data across the supply chain.
It consists of the prefix (GS1ID) issued by the GS1 organization from which the number was purchased, followed by the company's product number (the length of which depends on the length of the prefix), and a check digit.
If a GTIN is to be encoded in an EAN-13 barcode, the number must consist of 13 digits. If it is to be encoded in a GS1 DataMatrix, it must consist of 14 digits.
NTIN
NTIN (Nordic Trade Item Number) was previously used to identify medicinal products in the Nordic region.
New NTINs are no longer issued, but existing unique NTINs may continue to be used provided they comply with GS1 rules for GTINs.
If you have questions about how to use our GS1 standards, you can receive help and guidance every day.
We are ready to guide you smoothly through the process.
