NMPA issues narcotic, psychotropic drug trade rules

The agency revised its requirements from 2016.

China's National Medical Products Association (NMPA) released the Narcotic Drugs and Psychotropic Drugs Import and Export Permits Application Documents Requirements.

According to the new requirements, relevant companies must submit an anaesthetic (psychiatric) drug export application form, a copy of the contract or order, the original import permit issued by the importing country or region anaesthesia (psychiatric) drug regulatory agency, the corresponding drug registration certificate or chemical raw material drug approval notice copy, Business License and Foreign Trade Operator Record Registration Form copy, self-assurance statement on the authenticity of the application materials, and more.

Compared with the 2016 requirements, the document adds more specific requirements. Companies with no Registration Form for Foreign Trade Manager can provide a Certificate of Approval for Establishment of Enterprises with Investment of Taiwan, Hong Kong, Macao and Overseas Chinese in the People's Republic of China, or the Certificate of Approval for Establishment of Enterprises with Foreign Investment in the People's Republic of China.

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