In the regulatory context, labeling refers to all textual information accompanying a medicinal product. This includes not only the label on the primary and secondary packaging, but primarily the Summary of Product Characteristics (SmPC) and the Package Leaflet (PL) for the patient. The contents of the labeling are approved by health authorities as part of the marketing authorization process and must comply with strict regulations.
The SmPC is intended for healthcare professionals and contains all essential information for the safe and effective use of the medicinal product. The Package Leaflet is written in lay language. The correct labeling of investigational medicinal products in clinical trials is also strictly regulated (e.g., in EU GMP Annex 13) to ensure participant safety and study integrity. For CROs, the preparation and review of these documents is an important task in the areas of Regulatory Affairs and Medical Writing.