In order to further strengthen the control of fentanyl substances and their precursors in pharmaceutical intermediate R & D, production and operation enterprises, and strictly prevent the occurrence of illegal and criminal activities of manufacturing, trafficking and smuggling, in accordance with relevant laws and policies, the relevant matters are hereby notified as follows:
1. pharmaceutical intermediate enterprises and individuals shall abide by the the People's Republic of China Drug Control Law, Shandong Drug Control Regulations and other relevant laws, regulations and regulations. If the production and operation sites, reactors and other facilities and equipment are leased or transferred to others for the production and storage of chemical and pharmaceutical products, the name of the leased or transferred enterprise, the registration number of the business license, the personal information of the lessee or transferee, the lease period and the transfer time shall be truthfully recorded, leasing or transferring the main use of production and business premises, facilities and equipment, etc., and reporting 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.
The construction project of the 2. production of pharmaceutical intermediates shall be subject to the examination and approval of the local administrative examination and approval bureau, and the project filing documents shall be obtained before the construction of the project can be carried out.
Pharmaceutical intermediate construction projects shall comply with the "the People's Republic of China Environmental Impact Assessment Law" and other regulatory requirements, carry out environmental impact assessment of construction projects before the formal construction of construction projects, 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 product involved is a hazardous chemical, it shall obtain the "Hazardous Chemical Production License" or "Hazardous Chemical Business License" at the same time. The organization of production and operation will be handled in accordance with the provisions of the Economic Quality (1987) No. 180 of the State Economic Commission and other departments.
3. pharmaceutical intermediate enterprises and individuals shall abide by the regulations on the administration of narcotic drugs and psychotropic substances, the measures for the administration of non medicinal narcotic drugs and psychotropic substances and other relevant laws, regulations and provisions. Since May 1, 2019, the state has listed and controlled the whole class of fentanyl substances. It should take the initiative to strengthen the publicity and education of the company and its employees. It is strictly forbidden to develop, produce and operate the following nine key fentanyl substances and their precursors without authorization. Violators will be investigated for legal responsibility according to law.
4. pharmaceutical intermediate enterprises and individuals are not allowed to privately publish marketing information of fentanyl substances and their precursors or other precursor chemicals on the following seven major international and domestic chemical website platforms. Violators will not only delete the marketing information but also be investigated for legal responsibility according to law.
5. pharmaceutical intermediate enterprises and individuals, it is strictly forbidden to sell the following fentanyl substances and their precursors to key countries and regions such as Myanmar, Mexico or Yunnan. Violators will be investigated for legal responsibility.
Fentanyl substances and 4-(N-phenyl amino) piperidine dihydrochloride, 1-N-BOC-4-anilino piperidine, 4-piperidone monohydrate hydrochloride, 4-piperidinediol hydrochloride, phenethylamine, methyl acrylate, aniline, propionyl chloride and other precursor raw materials.
The 6. encourages citizens to report clues to the illegal and criminal activities of manufacturing, trafficking and smuggling of fentanyl substances and their precursors that have not been discovered or mastered by the public security organs. If it is verified to be true, the public security organs will give a reward of up to 300000 yuan in accordance with relevant regulations.