Advanced Search

Shaanxi Province, Medical Institutions, Pharmaceutical And Medical Device Management

Original Language Title: 陕西省医疗机构药品和医疗器械管理办法

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$40 per month.

(Act No. 115 of the People's Government Order No. 115 of 4 November 2006 on 10 December 2006)

In order to strengthen the management of medical institutions' medicines and medical equipment, the safe and effective use of medicines and medical equipment is guaranteed, in accordance with the People's Republic of China's Medicine Management Act, the National People's Republic of China's Drug Management Act, and the Medical Assurance Management Regulations and the relevant laws, regulations and regulations, to develop this approach in the light of the practice of the province.
Article 2
The medical institutions referred to in the previous paragraph include hospitals, maternity and child health institutions, hygienic institutions, nursing homes, clinics (individuals), health clinics (indoors), first aid centres (stays), sickness control boards (stays, stations), care centres (stations), community health services centres (stays) and family planning technology services.
Article 3. The Ministry of the People's Government's Food Drugs Monitoring Authority is responsible for the supervision of the whole provincial medical institutions for the management of medicines and medical equipment. The Food Control Administration of the Municipal, District and People's Government is responsible for monitoring the management of pharmaceutical and medical equipment in medical institutions within the administration.
The Government of the people at the district level is responsible for the management of the relevant supervision of medical institutions' medicines and medical equipment within their respective responsibilities.
Article IV Medical institutions shall, in the context of the drug use of the medical treatment subject approved by the law, the family planning technology service project, receive medicines from practitioners, practitioners or village doctors who have obtained a certificate of registration in the rural doctor.
Article 5 Medical institutions may establish pharmacies or pharmacies in accordance with the relevant provisions of the State.
Medical institutions set up pharmacies or pharmacies, which should be in line with the regulatory norms developed by sectors such as the Government's food medicine surveillance.
Article 6 Medical institutions such as the Office of the Ombudsman and the Clinic shall not be equipped with drugs other than those that are commonly used for medicines and first aid. Using drugs, the scope and variety of first-aid medicines, which are developed and published by the Provincial Government's Health Administration, together with the Ministry's Government's Food Medicine Monitoring Administration.
The scope of the drug use of the family planning technology services should be consistent with the authorized range of services, services projects, operating articies, and should not be used for the basic use of medicines in the family planning technology services to obtain medical authorizations. The basic pharmacies of the Family Planning Technology Service are developed and published by the Ministry's Government's Food Medicine Monitoring Administration with the provincial Government's Government's family planning administration.
The scope and variety of medicines used by medical institutions under article 6 of this approach shall not be subject to unauthorized changes. Changes should be reported in accordance with the law by the host food medicine surveillance management, the health administration or the family planning administration.
Article 8. Medical institutions shall be exempt from the production of medicines that have a licence for the production of medicines or a licence for the operation of drugs, the acquisition of medicines by the operation of the enterprise, except in the management of the approved text. The village health room, the personal clinic may also be entrusted to the commune in the town of commune for the purchase of medicines or for distribution by local drug distribution centres.
In the town's commune for the procurement of medicines, it should be held in the village health room, the commissioner of the individual clinic and receive oversight inspections by the host food medicine surveillance management.
Article 9. Medical institutions should purchase drugs and should establish a system of inspection of inspection tests, the identification of qualified medicines and other markings, and the non-removability of requirements.
Article 10 Medical institutions should establish authentic and complete drug purchases in accordance with the provisions of the legislation. A record-keeping period for drug purchases shall not be less than three years; the effective period for medicines exceeds three years and is maintained for one year after the effective expiry of the medicines.
Article 11. Medical institutions should redeploy medicines from their ranks, without mailing, falsification, counter-stamping self-selection and diagnosis, sale, counselling, probation, marketing and other forms of operation or trans-shipment of drugs.
Article 12 Medical institutions should develop and implement systems for the custody of medicines to ensure the quality of medicines in accordance with the provisions relating to the quality of medicines.
Medical institutions should be kept on a regular basis.
Article 13 quantifications, packaging materials, containers and working environments for therapeutic institutions should be in line with health requirements to prevent contamination of drugs.
The treatment of medicines by medical institutions requires the destruction of medicines for the least packagings, which should be kept in a piecemeal record and the retention of the smallest packaging and drug statements until the sale is completed. The trajectory of a piecemeal substance should indicate the contents of the drug name, specifications, use, quantity and duration.
Article 14. Medical institutions in the hospital category have been approved for the distribution of pharmacies, with the approval of the Ministry's Government's Food Medicine Monitoring Administration, which may entrust the manufacturer of medicines or the placement of medical institutions with the Procedural Permit.
Article 15. Internal sections of the medical institution shall not be privately established, and medical institutions shall not be able to sell drugs and preparations in private.
Medical institutions do not authorize the use of other medical institutions for the preparation of the preparations.
Article 16 does not use pseudo-female medicines or medicines.
Medical agencies have found false medicines and poor medicines in the use of medicines, and should immediately cease their use and report to the host food drug control supervisory authorities in a timely manner and not be processed.
Medical institutions have found that quality of suspicious drugs should be suspended, along with the inspection of drug testing institutions; testing is defined as curatives, poor medicines should be reported in a timely manner to host food drug surveillance authorities.
Article 17 Medical institutions should conduct health inspections every year and establish health files. Persons with infectious diseases, suspected communicable diseases and other diseases that may be contaminated with drugs may not be involved in direct access to medicines.
Medical institutions are involved in the procurement, custody, maintenance, inspection and distribution of medicines and should receive professional training and continuing education. The State stipulates that professional qualifications should be obtained from its provisions.
Article 18 Medical institutions may not use medical operations to advertise drug propaganda, and their assigned agents shall not be subject to advertising.
Article 19 Medical institutions should buy medical equipment from the production of a licence for the production of an enterprise for the production of a medical device or a licence for a medical operator to operate.
Medical institutions should be able to purchase medical equipment, and a system of inspection tests should be put in place, a certificate of eligibility and other markings for the identification of medical equipment products, without registration, qualification, expiry, phase-out or non-registration criteria.
Article 20
(i) Medical trademarks and names, specifications (phasitions), quants, effective extinguish products should also be recorded;
(ii) The number of purchases, the purchase price and the date of purchase;
(iii) A copy of the business licence for the manufacturer, supply unit, a copy of the medical equipment registration certificate, a copy of the licence for the production of an enterprise for the production of a medical device or a copy of the licence for the manufacturer of the supply unit;
(iv) The findings of the receipt, signed by the holder, the head of the authority or chapter.
A record-keeping period shall not be less than one year after the expiry of the product's effectiveness or one year after the end of the use, and a record of the acquisition of vegetation medical equipment shall be maintained permanently.
Article 21 stores for medical institutions that store medical equipment should be in accordance with the conditions laid down by the law, regulations, or the authorities for food medicine surveillance in the province.
No medical body may use medical equipment that is not registered, is not qualified, expired, phased out or does not meet the registration criteria. Medical institutions should not be able to expand the use of medical equipment at the clinical trial stage.
Medical equipment developed by medical institutions should be used in this unit and cannot be sold to the market.
Article 23 Medical institutions should carefully check their packaging before using sterilized medical devices. Package for direct contact with medical devices should be disrupted and processed in accordance with the relevant provisions.
The special equipment used by medical institutions and the measurements included in the National Forced Approval List should be used by the quality technical supervision of the licensee designated by the executive.
The use of vegetation medical equipment by medical institutions should be recorded. The record includes:
(i) The name, address, telephone;
(ii) The date of the operation, the name of the physician;
(iii) Names of products, specifications (phasitions), directory of production plants, production orders (releading factor numbers or serials), date of production;
(iv) The supply unit, the date of acquisition, the address of the supply unit and the telephone.
The record of the use of vegetation medical equipment should be kept permanently.
Article 25 Medical institutions should implement the provisions of the State Department and provincial government price authorities relating to drug prices. Medicines for government pricing, government guidance and government price interventions are not allowed to increase prices in any way. The procurement of medicines by means of solicitation by law should be made, and the procurement by law should be made to reduce the prices of medicines. The prohibition of riots and the damage to prices of patients' interests is prohibited.
Medical institutions should introduce price announcements, referral systems for pharmaceuticals, medical devices used by patients, and supply a list of medicines, medical devices to patients in fact.
Article 26 Medical institutions should follow up on the quality, effectiveness and responsiveness of the use of medicines and medical equipment by this unit, in accordance with the relevant national provisions. In identifying adverse responses that may be relevant to the use of drugs or equipment, reports should be made promptly to the provincial Government's food medicine surveillance management, the health administration or the family planning administration.
Article 27, in violation of article 6, paragraph 2, and Article 7, of this approach, is changing the time limit for the management responsible for the surveillance of food medicines at the location; is overdue with fines of up to €200 million.
Article 28, in violation of article 10 and article 21 of this approach, is being corrected by the management responsible for the surveillance of food medicines at the location and fines of up to $3000 million.
Article 29, in violation of article 11 of this approach, is corrected by the management responsible for the surveillance of food medicines at the location and fines of up to 2,000 dollars.
Article 31, in violation of article 14 of this approach, has been entrusted with the production of medical equipment by other units without the approval of the Ministry's Food Medicine Monitoring Administration, which oversees the destruction of criminal preparations and imposes a fine of up to $20,000.
In violation of article 15 of this approach, the management responsible for the supervision of food medicines at the location is corrected and fines of more than 1,000 million dollars.
Article III, in violation of article 16, paragraph 2, and paragraph 3, of this scheme, provides that reports to the management of the food medicine surveillance at the location are not reported on in a timely manner and are warned by the authorities for the surveillance of food medicines at the location and fined by more than 1000 dollars.
In violation of article 17 of this approach, the management responsible for the surveillance of food medicines at the location is corrected and fines of up to 50,000 dollars.
Article 34, in violation of this approach, provides for the acquisition or use of medical equipment that is not in compliance with the registration standards, to be supervised by the host food medicine surveillance management and to fines up to $200,000.
Article 33 XV, in violation of other acts under this scheme, provides for penalties under the law.
Article 36, staff of the Food Drugs Monitoring Administration and other executive departments, abuse of authority in the use of supervision in medical institutions for medicines and medical equipment, in favour of private fraud, incentivism, and incentives, are governed by the law by their units or superior authorities, and the transfer of suspected offences to the judicial body.
Article 37