Designation of Shitei Yakubutsu (designated substances), based on the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (hereinafter referred to as the Act). (1960, Law No.145); (1 page(s), in English)
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แจ้งเวียนกฎระเบียบอื่น ๆ

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Implementing Guidelines on the Registration of Chemical Pharmaceutical Products for Human Use Applied for Marketing Authorization in accordance with Administrative Order No. 2024- 0013 "General Rules and Regulations on the Registration of Pharmaceutical Products and Active Pharmaceutical Ingredients Intended for Human Use"; (100 page(s), in English)
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DMS 2086:2024, Polyethylene terephthalate (PET) bottles for packaging edible oils – Specification ; (3 page(s), in English)
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NTON 19001:2022 Requisitos para la Autorización de Ensayos Clínicos de Medicamentos en Seres Humanos (Nicaraguan Mandatory Technical Standard (NTON) No. 19001:2022 Requirements for the authorization of clinical trials of medicines on humans) (83 pages, in Spanish)