Regional Drug Labeling, Health Professional Labeling

Product labeling is designed to serve multiple functions across several regions and countries. On a basic level, national and regional health professional (HP) and patient and consumer labeling communicates information pertaining to 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 HP labeling to find out whether they could expect a suspected adverse drug reaction for purposes of expedited reporting to local Regulatory authorities. The exact labeling content of national and regional Drug labeling is generally negotiated between biopharmaceutical companies and Regulatory authorities.

While a lot of countries/ and regions offer a two-tiered labeling system with patient and /consumer information as well as HP labeling, Canada offers a three-tiered system with some detailed scientific information beyond what is included in the “regular” HP labeling.