Chapter 1 General Principles
Article 1 is to strengthen drug safety supervision，Safety safety for public medication，According to the "Pharmaceutical Management Law of the People's Republic of China"、"Implementation Regulations of the People's Republic of China Pharmaceutical Management Law"、"Special Regulations on Strengthening the Safety Supervision and Management of Food and other products such as food"，Formation of these measures。
The recall of drugs sold in the people's Republic of China and its supervision and management，Applicable these Measures。
Article 3 The drug recall of these Measures，refers to a pharmaceutical manufacturer (including foreign pharmaceutical manufacturers of imported drugs，Same below) Recovery medicines that have been listed on sale in accordance with the prescribed procedures。
4 The hidden dangers of safety hazards in these Measures，refers to due to research and development、Production and other reasons may make the unreasonable danger of having the health of the medicine and the safety of life。
5 Drug stake online sports bettingproduction enterprises shall establish and improve the drug recall system in accordance with the provisions of these Measures，Related information about drug safety，Investigate the medicines that may have hidden safety hazards、Evaluation，Recall medicines with hidden safety hazards。
Drug business enterprises、Use unit shall assist pharmaceutical manufacturers to perform the recall obligation，Discard it in time according to the requirements of the recall plan、Feedback drug recall information，Control and recover drugs with hidden safety hazards。
Article 6 Drug Operation Enterprise、Use unit to find its operation、Drugs used are available for safety hazards，Should stop sales or use the drug immediately，Notify the drug manufacturer or supplier，Report to the drug supervision and management department。
Seventh pharmaceutical manufacturer、Business enterprises and use units shall establish and preserve complete purchase and sales records，Make sure the traceability of the sales drugs。
Article 8 The province of the stake online sports bettingproduction enterprise where the drug is recalled、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government is responsible for the supervision and management of drug recalls，Other provinces、Autonomous Region、The drug supervision and management department of municipality directly under the Central Government shall cooperate with、Assistance to do a good job of recalling drug recall。
The State Food and Drug Administration supervises the management of national drug recalls。
1 The National Food and Drug Administration and the province、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government shall establish a system of public drug recall My stake betting appinformation，Pharmaceutical information and drug recalls that have a valid route have been published to the society。
Chapter II Survey and Evaluation of Pharmaceutical Safety Danger Article 10 Drug stake online sports bettingproduction enterprises shall establish a sound drug quality assurance system and drug adverse reaction monitoring system，Collection、Record the quality of the drug and the adverse reaction information of the drug，and report to the drug supervision and management department in a timely manner。
Article 11 Drug stake online sports bettingproduction enterprises shall investigate the hidden safety hazards that may exist in the drug。
Drug supervision and management department conducts investigations on possibilities of safety hazards in drugs，Drug stake online sports bettingproduction enterprises should assist。
Drug business enterprises、14053_14090，Provide relevant information。
Article 12 The content of the survey of hidden dangers of drug safety shall be determined according to the actual situation，It can include:
(1) Types of adverse events in drugs、range and reason;
(2) Whether the use of drugs meets the drug instructions、Indications specified in the label、Dosage of usage;
(3) Whether the quality of the drug meets national standards，Whether the drug production process meets the regulations of GMP，Is the process and approval process of drug production and approval;
(4) Whether the drug storage and transportation meet the requirements;
(V) The composition and proportion of the main use of the drug;
(6) Pharmaceutical batches that may have hidden safety hazards、quantity and circulation area and scope;
(7) Other factors that may affect drug safety.
Article 13 The main content of the evaluation of hidden dangers of drug safety includes:
(1) The possibility of the drug caused by this drug，Whether it has caused harm to human health;
(2) The hazards of the main use population;
(3) For special crowds，Especially the hazard effects of high -risk groups，Such as an old age、Children、Pregnant women、Liver and kidney dysfunction、Surgical patients, etc.;
(4) Severe and urgency of harm;
(5) The consequences of harm.
Article 14 Depending on the severity of the hidden dangers of drug safety，Drug recall is divided into:
(1) First -level recall: The use of this drug may cause serious health hazards;
(2) Class 2 recall: The use of this drug may cause temporary or reversible health hazards;
(3) Level 3 recall: The use of this drug generally does not cause health hazards，But for other reasons, it needs to be recovered。
Drug stake online sports bettingproduction enterprises shall be based on the recall class and drug sales and usage，Scientific Design Drug Recall Program and organize implementation。
Chapter III Active Recall
Article 15 Drug stake online sports bettingproduction enterprises shall analyze the collected information，For medicines that may exist in safety hazards, according to Article 12 of these Measures、The requirements of Article 13 to investigate and evaluate，Discovering the hidden safety hazards of drugs，It should be decided to recall。
Imported drugs for overseas pharmaceutical manufacturers to implement drug recalls abroad，The State Food and Drug Administration shall be reported in time; recalled in the country，The import unit is responsible for the specific implementation in accordance with the provisions of these Measures。
Article 16 After making a drug recall decision，The recall plan should be formulated and organized，The first -level recall is within 24 hours，The secondary recall is within 48 hours，Level 3 recall within 72 hours，Notification to the relevant drug business enterprise、Use unit to stop sales and use，At the same time to the local province、Autonomous Region、Report on the drug supervision and management department of municipality directly under the Central Government。
Article 17 After the drug stake online sports bettingproduction enterprise starts the drug recall，The first -level recall is within 1 day，The second -level recall is within 3 days，Level 3 recall within 7 days，The investigation and evaluation report and recall plan shall be submitted to the local province、Autonomous Region、Drug supervision and management department of municipality directly under the Central Government。Provincial、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government shall submit the survey report and recall plan to report the first -level drug recall report to report the State Food and Drug Administration。
Article 18 The survey and evaluation report shall include the following content:
(1) The specific situation of recalling medicine，Including names、Batch and other basic information;
(2) The reasons for the recall;
(3) The results of the survey and evaluation;
(4) Recall grading.
The recall plan shall include the following:
(1) The production and sales of drugs and the number of recovery;
(2) The specific content of recall measures，Including the implementation of the organization、range and time limit, etc.;
(3) The way and scope of the recall information;
(4) The expected effect of recall;
(5) treatment measures after the recall of drugs;
(6) The name and contact information of the contact person.
Article 19 province、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government can organize experts to evaluate the recall plan submitted by drug manufacturers in accordance with the actual situation，It is believed that the measures taken by pharmaceutical manufacturers cannot effectively eliminate hidden safety hazards，It can be required to require drug manufacturers to adopt the scope of recall、Short the recall time and other more effective measures。
Article 20 Drug stake online sports bettingproduction enterprises change the recall plan for reporting，It should be reported to the drug supervision and management department for record。
21 Drug stake online sports bettingproduction enterprises in the process of recalling，First -level recall，Third -level recall every 7 days，Third -level recall every 7 days，province where the location is located、Autonomous Region、The drug supervision and management department of the municipality reports the progress of drug recall。
Article 22 Drug stake online sports bettingproduction enterprises shall have a detailed record of the treatment of recalled drugs，and province to the location of the drug manufacturer、Autonomous Region、Report on the drug supervision and management department of municipality directly under the Central Government。Drugs that must be destroyed，Destruction should be destroyed under the supervision of the drug supervision and management department。
Article 23 After the recall is completed，It should be evaluated to the recall effect，province where the location is located、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government submits a summary report of the drug recall。
Article 24 province、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government shall review the report within 10 days from the date of receiving the summary report，and evaluate the recall effect，Organize experts to review and evaluate if necessary。Examination and evaluation conclusions shall notify the drug stake online sports bettingproduction enterprise in writing。
After review and evaluation，It is believed that the recall is not thorough or needed to take more effective measures，The drug supervision and management department shall require drug manufacturers to recall or expand the scope of recall。
Chapter 4 Order recall
Article 25 The Drug Supervision and Administration Department is investigated and evaluated，It is believed，Pharmaceutical manufacturers shall recall the medicine without active recall，Drug stake online sports bettingproduction enterprises should be ordered to recall drugs。
When necessary，The drug supervision and management department can require drug stake online sports bettingproduction enterprises、Operating enterprises and use units immediately stop sales and use the drug。
Article 26 The drug supervision and administration department shall make order to recall the decision，shall order the recall notice to the drug stake online sports bettingproduction enterprise，Notice includes the following:
(1) The specific situation of recalling medicine，Including names、Batch and other basic information;
(2) The reasons for the recall;
(3) The results of the survey and evaluation;
(4) Recall requirements, including scope and time limit.
27 Drug stake online sports bettingproduction enterprises after receiving the order of recall，It should be in accordance with Article 16 of these Measures、Article 17 stipulates that drug business enterprises and use units，Formulate、Submit the recall plan，Organize implementation。
Article 28 Drug stake online sports bettingproduction enterprises shall be in accordance with Article 20 of these Measures、Article 21、Article 22、Article 23 The provisions of reporting to the drug regulatory department report the relevant situation of drug recall，Follow -up treatment of recall medicines。
The drug supervision and management department shall review the drug recall summary report submitted by the drug manufacturer in accordance with Article 24 of these Measures，and evaluate the recall effect。After review and evaluation，It is believed that the recall is not thorough or needed to take more effective measures，The drug supervision and management department may require drug manufacturers to recall or expand the scope of recall。
Chapter 5 Legal Responsibility Article 29 The Drug Supervision and Administration Department confirms that drug manufacturers have violated the law、Regulations、Regulations stipulate that there are hidden safety hazards caused by listed drugs，Administrative penalties should be given in accordance with the law，But the company has taken recall measures to actively eliminate or reduce the consequences of harm，In accordance with the provisions of the Administrative Penalty Law, it is light or reduced penalty; illegal acts are slightly and corrected in time，No harmful consequences，No punishment。
Drug stake online sports bettingproduction enterprise recalls drugs，It can inevitably take other legal liabilities that should be assumed in accordance with the law。
Article 30 Drug manufacturers violate the provisions of these Measures，It is found that there are hidden safety hazards in the drug without actively recalling the medicine，Order to recall medicine，Fined fines with a value of 3 times the value of the drug in the recalled drug;，Certificate of Certificate Approval Certificate for the Certificate Department，Until the revocation of "Drug Production License"。
Article 31 Drug manufacturers violate Article 25 of these Measures，Refusing to recall the medicine，A fine of 3 times the value of the drug value of the recalled drug; the serious consequences，Certificate of Certificate Approval Certificate for the Certificate Department，Until the revocation of "Drug Production License"。
Article 32 Drug manufacturers violate Article 16 of these Measures，No drug business enterprise is notified within the specified time、Use unit to stop selling and use drugs，Warning，Order to correct the time limit，Paimated a fine of less than 30,000 yuan。
Article 33 Drug manufacturers violate Article 19 of these Measures、Article 24, paragraph 2、Article 28, paragraph 2 provisions，Failure to take correction measures or recall drugs in accordance with the requirements of the drug supervision and management department，Warning，Order to correct the time limit，Paimated a fine of less than 30,000 yuan。
Article 34 Drug manufacturers violate the provisions stipulated in Article 22 of these Measures，Warning，Order to correct the time limit，Paimated a fine of less than 30,000 yuan。
Article 35 of the pharmaceutical manufacturer has one of the following circumstances，Warning，Order to make corrections within a time limit;，Fined fines below 20,000 yuan:
(1) Failure to establish a drug recall system in accordance with these Measures、Drug quality assurance system and drug adverse reaction monitoring system;
(2) Refusing to stake online sports bettingassist the drug supervision and management department for investigation;
(3) The investigation and evaluation report and recall plan of the drug recall cannot be submitted in accordance with the provisions of these Measures、Pharmaceutical recall progress and summary report;
(4) Change the recall plan，Not reported by the drug supervision and management department。
Article 36 Drug Operation Enterprise、Use unit violates the provisions of Article 6 of these Measures，Order to stop sales and use，Put a fine of 10,000 yuan and 50,000 yuan; cause serious consequences，A revoked "Drug Business License" or other licenses was revoked by the original certificate department。
Article 37 Drug Operation Enterprise、Use unit refuses to cooperate with drug stake online sports bettingproduction enterprises or drug supervision and management departments to conduct surveys on hidden dangers of drug safety、Refusing to assist pharmaceutical manufacturers to recall drugs，Warning，Order to correct，It can be fined below 20,000 yuan。
Article 38 of the drug supervision and management department and their staff do not perform their duties or abuse their powers，According to relevant laws、Regulations are handled by regulations。
Chapter 6 Attachment
Article 39 This Measures shall be explained by the State Food and Drug Administration。
Article 40 These Measures will be implemented from the date of announcement.
