Marketing Authorization Application (MAA)

A Marketing Authorization Application (MAA) is a formal request submitted to a regulatory authority, such as the European Medicines Agency, to approve a new medicine or vaccine for public use. It includes detailed information about the product’s safety, effectiveness, manufacturing quality, and how it’s used. The goal is to ensure the medication is safe and effective for patients before it can be sold and distributed. Once approved, the medicine can be marketed in the region, allowing healthcare providers to prescribe it. The MAA process is a critical step in bringing new therapies to patients in a safe and regulated manner.