County (city), district drug supervision and management department is responsible for the supervision and management of drug safety within the jurisdiction.
Health, education, public security and other departments in accordance with their respective responsibilities to do a good job related to drug safety. Article IV of drug safety management follow the drug supervision and management departments responsible for the supervision and management of drug production and operation of enterprises as the first responsible person for drug safety is fully responsible for the principle.
Pharmaceutical production and management enterprises and medical institutions must strictly in accordance with the corresponding national quality management standards for production and management activities. Article V drug manufacturers must establish and improve the quality management system and effective production and operation mechanism, the implementation of the "Drug Production Quality Management Standards", clear quality management rights and responsibilities, the implementation of drug manufacturers quality authorized person system. Article 6 The legal representative of a drug manufacturer shall be responsible for the safety of the drugs produced by the enterprise. Drug manufacturers quality authorized person of the enterprise production of drug safety is responsible for supervision.
The quality of drug manufacturers authorized person refers to the appropriate professional and technical qualifications and work experience, authorized by the legal person of the enterprise and in the drug supervision and management department for the record, is fully responsible for the quality of pharmaceutical production of senior professional managers. Article 7 The drug manufacturer shall determine the quality of the authorized person within 15 days from the date of the following information to the municipal drug supervision and management department for the record:
(a) "Drug Manufacturing Enterprises Quality Authorization" copy;
(b) pharmaceutical or related professional college degree or above certificate;
(c) proof of the relevant technical qualifications;
(d) engaged in drug quality management experience proof and proof of identity. quality management experience and proof of identity.
Drug manufacturers need to change the quality of authorized persons, must apply for change in the original filing authority, and shall not change without authorization. Article 8 The quality authorized person of drug manufacturers shall perform the following duties:
(1) to implement the laws, regulations and relevant provisions of drug quality management, organization and standardization of quality management of drug manufacturers;
(2) to organize the establishment and improvement of the enterprise's quality management system of drug production, and monitor the system to ensure that it operates effectively;
(3) to monitor each batch of materials and finished products, and to ensure that it operates effectively;
(4) to ensure that the quality management system of the enterprise is in compliance with the laws, regulations and relevant provisions of drug quality management. (C) for each batch of materials and finished products release, quality management documents, process validation and key process parameters, materials and finished products, internal control quality standards, non-conforming products and product recall of the approval of the exercise of the right to decide;
(D) on the material suppliers, the selection of production equipment, production, quality, materials, equipment and engineering departments, such as key positions in the selection of personnel and other activities that have an impact on product quality Exercise veto power;
(e) the right to decide on the use of drug labels, instructions for use, labels should be issued in accordance with the batch of packaging instructions counting, the number of use, the number of residual and the remaining number of the sum of the number should be the same as the number of collaterals.
The drug manufacturer shall not hinder the quality authorized person to perform his duties. Article IX drug manufacturers have one of the following circumstances, the enterprise quality authorized person shall not be engaged in drug production and management activities within ten years, drug manufacturers must replace the quality authorized person:
(a) serious defects in the enterprise quality management system;
(b) the occurrence of serious drug quality accidents;
(c) in the implementation of GMP in the pharmaceutical work Fraudulent;
(4) adopting deceptive means to obtain the confirmation of filing;
(5) other violations of laws and regulations related to drug management. Article 10 The safety of medication and the management of pharmacies and drugstores in medical institutions shall be implemented in accordance with relevant state laws and regulations. Article XI of the drug retail enterprises shall sell prescription drugs with a licensed physician or a registered rural doctor's prescription, shall not be unauthorized sale of prescription drugs that are prone to abuse and addiction.
Prescription drugs that are prone to abuse and addiction mainly include Federal Cough Dew, Federal Pediatric Cough Dew, Kefir, New Tylenol, Federal Tylenol, Pediatric Federal Tylenol, Mrs. Pei's Cough Dew, Compound Falkodin Oral Liquid, and other compound preparations containing Codeine Phosphate, etc., which can lead to dependence when taken for a long period of time or abused in large doses. Article 12 Drug wholesalers shall adopt the "one-stop" delivery method for the distribution of drugs and implement sunshine distribution. The whole process of distribution should be open and transparent, to ensure that the people's medication is safe, effective, economical and convenient. Article XIII of drug production, management enterprises and medical institutions should use modern information means, monitoring drug production, operation, use and other links, the establishment of drug quality information network monitoring system, the implementation of drug quality information network management. Article 14 Drug production, management enterprises and medical institutions shall use the drug quality information network monitoring system to collect, transmit, store and analyze all kinds of information on the process of drug production, management and use through the combination of digital information and video online. Article XV of drug production, management enterprises and medical institutions should be configured with drug quality information monitoring facilities and equipment required, and to ensure its normal operation, the establishment of drug quality management of the electronic version of the document.