Questions about product packaging and identification of medicines

FAQs - Questions about product packaging and identification of medicines

The following abbreviations are recommended:

Abbreviation

Definition

Comment

GTIN

Global Trade Itrem Number

The "unique identifier" required by the EU includes the Product Code and the Serial Number.

In Switzerland, a GTIN is used to identify the Product.

EXP

Expiry Date

LOT

Lot/Batch Number

SN Serial Number

Beispielanordnung Barcodes Schweiz

Example: Pack with EAN-13 barcode and GS1 Datamatrix barcode with recommended Human Readable Interpretation (HRI) next to the 2D Barcode.

Basically yes, but for printing related reasons, this approach is not recommended as it can lead to shifts in the print output, which can lead to defective production. It is recommended to provide the corresponding abbreviations together with the Datamatrix code.

With regards to the submission to swissmedic for changes to the packaging materials, the status is as follows:

  • Swissmedic has expressed its intention to move away from the existing mechanisms and obligations for the submission of amendments requiring approval and reporting as part of the amendment of the regulations to the revised Medicinal Products Act, and to reintroduce the EU Regulation in Switzerland.
  • A finale statement by Swissmedic is still pending.
  • In the EU, the path is clear for EMA-approved products. However, the country-specific implementation of decentralized products does not appear to be quite uniform. CMDh, the Co-ordination Group for Mutual Recognition and Decentralized Procedure, is seeking pragmatic solutions.

No, EAN-13 is a symbology, a data carrier, or a scannable barcode that contains the GTIN as encoded information.

In the future, the EAN-13 will be replaced by a GS1 Datamatrix barcode, where the GTIN, Lot / BatchNumber, ExpiryDate and Serial Number can be encoded.

The Global Trade Item Number (GTIN) is a globally unique product number that is built according to the standards of the global GS1 organization. The GTIN is one of the EU-recognized product identification numbers, which serve as the basis for the unique identifier.

The number assignment is based on the Healthcare GTIN allocation rules. Further information on the GS1 system can be found at www.gs1.ch.

Yes. During a transitional period, this is also recommended to ensure that processes that do not yet support 2D barcodes continue to work.

The Swissmedic number must either be printed in human-readable form on the pack or printed in a 1D barcode with the 7680 prefix in a human-readable form.

Beispielanordnung Barcodes Schweiz

Example: Swissmedic Number with Prefix 7680 encoded in the EAN-13 barcode

Swissmedic Nummer Beispiel 2

Example: Swissmedic Number (stand alone)

No. A product must be clearly identifiable. Two different GTINs would lead to problems in all handling processes.

Beispielanordnung Barcodes Schweiz

Good Example: Identical GTIN or NTIN in the EAN-13 barcode and in the Datamatrix barcode

No. An NTIN is a valid identification number according to GS1 standards and does not necessarily have to be changed. Changing the NTIN to GTIN would have an impact on the supply chain processes and should only be done once the impact has been analyzed and it can be ensured that existing processes continue to run smoothly.

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