A drug cannot be sold without permission. Marketing authorization is the official approval from a regulatory body that allows a company to market a medicine in a specific jurisdiction. In the European Union, the EMA evaluates the application and the European Commission grants the authorization. In the United States, the FDA grants approval through a new drug application or biologics license application. In other countries, national regulators issue their own authorizations, sometimes relying on decisions from larger agencies.

The authorization specifies the conditions of use. It defines the approved indication, the dose, the route of administration, the patient population, and the warnings. It also specifies the labeling, which must be approved. The company must comply with post-marketing obligations, including safety reporting and any required studies. Marketing authorization is not permanent. It can be suspended or revoked if new safety concerns emerge or if the company fails to meet its obligations. Variations to the authorization are required for changes to the manufacturing process, the labeling, or the approved indication.

What authorization covers:

• Indication. The specific disease or condition the drug is approved to treat.
• Population. Which patients can receive it.
• Dose and route. How much and how it is given.
• Labeling. The approved prescribing information.
• Post-marketing obligations. Safety reporting and additional studies.

Off-label use, prescribing a drug for an indication not covered by the authorization, is legal in many countries but carries additional risks and responsibilities for the prescriber.