Pharmaceutical intermediates research and development, production and management companies should understand those things
Release time:
2019-07-05
In order to further strengthen the control of fentanyl substances and their precursors in pharmaceutical intermediates R&D, production and operation enterprises, and strictly prevent illegal and criminal activities of manufacturing, trafficking and smuggling, in accordance with relevant laws and policies, the relevant matters are hereby informed as follows:1. Pharmaceutical intermediates enterprises and individuals shall comply with relevant laws, regulations and regulations such as the Drug Control Law of the People's Republic of China and the Drug Control Regulations of Shandong Province. If facilities and equipment such as production and operation sites and reactors are leased or transferred to others for the production and storage of chemical and pharmaceutical products, the name and business license registration number of the leased or transferred enterprise shall be truthfully recorded. Lessee or transferee personal information, lease term, transfer time, lease or transfer of production and business sites, facilities and equipment, the main use of information, and from the date of lease or transfer to five working days to report to the public security organs related information, illegal will be investigated for legal responsibility.
Second, the construction project of the production of pharmaceutical intermediates shall go through the project approval review, the approval of the local administrative examination and approval bureau, and obtain the project filing document before carrying out the project construction work.
Pharmaceutical intermediates construction projects shall comply with the requirements of the Environmental Impact Assessment Law of the People's Republic of China and other regulations, carry out the environmental impact assessment of the construction project before the formal construction of the construction project, and obtain the environmental assessment approval and emission permit issued by the municipal ecological Environment Bureau.
The production of pharmaceutical intermediates shall obtain the Production License of Industrial Products issued by the Ministry of Chemical Industry. If the products involved are hazardous chemicals, the Production License of Hazardous Chemicals or the Operation License of hazardous Chemicals shall be obtained at the same time. Without the organization of production, business will be in accordance with the State Economic Commission and other departments of the economic quality (1987)180 document "Strictly prohibit the production and sale of unlicensed products" treatment.
3. Pharmaceutical intermediates enterprises and individuals shall comply with relevant laws, regulations and provisions such as the Regulations on the Administration of Narcotic Drugs and Psychotropic Drugs and the Measures for the Listing and Control of Non-Pharmaceutical Narcotic Drugs and Psychotropic Drugs. Since May 1, 2019, the state has listed the entire class of fentanyl substances, should take the initiative to strengthen the publicity and education of the company and its employees, and prohibit the unauthorized research and development, production and operation of the following nine key fentanyl substances and their precursors, violators will be investigated for legal responsibility.
Pharmaceutical intermediates enterprises and individuals shall not privately publish fentanyl substances and their precursors or other precursor chemicals marketing information in the following seven major international and domestic chemical website platforms, violators will not only be cleaned up and deleted marketing information and will be investigated for legal responsibility.
Pharmaceutical intermediates enterprises and individuals are strictly prohibited from selling the following fentanyl-like substances and their precursors to key countries and regions such as Myanmar, Mexico or Yunnan, and violators will be investigated for legal responsibility.
Fentanyl substances and precursors such as 4- (n-phenylamino) piperidine dihydrochloride, 1-N-BOC-4-aniline-piperidine, 4-piperidone monohydrate hydrochloride, 4-piperidine dihydrochloride, phenethylamine, methyl acrylate, aniline, propionyl chloride, etc.
6. Citizens are encouraged to report clues of illegal and criminal activities related to the production, trafficking and smuggling of fentanyl-like substances and their precursors that have not been discovered or obtained by the public security organs. If they are verified, the public security organs will give a reward of up to 300,000 yuan in accordance with relevant regulations.
Original title: "Anti-drug Law (4) | Pharmaceutical intermediates research and development, production and management enterprises should know those things"
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