In order to further strengthen the management and control of fentanyl substances and their precursors for pharmaceutical intermediates R&D, production and operation enterprises, and strictly prevent the occurrence of illegal and criminal activities in manufacturing, trafficking and smuggling, in accordance with relevant laws and policies, the relevant matters are hereby notified as follows:
1. Pharmaceutical intermediate companies and individuals shall abide by the "Drug Control Law of the People's Republic of China", "Shandong Province Drug Control Regulations" and other relevant laws, regulations and regulations. In the production and storage of chemical and pharmaceutical products, the name of the leased or transferee enterprise, the registration number of the business license, the personal information of the lessee or transferee, the lease period, the transfer time, and the main points of the lease or transfer of the production and business premises, facilities and equipment shall be truthfully recorded. Uses, etc., and report relevant information to the public security organ within five working days from the date of lease or transfer. Violations of the law will be investigated for legal responsibility in accordance with the law.
2. The construction project for the production of pharmaceutical intermediates shall undergo project approval and review, and be approved by the local administrative examination and approval bureau, and obtain the project registration documents before starting the construction of the project.
Pharmaceutical intermediate construction projects shall comply with the "Environmental Impact Assessment Law of the People's Republic of China" and other regulatory requirements, carry out the environmental impact assessment of the construction project before the official construction of the construction project, and obtain the environmental assessment approval and pollution discharge permit issued by the municipal ecological environment bureau.
The production of pharmaceutical intermediates shall obtain the "Industrial Product Production License" issued by the Ministry of Chemical Industry. If the involved products are hazardous chemicals, the "Hazardous Chemicals Production License" or the "Hazardous Chemicals Business License" shall be obtained at the same time. That is to say, the organization of production and operation will be handled in accordance with the State Economic Commission and other departments Jingzhi (1987) No. 180 "Provisions on Prohibition of Production and Sale of Unlicensed Products".
3. Pharmaceutical intermediate enterprises and individuals shall abide by the "Regulations on the Administration of Narcotic Drugs and Psychotropic Drugs", and "Measures for the Listing of Non-medicinal Narcotic Drugs and Psychotropic Drugs" and other relevant laws, regulations and regulations. Since May 1, 2019, the state has put the entire class of fentanyl substances under control. It should take the initiative to strengthen the publicity and education of the company and its employees, and it is strictly forbidden to develop, produce and operate the following 9 key fentanyl substances and their Precursor, violators will be held accountable in accordance with the law.
4. Pharmaceutical intermediate companies and individuals shall not privately publish the marketing information of fentanyl substances and their precursors or other precursor chemicals on the following 7 major international and domestic chemical website platforms. Violators will not only remove the marketing information, but also remove the marketing information. And will be held accountable in accordance with the law.
5. Pharmaceutical intermediate companies and individuals are strictly prohibited from selling the following fentanyl substances and their precursors to Myanmar, Mexico and other key countries and regions, or Yunnan, and offenders will be held accountable.
Fentanyl substances and 4-(N-phenylamino)piperidine dihydrochloride, 1-N-BOC-4-anilinopiperidine, 4-piperidone monohydrate hydrochloride, 4-piperidine Precursor materials such as pyridinediol hydrochloride, phenethylamine, methyl acrylate, aniline, and propionyl chloride.
6. Citizens are encouraged to report clues to illegal and criminal activities in the manufacture, trafficking and smuggling of fentanyl-like substances and their precursors that the public security organs have not yet discovered or grasped. If verified, the public security organs will award up to 300,000 yuan in rewards in accordance with relevant regulations.