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.
GS1ID you can buy under With GS1.If you work in the pharmaceutical industry and need to serialize your medicines, we offer our members free of charge 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 GS1 DataMatrix containing GTIN, expiration date, batch/lot number and serial number.
Primary packaging In Denmark, Amgros requires that all medicines for oral use, all medicines for external use and all medicines for 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 marking the primary packaging must be either an EAN 13 barcode or a GS1 DataMatrix and must contain at least an NTIN or GTIN.
Download Amgro Primary Packaging Labeling Guide
The Nordic countries also have a number of overall recommendations for packaging labelling. Read more in this document
An NTIN is a 'Nordic Trade Item Number'.
It is constructed from a Nordic prefix (704626), which is not specific to the marketing proprietor or product, Vnr and a control digit. The Nordic article number (Vnr) is an identification code for a particular medicinal product with marketing authorisation in the Nordic countries. Vnr is a six-digit code (000001-199999 and 370000-599999). NTIN contains Vnr and changes only when Vnr changes. For example, NTIN does not separate packets of different languages or packets of different sizes. The NTIN is therefore not necessarily a unique identifier.
GTIN
A GTIN is a 'Global Trade Item Number' issued by GS1.
It consists of the prefix (GS1ID), issued by the GS1 organization in which the number was purchased, followed by the company's product number (the length of which depends on the length of one's prefix), as well as a check digit. Should a GTIN or NTIN be encoded in a EAN-13 barcode The number must be 13 digits. Should it be encoded in a GS1 Datamatrix, it should be 14 digits.
New NTINs will no longer be issued after February 9, 2019. Existing unique NTINs can be used as product codes, but use must follow GTIN rules.
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.
