Release date: 2016-05-25
The two-vote system has really come, and the drug regulatory authorities in many places are carrying out unannounced inspections on drug operations.
The Hubei Provincial Food and Drug Administration issued the "Hubei Province Food and Drug Safety Unannounced Inspection and Inspection Measures (Trial)" notice on May 17 to clearly indicate that the drug producers and operators are strictly inspected to implement the drug safety main responsibility, including system construction and implementation, raw materials or The implementation of food and drug purchase inspection, operation procedures, product inspection, safety and health management, quality assurance system and other responsibilities.
The unannounced visits were conducted by randomly selecting the "double random" random inspection mechanism for unannounced visits and randomly selected unannounced visits. The unannounced visits should adhere to the "four noss and two straights", that is, no notice, no greeting, no escort, no reception, and direct entry into the grassroots. Go straight to the scene.
For general problems found in violation of food and drug safety production and operation norms during unannounced visits, the unannounced inspection team may report back to the relevant departments and units on the spot or afterwards, and order the rectification within a time limit. When necessary, send an unannounced visit to check the food and drug supervision department to interview relevant responsible units and responsible persons. If it is a violation of laws and regulations in production and operation, the unannounced inspection team will report the case clues to the inspection department after reporting to the bureau leader.
The documents issued this time are not unfounded. In the past few days, the news that a representative of the four major families in Hubei has been arrested has been reported. Although 39 Medicine Jun does not recognize the accuracy of the news, it is undeniable that the environment of the pharmaceutical distribution industry is undergoing earth-shaking changes.
According to 39 Medicine, the unannounced visits are not only found in Hubei Province, but also in Henan, Hebei, Sichuan, Tibet and other places. In such a large environment, how should terminal representatives survive?
39 Medicine Jun recommends that the majority of small partners, as soon as possible to seize the terminal sales resources, the future of the pharmaceutical industry is "the end of the world to get the world" era, as long as you can master the terminal sales channels, you will have a place to live .
In addition, 39 Medicine Jun also combed these unannounced visits and found that the details of unannounced visits that are worthy of attention by the majority of pharmaceutical marketers, agents, and pharmaceutical manufacturers are:
1. Unannounced visits refer to random inspections conducted by the food and drug supervision and administration department on food production and operation, drug development, production, operation, use and other units without prior notice.
2. Unannounced visits and inspections must follow the principles of legal compliance, seeking truth from facts, being objective and fair, and being prudent and timely. The results of inspections serve as an important basis for the performance appraisal of food and drug safety objectives and the evaluation of credit ratings for enterprises.
3. Unannounced visits and inspection personnel may be transferred from the food and drug supervision and administration departments at all levels and their inspection technical institutions, or jointly with relevant functional departments, news media and other units.
4. The food and drug production and operation personnel shall implement the responsibility of the main body of food and drug safety, including the system construction and implementation, the inspection of raw materials or food and drug purchase inspection, the implementation of operational procedures, product inspection, safety and health management, and quality assurance system.
5, unannounced visits should adhere to the "four no two straight", that is, no notice, no greetings, no escort, no reception, straight into the grass, go straight to the scene. A “double random†random inspection mechanism was conducted to randomly select unannounced visits and randomly select unannounced visits.
6. In the unannounced visit inspection, the general problems that violate the food production safety management norms may be reported to the relevant departments and units on the spot or afterwards, and ordered to be rectified within a time limit.
7. For the larger problems found in the unannounced visit inspection, the unannounced interview group will report to the approved bureau leaders, and notify the relevant departments or food and drug production operators of the rectification requirements. When necessary, send an unannounced visit to check the food and drug supervision department to interview relevant responsible units and responsible persons. If it is a violation of laws and regulations in production and operation, the unannounced inspection team will report the case clues to the inspection department after reporting to the bureau leader.
8. Sending unannounced visits to the major problems found in unannounced visits, or possibly causing regional and systemic risks, the food and drug supervision and administration department shall report to the leaders of the superior food and drug supervision and management departments in a timely manner, analyze and judge the situation, and propose research. Treatment method. If necessary, report to the Provincial Food and Drug Safety Committee and notify the local government.
9. Food and drug producers and operators who refuse to accept inspections after unannounced visits by the unannounced visitor may be given administrative penalties in accordance with relevant regulations. If the circumstances are serious and threatened by violence or use violence to resist inspection, it shall be reported to the local public security organ for disposal.
Notice attached to the Hubei Food and Drug Administration on Printing and Distributing the "Measures for the Unannounced Inspection of Food and Drug Safety in Hubei Province (Trial)"
E Food and Drug Supervision [2016] No. 64
Municipal, State, Zhiguan City, Shennongjia Forest District Food and Drug Administration, relevant departments of the Provincial Bureau, relevant units:
In order to further strengthen food and drug safety supervision and management, standardize supervision and inspection procedures, and urge food and drug producers and operators to implement safety main responsibility, according to relevant laws and regulations, the Provincial Food and Drug Administration has formulated the Hubei Province Food and Drug Safety Unannounced Inspection and Inspection Measures. (Trial). It is now issued, please follow the instructions.
Hubei Food and Drug Administration
May 17, 2016
(Public attribute: active disclosure)
Hubei Province Food and Drug Safety Unannounced Inspection and Inspection Measures (Trial)
Chapter I General Provisions
The first one is to strengthen the supervision and inspection of food and medicine (including four products, one machine, the same below), implement the "four most stringent" requirements, and actively discover outstanding problems and weak links in the process of food and drug production and management, and promptly correct problems and eliminate them. Hidden dangers, urged the main responsibility of the enterprise to be implemented, in accordance with the "Food Safety Law", "Drug Administration Law", "Regulations on the Supervision and Administration of Medical Devices" and the relevant requirements of the State Council and the provincial government on strengthening the supervision of food and drug safety, combined with the actual work, Formulate these measures.
Article 2 The unannounced inspection of food and drug safety referred to in these Measures refers to random inspections conducted by the food and drug supervision and administration department on food production and operation, drug development, production, operation, use and other units without prior notice.
Article 3 The Provincial Food and Drug Administration is responsible for organizing the implementation of unannounced inspections of food and drug safety throughout the province. The food and drug supervision and administration departments at all levels are responsible for organizing the implementation of unannounced inspections of food and drug safety in their respective administrative regions.
Article 4 The implementation of unannounced inspections of food and drug safety is an important way to strengthen the supervision of food and drug safety. The results of unannounced visits are an important basis for the performance appraisal of food and drug safety objectives and the evaluation of credit ratings for enterprises.
Article 5 The conduct of unannounced visits and inspections must follow the principles of compliance, truth-seeking, objective and fair, prudent and timely.
Article 6 According to the needs of the work, unannounced inspectors may be transferred from the food and drug supervision and administration departments at all levels and their inspection technical institutions, or jointly with relevant functional departments, news media and other units.
Chapter II Unannounced Visits
Article 7: Carry out unannounced visits and check the hidden dangers, expose problems, pursue responsibility, promote rectification, combine the characteristics of food and drug safety, and the outstanding problems exposed in the work and related accidents.
(1) The implementation of food and drug production and management laws and regulations, rules, standards and systems for food and drug safety;
(2) The implementation of food and drug safety main responsibility of food and drug production and operation personnel, including system construction and implementation, inspection of raw materials or food and drug purchase inspection, implementation of operational procedures, product inspection, safety and health management, quality assurance system;
(3) The food and drug production and operation operators during major holidays and activities and during important periods shall implement the main responsibility and engage in production management according to law;
(4) The implementation of various comprehensive management and special rectification work carried out by food and drug production and operation operators and the rectification of problems;
(5) Food and drug safety issues in complaints and reports, media exposure, sampling inspections, and food and drug safety hot issues of concern to the society.
(6) Other food and drug safety work that requires unannounced visits.
Chapter III Organization and Implementation
Article 8 The unannounced visit inspection shall be strictly in accordance with the working procedures and shall be implemented in closed loop.
Article 9 Before carrying out unannounced visits, a rigorous and meticulous work plan shall be formulated. After being submitted to the leadership of the bureau at the same level for approval and approval, it shall be organized in accordance with relevant laws and regulations.
Article 10 The unannounced visits shall be conducted by means of on-the-spot investigations, unannounced visits, interviews with specific persons, sampling inspections, etc., through means of audio and video recording, telephone consultation, and simulation services.
Article 11 The "double random" random inspection mechanism for random unannounced inspections and randomly selected unannounced inspectors is implemented. The unannounced visit shall be subject to the responsibility of the team leader and shall be attended by 2 or more persons with administrative law enforcement qualifications. According to the needs of the work, relevant experts, NPC deputies, CPPCC members, inspection technicians and media reporters may be invited to participate.
Article 12: Unannounced visits must adhere to the "four no two straight", that is, no notice, no greeting, no escort, no reception, straight into the grassroots, straight to the scene. In case of emergency, the local food and drug supervision and administration department may be notified to cooperate with the work.
Article 13 The object, time, place and matters of the unannounced visit inspection shall be determined by the food and drug supervision and administration department that conducts unannounced visits and inspections by the organization.
Article 14 The members of the unannounced visit inspection team shall concentrate at the designated place, unify the place and unit to be inspected, and do confidential work for unannounced visits.
Article 15 The unannounced visit inspection team shall record in detail the inspection time, place, on-site condition of the object to be inspected, existing problems, etc., record or photograph the discovered problems, make copies of relevant documents and materials, and investigate and inquire about relevant personnel. . If necessary, the problem of discovery may be referred to or submitted to the food and drug supervision department with jurisdiction to take corresponding administrative measures according to law.
Article 16 If a food and drug production and operation operator disagrees with the result of an unannounced visit, it may make a statement or defense in accordance with the law.
Article 17 After the unannounced visit inspection, the unannounced visit inspection team shall promptly write an unannounced visit inspection report, and put forward the handling suggestions, and submit it to the food and drug supervision and administration department at the same level or the food and drug supervision and administration department with jurisdiction to deal with it in the following manner.
(1) If there are violations of laws and regulations, they shall be investigated and punished according to law.
(2) Those involved in the supervision of other departments shall be handed over in a timely manner.
(3) Anyone suspected of committing a crime shall be transferred to the judicial organ in a timely manner.
Chapter IV Problem Disposal
Article 18 The general problems of violations of food and drug safety production and operation norms found in unannounced visits may be reported to the relevant departments and units on the spot or afterwards, and ordered to be rectified within a time limit.
Article 19 For the larger problems found in the unannounced visit inspection, the unannounced interview group shall report to the approved bureau leaders, and notify the relevant departments or food and drug production operators of the rectification requirements. When necessary, send an unannounced visit to check the food and drug supervision department to interview relevant responsible units and responsible persons. If it is a violation of laws and regulations in production and operation, the unannounced inspection team will report the case clues to the inspection department after reporting to the bureau leader.
Article 20: Sending unannounced visits to the major problems found in unannounced visits, or possibly causing regional and systemic risks, the food and drug supervision and administration department shall promptly report to the leaders of the food and drug supervision and administration departments of the higher levels, and analyze the situation of the judgment. The study proposes a treatment. If necessary, report to the Provincial Food and Drug Safety Committee and notify the local government.
Article 21 The requirements for the handling of problems raised by unannounced visits shall be unreasonably prolonged and falsified by the subordinate food and drug supervision and administration department. If the notice of rectification and rectification is received but is not actively implemented or refused to be implemented, the superior food and drug supervision and administration department may If the case is serious, the person concerned shall be investigated for the responsibility of the relevant unit and relevant personnel in accordance with relevant regulations.
Article 22 Food and drug producers and operators who refuse to accept inspections after unannounced visits by the unannounced visitor may be given administrative penalties in accordance with relevant regulations. If the circumstances are serious and threatened by violence or use violence to resist inspection, it shall be reported to the local public security organ for disposal.
Chapter 5 Work Discipline
Article 23 The food and drug supervision and administration departments at all levels and unannounced visits and inspection personnel shall strictly abide by the discipline of unannounced visits and inspections.
(1) The staff of unannounced visits and inspections must strictly abide by the relevant laws, regulations, rules and regulations of the state and the rules of honesty and self-discipline, and carry out relevant work according to law.
(2) The food and drug supervision and administration department and the unannounced inspection and inspection personnel must strictly abide by the relevant work system and strictly abide by the work discipline. Unauthorized disclosure of relevant information, whistleblower information and trade secrets of the unit under inspection shall not be disclosed. It is not allowed to take the opportunity to seek personal gains and is not allowed to obey justice.
(3) Those who violate the unannounced visit inspection discipline, disclose the contents of the inspection beforehand, accept bribes from the object under examination, and conduct acts of cover-up concealment, malpractice for personal gains, abuse of power, etc., must be held accountable.
(4) The funds for unannounced visits and inspections shall be borne by the dispatched unit, and accommodation and accommodation shall be arranged by themselves, and reception or gifts from local regulatory authorities and enterprises shall not be accepted.
(5) The work report shall be formed at the end of the unannounced visit, and cases involving administrative punishment and illegal crimes shall be promptly transferred to the relevant departments. In case of violations of regulations by administrative supervisors, they shall promptly copy and report to the discipline inspection and supervision organization.
(6) The news articles formed by the follow-up media shall be released after being examined and approved by the main leaders of the organization.
Chapter VI Supplementary Provisions
Article 24 The municipal food and drug supervision and administration departments may formulate detailed implementation rules for food and drug safety unannounced visits in light of local conditions.
Article 25 These Measures shall come into force as of the date of promulgation.
Source: 39 medicine
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