The medicinal products enter on the market after fulfilling several requirements. The drugs enter on the market after assessing their efficacy, safety and quality and after its having a price and determination of their value, If holders wish that medicines are funded third payers

The marketing authorization is given by regulators in most countries. In Europe, they are the European Medicines Agency and the regulatory authorities in each country.

The rules for the first phases are defined in the European Union at the European level. The remaining requirements are the internal competence of each country.