Law No. 13 “On the circulation of medicines”.

This Law primarily addresses the legal regulation of medicines, establishing a comprehensive framework for their treatment, production, registration, and distribution. It aims to ensure the safety, efficacy, and quality of medicines, including narcotic and psychotropic substances, through a structured legal and policy approach. The Law emphasizes principles such as public health promotion, regulatory sustainability, domestic industry support, and transparency of information, operating within the broader context of national legislation, international treaties, and global standards like those of the World Health Organization and the International Council for Harmonization. Key measures include the development of a unified public policy on medicine quality and safety, the implementation of e-government systems for registration, surveillance, and traceability, and the regulation of pharmaceutical activities such as manufacturing, import, wholesale, retail, and clinical testing. The Law mandates the licensing of pharmaceutical entities, the recognition of international pharmacopoeias, and the registration and confirmation processes for medicines, including accelerated registration procedures for prequalified and internationally registered drugs. Medicinal plant materials shall be intended fresh or dried plants, algae, fungi or lichens or parts thereof, whole or crushed, used for the production and manufacture of medicines. The Law also stipulates the creation and maintenance of a State Register of Medicines, quality assessment protocols, and surveillance mechanisms like pharmacovigilance. Additionally, it specifies rules for advertising, storage, destruction, and import/export of medicines, along with procedures for handling unfit or falsified drugs. Implementation is structured through institutional responsibilities assigned to the Public Health Commissioner and other authorities, with timelines such as the enforcement of pharmaceutical practices by December 2030 and traceability requirements by December 2025. The Law details procedural aspects including licensing, registration, inspection, and enforcement measures, emphasizing transparency, stakeholder participation, and compliance monitoring. It also delineates penalties for violations and provides transitional provisions to ensure phased adoption of new regulations, with the law entering into force upon official publication.