Drug labeling is the application of information and unique identification codes to the packaging of drugs. The purpose of drug labeling is to ensure the quality and safe use of drugs, prevent counterfeit products and improve their traceability throughout their life cycle, from manufacture to use by the patient. An important component of labeling (German translation: Kennzeichnung) the use of automatic identification technologies such as barcodes and QR codes, such as those used in the German securPharm system.

The key elements of drug labeling include:

• Drug name: Of course, each package of a drug must most importantly have the name of the drug on it, as well as the active pharmaceutical ingredient (or ingredients), the strength and the dosage form.
• Batch number and expiration date: The labeling also contains information on the expiration date of the drug and the batch number (translation into German: Chargenbezeichnung). This information is important for ensuring patient safety and preventing the use of expired products.
• Manufacturer information: The labeling includes information about the manufacturer (German: Hersteller) or the pharmaceutical company that manufactured the product. This allows for traceability and clearly defines the responsible party in case any problems with the product arise.
• Barcodes and QR codes: Barcodes and QR codes are important labeling elements that facilitate the automatic scanning and identification of products during sale, delivery and use.
• Safety features: Special features such as specific visible and invisible labels, holographic seals and other technologies can be used to protect against product counterfeiting.

Drug labeling is a mandatory and important task of the pharmaceutical industry, the requirements of which can vary depending on the laws and regulations of the individual countries. In Germany, Section 10 of the German Medicinal Products Act applies, but there are also EU directives (German translation: EU-Richtlinien) that must be complied with. Correct and complete drug labeling helps to ensure drug safety and protect the interests of patients by providing information transparently.

Contact our pharmaceutical interpreters and GMP translators if you would like to leave the language support for your GMP inspection to professionals. We also prepare pharmaceutical translations for your company (SOPs, inspection reports, SMF, etc.). Moreover, we offer consultancy services in the run-up to GMP inspections, representation of international pharmaceutical companies and distribution of their products in Germany.