<![CDATA[Legal protection of children against the risks of unsafe medicines is an essential component of fulfilling children's rights to health and safety in pharmaceutical services. This study aims to analyze the legal protection afforded to pediatric patients under Minister of Health Regulation Number 72 of 2016, identify normative gaps in its provisions, and formulate a legal protection framework guided by the best interests of the child. This study employs normative legal research using statutory and conceptual approaches. Primary and secondary legal materials are analyzed qualitatively through legal interpretation and content analysis. The findings indicate that Minister of Health Regulation Number 72 of 2016 provides a normative foundation for patient protection through provisions governing pharmaceutical supply management and clinical pharmacy services. However, the regulation does not explicitly and systematically integrate child protection principles, particularly regarding the best interests of the child, the specific needs of pediatric patients, children's rights to information and participation, risk-based supervision, and accountability. This study develops a three-layer legal protection model comprising preventive protection to minimize risks, responsive protection to address threats to patient safety, and corrective protection to restore rights and improve systems following harm. The study concludes that strengthening legal protection requires integrating child protection principles into pharmaceutical service standards, supported by regulatory harmonization and institutional coordination to establish a sustainable protection system]]>
