Abstract
In this royal decree the responsibilities of the Spanish Agency for Medicines and Health Products, regional centers, health professionals and citizens and the obligations of the Marketing Authorization Holders (MAHs) are determined. All of them are designed to provide continuously the best information about drug safety, allowing the adoption of appropriate measures and ensure that the drugs available on the market present a favorable benefit-risk ratio for the population in the approved conditions of use. The responsibilities of the MAHs are covered in articles 8 through 14. In this review we are going to focus on these responsibilities.
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