Laser coding and marking solutions for pharmaceuticals
The labeling requirements for patient protection are particularly strict for medicinal products. All packaging has to carry certain information for traceability and forgery-proofing. Our laser marking systems ensure standard-compliant pharmaceutical labeling.
Prescription drugs: Clear labeling rules
LASER CODING AND MARKING SOLUTIONS FOR THE PHARMACEUTICAL INDUSTRY
Uniform regulations apply in the EU for the forgery-proof marking and complete traceability of prescription drugs and medicines. These protect customers and the pharmaceutical industry alike from product piracy. This is because the prescribed codes and markings ensure that only unopened medicines in their original packaging are dispensed or administered in pharmacies and hospitals. Directive 2011/62/EU requires the individual marking of medicinal products, which is achieved through the serialization of pharmaceutical packaging.
According to the Falsified Medicines Directive 2011/62/EU ("Falsified Medicines Directive" for short), three elements are required: a machine-readable 2D Matrix code that serves as a unique identifier, the additional plain text printing of certain product information from the code and a seal on the pharmaceutical packaging as first-opening protection. The contents of the 2D Matrix code are clearly defined: Product code to identify the medicine, serial number, national reimbursement or identification number, batch number of the medicine and its expiry date. The combination of variable data in the 2D Matrix code (QR code) and the repetition of some information in plain text (product code, serial number, reimbursement number) ensure forgery-proofing. Before dispensing medicines, pharmacies have to scan the QR code. The serial number and product code are automatically compared with a manufacturer database. If the serial number is not registered in the database or has already been booked out, a counterfeit alarm is automatically triggered and the medicine may not be sold.
What is important for laser coding and marking solutions?
- Legal requirements in accordance with Directive 2011/62/EU
- Error-free serialization
- Machine-readable QR code
- Fast, simple and economical coding and marking technologies
- Permanent and durable marking
- Often a lot of information on a small area
Industrial laser coding and marking solutions are used throughout the pharmaceutical industry. A wide variety of primary and secondary packaging is marked with codes and variable data. They support the identification, tracking and management of pharmaceutical products throughout the entire production and distribution cycle.
Application examples for pharmaceutical markings
- Laser marking of folding boxes and secondary packaging
- Blister or blister packaging coding
- Direct marking of closure caps
- Printing of QR code, pharmaceutical central number (PZN) and pharmaceutical product number (PPN)
- Serialization of prescription drugs
Since 2019, prescription-only medicinal products in the European Union have to be provided with a unique identifier and a device to detect possible tampering in accordance with Directive 2011/62/EU in conjunction with Delegated Regulation (EU) 2016/161. This protects consumers and manufacturers from counterfeit medicinal products.