The pharmaceutical industry and manufacturers of pharmaceutical products are subject to the strictest marking regulations. In the European Union, the Falsified Medicines Directive 2011/62/EU and Delegated Regulation (EU) delVO 2016/161 regulate which medicines and medicinal products have to be marked and how. This stipulates the serialization requirement for prescription-only medicines and tamper-proof packaging. For this purpose, the pharmaceutical packaging is provided with a unique identifier in the form of a 2D-Matrix-Codes, the information integrated there is also printed in plain text and an additional seal is applied. These measures help to make pharmaceutical products forgery-proof and enable their complete traceability along the entire production and supply chain back to the manufacturer. They thus perform an important contribution to patient protection.
Challenges in marking for the pharmaceutical industry
- Different forms of packaging and secondary packaging
- Very strict normative labeling requirements (Directive 2011/62/EU)
- Ensuring optimal readability and contrast on a permanent basis
- Proof of initial opening of packaging
- Ensuring forgery-proof packaging
- Serialization / Track & Trace
- A lot of information on sometimes very small areas
