Notice on Strengthening the Supervision of Drug Purchase and Sale of Drug Operators

Municipal Food and Drug Administration:

In recent years, a small number of pharmaceutical enterprises in our province there are suspected illegal channels from the purchase and sale of counterfeit drugs and other serious violations, resulting in a more serious social impact. To further strengthen the supervision and management of pharmaceutical distribution in the field to ensure the safety of the masses of drugs, the relevant matters are hereby notified as follows:

First, the food and drug regulatory departments at all levels should strengthen the leadership of the drug circulation supervision work, according to the principle of territorial jurisdiction, the development of inspection plans, clear regulatory focus, the implementation of regulatory responsibility to strengthen the area of drug circulation enterprises daily supervision; The performance of regulatory duties, neglect of duty, causing serious consequences, should be seriously investigated the responsibility of the relevant personnel.

Second, all localities in accordance with the province's pharmaceutical market consolidation and unified arrangements to organize a drug quality inspection, focusing on vaccination drugs, blood products, essential drugs, imported drugs, joint ventures and other high-risk drugs, high-value drugs; On the inspection found from the illegal channels to buy and sell counterfeit drugs and other serious violations, in strict accordance with the State Food and Drug Administration State Food and Drug Administration (2007) 714 document requirements, according to "serious" qualitative treatment.

Third, the pharmaceutical business enterprises should take measures to effectively strengthen their own quality management, is strictly prohibited from illegal channels to purchase drugs, is strictly prohibited special drugs into the illegal channels. Where the provisions of the requirements of the acceptance of storage and sales, in the sales process forged into, sales, storage, temperature control and other related data, from illegal channels to purchase drugs or drugs sold to illegal channels, If the circumstances are serious, the enterprise shall be revoked the Certificate of Quality Management for Drug Administration and revoke the License for Drug Operation.

Fourth, the implementation of drug violations case notification system. Drug business enterprises in the course of business if the food and drug regulatory authorities to investigate or administrative office

The applicant shall notify the original issuing unit within 24 hours after receiving the Notice of Notice of Registration or the Administrative Punishment Notice. If it fails to report or conceal the truth and cause serious consequences, it shall be recorded into the enterprise's integrity. File, and through the media to the community exposure.

5, clear the responsibility of the relevant personnel. The drug business enterprise is the first person responsible for the quality management of the unit, the legal person representative of the enterprise, the person in charge of the quality, the person in charge of the quality institution, the quality authorized person and the related drug sales person are the direct responsibility of the quality of the unit's drug sales. Take effective measures to effectively strengthen the supervision and management of relevant personnel, the unit sales of drug sales staff responsible for the responsibility and bear the corresponding legal responsibility. Those who are suspected of selling counterfeit drugs and other illegal acts by the food and drug regulatory authorities to investigate, has not yet closed case, or has made administrative penalties have not yet fulfilled administrative penalties, the relevant direct responsibility shall not be changed to other drug business enterprises; Or negligent sales of counterfeit drugs, resulting in serious violations of the enterprise directly responsible personnel, ten years shall not engage in drug production, business activities.

Sixth, all levels of food and drug regulatory departments to strengthen the dissemination of information on the Internet regulatory information, and strictly regulate the Internet drug information and transaction services; not access to "Internet Drug Information Service Qualification Certificate" illegal website, should be dealt with in accordance with the law and timely transfer The local communications department to be closed; to obtain the "Internet Drug Information Service Qualification Certificate" issued illegal information, ordered the enterprise to be rectified within a time limit; overdue or rectification is still issued after the illegal drug information, should be punished according to law, and promptly Illegal website permission or the record of the provincial communications sector to be closed.