What does the term "marketing authorization" refer to?

The term "marketing authorization" specifically refers to the approval granted by regulatory authorities that allows a company to market a pharmaceutical product. This approval is a crucial step in the drug development process, indicating that the product has been evaluated for safety, efficacy, and quality based on the data submitted by the manufacturer. Only after obtaining this authorization can a company legally sell the product to consumers.

This process ensures that the product meets established standards and regulations before it reaches the market, thereby safeguarding public health. It is distinct from the permission to conduct clinical trials, which is a preliminary step that occurs before marketing authorization is sought. Additionally, while safety certification is important, it doesn’t encompass the full scope of what marketing authorization entails, which also includes efficacy and quality assessments. Finally, the issuance of patents is unrelated to marketing authorization, as patents deal with intellectual property rights rather than the approval required to sell a product.