Labeling

An update to approved product information (e.g., PI/SmPC/PIL) to reflect new evidence, usually requiring appropriate regulatory procedures (supplement/variation).

Testing to assess whether intended users understand key patient information and can use the product safely; often relevant for patient leaflets and device IFUs.

The iterative process of aligning final approved labeling language between applicant and regulator during late-stage review, based on evidence and risk communication needs.

A medication safety risk where product names/packaging look or sound similar, increasing the chance of selection or administration errors.

A preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in control of the healthcare professional, patient, or consumer.

FDA-approved patient labeling required for certain drugs with serious risks to help prevent harm and support appropriate use.

A draft representation of labels/cartons/leaflets used for regulatory review and approval, supporting packaging and artwork control processes.

In the US, the prescribing information (PI) that accompanies the drug and is intended for healthcare professionals. Contains full prescribing and safety information.

Version control and governance of labels/cartons/leaflets to ensure only approved content is printed and used, preventing mix-ups.

US rule that modernized the format and content requirements for prescription drug labeling, including Highlights and a table of contents.

The leaflet supplied with a medicinal product for the patient, written in lay language and based on the SmPC. Must be approved as part of the marketing authorisation.

US labeling intended for healthcare professionals describing safe and effective use (indications, dosing, contraindications, warnings, adverse reactions).

EU template and style guidance for product information (SmPC, labeling, and package leaflet) to ensure consistent structure and wording.

The legally approved document in the EU that describes a medicinal product for healthcare professionals: composition, therapeutic indications, dosing, contraindications, and safety information.

A standardized electronic format for US labeling content using structured XML to support exchange and display of labeling information.