Adverse Event/Side Effect/Product Quality Reporting


Adverse effect/Side effect is a response to a drug which is noxious and unintended, and which occurs at doses normally used in human being for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function. Product quality issues are any abnormalities that may be introduced during the manufacturing/labelling, packaging, shipping, handling or storage of the products. They may occur with or without clinical consequences.