Counterfeiting in the pharmaceutical sector is assuming more extensive and serious proportions. Many countries and currently also the EU are reacting to this with tightened regulations to protect against the counterfeiting of medications. Trust in our expertise and prevent high investments in systems and IT.
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
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).
Pharmaceutical manufacturers now have three years to implement all necessary measures for labelling their packaging and for checking and securing the associated processes.
COMPLEX REQUIREMENTS - WE SET FOR YOU
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 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 uses DOD-Technology with UV drying to enable you to obtain all types of codes at the highest quality level (Grading B).
Chinese veterinary QR code
An additional current directive in veterinary medicine in China stipulates a serialised QR code effective from the end of June 2016. In addition to the serial number this contains the product name, a registration number, the manufacturer and a telephone number for emergencies. We have equipped our machines and systems for folding cartons and adhesive labels and can offer you this code at the highest quality level.
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 advise you on this complex subject area.