About print and distribute unlicensed medical investigation work specification

The 2016-06-14 national health and population and family planning commission of the People's Republic of China

Countries who supervise 25 [2016] of the state

Provinces, autonomous regions and municipalities directly under the central government health and family planning commission, bureau of traditional Chinese medicine, the xinjiang production and construction corps health bureau, the national center for health and family planning commission supervision:

For further implementation of the law of the People's Republic of China on medical practitioners law of practice \", the \"regulations on the administration of medical institutions\" and other laws and regulations requirements, further standardize unlicensed medical investigation, national health and family planning commission, the state administration of traditional Chinese medicine to make the \"unlicensed practice investigate working rules\" (available from the national health and family planning commission website comprehensive supervision and help stop download). The specification has been examined and passed at the meeting, director of the national health and family planning commission 86th committee, hereby printed and distributed to you, please comply with them.

The national health and family planning commission of the state administration of traditional Chinese medicine

On June 5, 2016

Unlicensed practice investigate job specification

Article 1 for the purpose of regulating the unlicensed medical investigation, on the basis of the professional medical practitioners law of the People's Republic of China, the \"regulations on the administration of medical institutions\" and other laws and regulations, formulate this specification.

In article 2 of this specification is applicable to the local family planning administrative department of health at or above the county level (including management of traditional Chinese medicine, similarly hereinafter) and its supervision and law enforcement agencies, according to the laws, regulations and rules in the area under its jurisdiction without approval to start practice of medical institutions, units and individuals to check its legal liability shall be pursued in accordance with the administrative law enforcement activities. Mainly includes the following unlicensed medical situation:

(a) did not obtain the \"practice license of medical institution\" in medical activities;

(2) the use of forged or altered the \"practice license of medical institution\" in medical activities;

(3) the \"practice license of medical institution\" go through the cancellation registration has been revoked, suspended, or has, continue to conduct clinical activities;

(4) the parties are not in accordance with the provisions, apply for the continuation of the family planning administrative department of public health and will not be accepted, continue or not continue after the expiration of the valid period of the \"practice license of medical institution\" continue to conduct clinical activities;

(5) the provisions of other laws, regulations and rules unlicensed medical behavior.

Article 3 the local family planning administrative department of health at or above the county level responsible for unlicensed medical investigation, local supervision and law enforcement agencies above the county level under the leadership of the family planning administrative department of public health at the same level for unlicensed medical investigation work tasks.

Article 4 the local family planning administrative department of health at or above the county level shall establish a supervision and coordination mechanism, responsible for the communication with other internal departments and between departments coordination, supervision and law enforcement to create conditions.

Article 5 the local family planning administrative department of health at or above the county level shall investigate work of supervision and law enforcement agencies at the same level unlicensed medical to evaluate implementation, the implementation of the law enforcement work.

Local supervision and law enforcement agencies at or above the county level shall conduct law enforcement personnel professional ethics education and skills training for law enforcement, improve the unlicensed practice investigate ability and level.

Supervision and management assistant shall strengthen the daily patrol, found clues unlicensed medical cases shall timely report and assist law enforcement to investigate and punish according to law.

Article 6. The local family planning administrative department of health at or above the county level shall set up and publicly report complaints telephone, clear complaint reporting channels, establishing and perfecting the supervision and management assistance mechanism, collection of unlicensed medical case clues.

Article 7 the local family planning administrative department of health at or above the county level shall establish an unlicensed medical investigation publicity system, to investigate the unlicensed medical case of the public.

Article 8 local family planning administrative department of health at or above the county level shall investigate unlicensed medical cases, should use national health and family planning supervision information query platform unlicensed practitioners always by the administrative punishment case, the suspected criminal cases in a timely manner to. After the implementation of administrative punishment, it shall timely information about the case to the supervision information platform into the national health and family planning.

Article 9 the local family planning administrative department of health at or above the county level shall conduct against unlicensed medical publicity and education activities, to strengthen the social supervision, enhance the public awareness.

Article 10 to report to the society or the daily supervision and unlicensed medical case clues, found in the local family planning administrative department of health at or above the county level shall be accepted by the regulation, and verification. To comply with the regulations of the health administrative penalty procedure case condition, shall, in accordance with the provisions, within 7 days from the date of acceptance shall be put on record. Need because of the special circumstances, the case, it shall fill in the registration within 3 days from the date of filing formalities for examination and approval.

According to the summary procedure of administrative punishment decisions on the spot, and the supervisors should in the administrative punishment decision within 7 days from the date of quote belongs to the family planning administrative department of public health for the record.

Article 11 monitors when investigating unlicensed medical case, have the right to take the following measures:

(a) to the relevant units and individuals to investigate and understand the situation;

(2) to unlicensed medical sites for inspection;

(3) looking up and duplicating and obtaining unlicensed medical related contracts, bills, financial, books and medical records and related data;

(4) after the possible loss or difficult to obtain proof of engaged in unlicensed medical drugs and devices, tools and related items and place, manager's approval by the administrative authority, adopt measures to register and save the evidence;

(5) other measures stipulated by laws, regulations and rules.

Article 12 the supervision personnel to conduct site inspection of unlicensed medical sites, shall make a \"the record\"; To ask the parties or relevant witnesses, it shall make the interrogation record. Supervision, parties, or asked people in accordance with the provisions, and confirm the record and signature.

If the parties or by asking people refuse to sign, sign the record by two or more supervision personnel and indicate the situation, also can invite witnesses witness signature.

Article 13 when the evidence to register and save steps, and the supervisors should make the evidence to register and save the decision, shall be designated place save or in situ preservation.

Article 14 need register save drugs, devices and other items should not be counted on the spot, monitors can use \"seals\" leading packaging, shall be designated place preservation, and inform the parties present opened counting within a time limit.

Parties within the prescribed time limit is not present, the organ deciding on the register and preserve evidence can count by oneself, do not affect the administrative punishment decision. To count, should be implemented by two or more monitors, fill in the item listing, and signature.

Article 15 items, to register and save the organ deciding on the register and preserve evidence shall adopt measures to register and keep the following handling decision within 7 days from the date of making the settlement for register and preserve evidence, and inform the parties:

(a) the verification has nothing to do with the case, in accordance with the law shall be returned;

(2) the verification was relevant to the case, before the implementation of administrative punishment, according to the requirements of the case investigation, as the material evidence;

(3) to confiscate the administrative punishment decision, shall be confiscated in accordance with the law.

In sub-paragraph (2) of the preceding paragraph shall the settlement for register and preserve evidence, the decision can be written as \"XXX's behavior as a result of party suspected of violating the x x x x laws, regulations or rules, have been (quasi) in) x, put on record, the register and save items as evidence.\" .

Article 16 need to draw on the computer, electronic products and Internet related evidence electronic data can be converted into written materials, and indicate the source, time and materials; Field cannot be translated into written materials, can be preserved for carrier to take evidence evidence first registration measures.

Article 17 on the investigation of unlicensed medical behavior of true, local family planning administrative department of health at or above the county level shall, in accordance with the law shall be ordered to stop the practice, and post the announcement in unlicensed medical places.

Article 18 for illegal subject clear, clear facts and evidence sufficient unlicensed medical units and individuals, the local family planning administrative department of health at or above the county level shall make a decision on administrative penalty in accordance with the law.

Article 19 health administrative penalty decision according to law, the local family planning administrative department of health at or above the county level penalty shall be served on the parties concerned. Unaccounted for by the parties or to transfer, lien, delegate, direct mail, such as ways of service could not be served, can take notice. Can notice served to:

(a) in the punishment of the family planning administrative department of public health supervision and law enforcement agencies or bulletin boards or website announcement;

(2) in unlicensed practice of Posting notices, the parties and take photos, video record to post process;

(3) in the public issue of the newspaper announcement.

Served notice announcement shall state the reasons, the contents of the penalty decision, enjoy the rights of the parties in accordance with the law, etc., from the date of announcement deemed to be served as 60 days.

Article 20 the unlicensed medical health administrative penalty decision, the parties within the time limit to perform the punishment of the family planning administrative department of public health shall be based on the law of the People's Republic of China on administrative enforcement law the relevant provisions of the people's court that has jurisdiction for within the time limit stipulated in the following mandatory:

(a) administrative penalty served after the parties did not apply for administrative reconsideration or bring a suit before a people's court, the penalty to be calculated from the day after the expiration of the six months from the date of 3 months;

(2) a written reconsideration decision served after the parties fails to bring administrative prosecution, arrive in 15 days from the date the written reconsideration decision shall be commenced from the date following the expiration of three months;

(3) the administrative ruling of first instance after the parties did not appeal, arrive in 15 days from the date the judgment shall be commenced from the date following the expiration of three months;

(4) the parties did not appeal, after the administrative ruling of first instance in the 10 days of since day introversion of the next day after the expiration of three months.

(5) the administrative judgment of second instance, the said administrative introversion parties is due within 3 months from the date hereof.

The punishment of the family planning administrative department of public health before apply to the people's court for enforcement, it shall demand the parties to fulfil his obligations. Within the book served the expiration of the 10 days from the date the parties are still fails to fulfill its obligations, may apply for compulsory execution.

Article 21 in unlicensed medical investigation, found that the suspected of the crime of illegal medical practice of the following circumstances, shall be in to investigate and punish in accordance with the production of suspected criminal cases transferred to book at the same time, the dependency timely transfer the case to the public security organs in accordance with the relevant provisions, and the suspected criminal cases transferred to book sent to the people's procuratorate at the same level:

(a) without a license to practice medicine by health administrative departments of family planning administrative punishment after twice, once again of unlicensed medical practice;

Mild disability, (2) the cause of patient organ tissue injury lead to general dysfunction, or more than moderate disability, organ, tissue damage cause serious dysfunction or death;

(3) of a class infectious disease spread, popular, or has spread, popular dangerous;

(4) using fake medicines and medicines of inferior quality, or do not conform to the provisions of the state standard of hygiene materials, medical equipment, enough to cause serious damage to human body health.

(5) other situations if the circumstances are serious.

To have administrative penalty cases suspected of the crime of illegal medical practice, the local family planning administrative department of health at or above the county level shall be made in the administrative punishment in accordance with the provisions of the preceding paragraph within 10 days from the date of the transfer.

Article 22 the local family planning administrative department of health at or above the county level find criminals on probation or parole test of illegal medical practice during the period of practicing medicine without a license again, it shall, at the time in accordance with the law to investigate informed of community correction to the judicial organs.

Article 23 the local family planning administrative department of health at or above the county level in the investigated unlicensed medical case found suspected of illegal sale of drugs, or suspected of selling fake medicines and medicines of inferior quality, food and drug supervision and administration department in accordance with law, shall be handed over to the same treatment.

Article 24 the local family planning administrative department of health at or above the county level and their supervision and law enforcement agencies and law enforcement personnel in the process of unlicensed medical practice and not to take the responsibility of the provisions of this specification and procedures, in any of the following circumstances, shall be in accordance with the relevant provisions of the supervision and law enforcement fault liability shall be investigated for responsibility:

(a) to have the exact source of complaints to report unlicensed medical case clues YaAn don't check, ManAn don't quote, thereby causing serious consequences;

(2) find the laws and regulations clearly define for unlicensed medical behavior will not be in a timely manner to investigate and punish, neglect their duties, thereby causing serious consequences;

(3) in the process of administrative law enforcement, fraud, embezzlement, shield, allowed unlicensed medical, thereby causing serious consequences;

(4) found that unlicensed medical behavior is not in a timely manner in accordance with the law shall be ordered to stop the practice, thereby causing serious consequences;

(5) find unlicensed medical behavior suspected of a crime is not timely transferred to public security organs, thereby causing serious consequences;

(6) to obtain, from unlicensed medical property or seek other illegitimate gains by the parties.

Article 25 the provincial family planning administrative department of public health can be combined with the region's actual execution of the specific provisions of this specification.

Article 26 the standards come into force from the date of release.