Overview
Product labeling is designed to serve multiple functions across several regions and countries and catering their regional product labeling requirements. On a basic level, national and regional Health Professionals (HP), patients, and consumers rely on the regional label information for the benefits and risks of the product. It also offers advice on the effective and safe use of the same product. Biopharmaceutical companies take advantage of the national/regional product labeling to find out whether they could expect a suspected adverse drug reaction for purposes of expedited reporting to the local Regulatory Authorities. The exact labeling content of national and regional product labeling is generally negotiated between biopharmaceutical companies and Regulatory Authorities. At the same time, it would benefit organizations if they were to achieve core-to-local label harmonization, saving time while aligning with regional label-specific requirements. Regional label safety alignment must also be ensured with the reference label.
While a lot of countries and regions offer a two (02)-tiered labeling system with the patient and consumer information as well as HP labeling, Canada offers a three (03)-tiered system with some detailed scientific information beyond what is included in the “regular” HP labeling.
To streamline end-to-end Regulatory labeling practice from creation to tracking to managing in company of any size, Freyr offers a centralized labeling life cycle management software, Freyr LABEL. Right from creating, tracking and managing company core data sheet (CCDS) deviations, CCDS updates, and developments to creating, implementing, and inspecting multi-lingual regional labels as well as custom reporting. Freyr LABEL puts companies in total control of all their Regulatory labeling compliance needs.
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