Real Decreto 1345/2007, de 11 de octubre, por el que se regula el procedimiento de autorización, registro y condiciones de dispensación de los medicamentos de uso humano fabricados industrialmente

This Royal Decree establishes the procedures for authorizing, registering, and dispensing industrially manufactured human medicines in Spain. It aims to ensure the safety, quality, and efficacy of these medications available to the public. The regulation affects pharmaceutical companies, healthcare professionals, and patients by setting standards for medicine approval and distribution, impacting access to treatments.