Comprehensive Study on Labelling Requirements for Pharmaceutical Drugs (Human Use) With Impact of Post Noc Changes Including Labelling Query Management Health Canada

Abstract

Labelling plays an important role of communicating information regarding the drug product, hence, it has to be in plain language and should contain the actual information to avoid the health hazards of the consumers. Health Canada has specific labelling requirements for the drug product. The study contains the information regarding general and detailed labelling requirements for the pharmaceutical products. There are special requirements for labelling for different product types such as insulin preparations, parenteral products, schedule C drugs, professional use products,…etc. Also the work contains the requirements of good label and package practices for prescription and non-prescription drug products. Also, the study contains the Post NOC changes related to the quality, safety and efficacy of rug product and its impact on label. There are examples of labelling queries with the solution to better understand the Heath Canada’s expectations.