Serialisation:
for pharma packaging

CODES TO COMBAT COUNTERFEIT MEDICATION

Today the complexity of serialisation is evident. In the case of folding cartons the packaging material, encoding technology used, individual settings of the print head or laser, operating speed of the packaging line and many more factors come together. The quality and consequently the legibility of the code are also significant in the end. The EU decree stipulates a print quality of at least 1.5 in line with the ISO/IEC 15415:2011 standard, which corresponds to the so-called Grading C.

In addition to the regulations for identification and authentication of pharmaceutical packaging valid in the EU as of 9.2.2019, there are also different code variations in other countries such as Russia, China, Turkey or Brazil, which have to a large extent already put their respective legal stipulations in place. The USA has gone one step further and as of the end of 2017 will require serialisation as well as complete traceability of the medication by 2023 (Track & Trace).

A significantly higher level of legibility is required particularly in the case of the so-called China Code, a 1D-Barcode 128C. Faller Packaging uses DOD-Technology with UV drying to enable you to obtain all types of codes at the highest quality level (up to Grading A).

EU: Delegated Regulation (EU) 2016/161

The delegated directive (EU) 2016/161 from the EU commission “foresees a system whereby the identification and determination of the authenticity of medication is guaranteed by an end-to-end-check of all medication that bears the safety features.”

The stipulated feature is a 2D-Data-Matrix Code, which contains the following information:

  • Product codes for the identification of medication (name, common designation, dosage form, strength, size of package and type of packaging of the medication)
  • Serial number (numeric or alphanumeric sequence with a maximum of 20 characters)
  • National reimbursement number or another national number for identification of the medication
  • Batch number
  • Expiry date

The product code, serial number and the national reimbursement number should also be displayed on the packaging in a format that can be read by humans (plain text).

Since February 2019, pharmaceutical manufacturers have had to implement everything necessary to label packaging and to test and secure the associated processes.

Talk to us, we will be happy to consult you!

Russia: Russian Government decree No 1556

From 1 January 2020, suppliers of pharmaceutical products will be required by law to put crypto codes on their products for the Russian market. The purpose is to ensure better traceability and reliable protection against counterfeiting.

The crypto codes required by Russian law for identification, verification and tracking of pharmaceuticals and other products can have a data density of up to 44 x 44 modules. The data quantity is much greater than with the serialisation stipulated by EU countries. Manufacturers are thus faced with the difficult task of printing more data in a similar area while maintaining consistently high quality.

In addition to the GTIN and a serial number, the new codes include a verification part consisting of a verification key and a digital signature. The verification part with its crypto key is designed to make product counterfeiting much more difficult.

We are well prepared for these requirements and look forward to your inquiry.

China: 128C bar code

As of 2015, all pharmaceuticals sold in China must now bear the following serialisation.

The so-called China Code for human drugs consists of a twenty-digit 128C bar code containing a 6-digit product code, a 9-digit serial number, a 4-digit verification number and the aggregation level of the logistics element to be coded.

All logistics units (bundle, cardboard outer packaging, pallet) are marked and traced throughout the supply chain (aggregation). The patient is responsible for checking the dispensed pack. They can read the code via an app on their smartphone or enter the twenty-digit number on a website to check the origin and authenticity of the product.

We support you with the implementation, please contact us!

Serial coding of Labels

The seemingly endless selection of materials makes the total requirements within serialisation even more difficult to implement when coding adhesive labels.

The use of different material types and combinations, the varied code procedures available and, of course, the technological setting of the machines all make the ideal choice of material and system individual and demanding.

We have gained a great deal of experience in this field and would be happy to consult you on this complex subject area.

Serial coding at Faller Packaging

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