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Shenyang City's Drug And Medical Device Regulatory Approach

Original Language Title: 沈阳市药品和医疗器械监督管理办法

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(Summit 5th ordinary meeting of the People's Government of Shenung on 2 June 2008 to consider the adoption of the Ordinance No. 4 of 30 June 2008 No. 4 of the People's Government Order No. 4 of the Shen positive City, effective 1 August 2008)

In order to strengthen the management of medicines and medical equipment, the safety of human use of medicines and medical equipment is effective, and in accordance with the laws, regulations, such as the People's Republic of China's Drug Management Act, the State Department's Medical Asset Monitoring Regulation Regulations, this approach is developed in conjunction with the current city.
Article 2
Article 3 is responsible for the management of drug and medical equipment within the city's administration.
The relevant authorities at all levels are responsible for the supervision of medicines and medical equipment within their respective responsibilities.
Article IV. Purchasing and obtaining pharmacies of raw materials by pharmaceutical-producing enterprises (hereinafter referred to as pharmacies), the following documents should be requested by the supplying units and the deposit of one year after the expiry of the period of effectiveness of the pharmacies and pharmacies with pharmacies; the period of invalidity shall be retained for three years:
(i) Complete copies of the Pharmaceutical Production Permit or the pharmaceutical operation licence;
(ii) A copy of the Business Licence, which is attached to the original chapter of the Géguélication;
(iii) The Guidelines for the Quality of Medicine Production, or the certified copies of the Guidelines for the Quality Management of Medicines;
(iv) Authorization letters of approval signed by the statutory representative of the supplier or chapter (the authorization should contain the type, geographical, time frames authorized for sale, the identification number of the salesr; the authorization to be a copy of the record shall be added to the seal or signature of the original name of the supplier unit and the enterprise legal representative);
(v) A copy of the owner's identity card;
(vi) Approval of the sale of pharmaceuticals in the form of the pre-seditoral chapter of the Géguétat;
(vii) Invoices for quality of medicines, testing reports and acquisition of medicines;
(viii) Other relevant documentation to be requested by law.
Article 5
(i) To purchase pharmacies and pharmacies from enterprises that do not possess the production of medicines;
(ii) The use of pharmacies and pharmacies for raw materials that are not identified for an effective period or exceed the period of effectiveness;
(iii) pharmacies and pharmacies that do not meet legal, regulatory provisions and national mandatory standards will be produced;
(iv) The use of pharmacies and pharmacies that should be approved without approval.
Article 6.
Article 7. Medicines produced by a pharmaceutical production enterprise must be certified by a competent party.
A pharmaceutical-producing enterprise shall not forfeiture the prequalification documents for medicines such as the testing report.
Article 8
(i) To purchase medicines from retail companies of medicines;
(ii) The acquisition or sale of medical equipment;
(iii) Removal of the way in which drugs operate;
(iv) The operation of medicines beyond the scope of the pharmaceutical licence;
(v) Other commodities other than pharmaceutical counters, drug loads, etc.;
(vi) The retailer of medicines, the borrowing of a licence for the operation of medicines, and the transfer of the same medicines in different counters in the place of operation or cargo;
(vii) To grant pharmacies or opioids in various ways.
Article 9. The tools used by the retailer of medicines for the sale of medicines should be fully, clean and sanitation, and the sale of drugs should be made available in the drug packaging kits, specifications, kits, uniforms, use, effective periods.
Article 10
The production of medicines, the operation of enterprises shall not be able to store or sell medicines outside the facilities approved by the Food Drugs Monitoring Administration.
Article 11 provides for testing or clearance of approved medicines without inspection or approval, and no unit or person shall be sold or imported.
Article 12. The production of medicines, the acquisition of obsolete medicines by the operation of the enterprise shall be reported to the food drug surveillance management by 7 years of the purchase of medicines, and under the supervision of the food medicine surveillance authorities.
The illicit acquisition of medicines is prohibited.
Article 13. Medical equipment for the production of licensed medical equipment by a manufacturer and, when purchasing raw materials or parts, the following documents shall be requested to the supply unit:
(i) A copy of the Business Licence, which is attached to the original chapter of the Géguélication;
(ii) The quality of the product and the acquisition of invoices.
The raw materials or components are included in the medical equipment to be administered and are in accordance with the preceding paragraph, and should also be requested to include a copy of the “Energy for the production of the medical equipment” or “Asss for the operation of the medical equipment” or a copy of the medical equipment registration certificate, which is attached to the original chapter of the GPS.
The above-mentioned raw materials or parts are not bacterial products, demonstrating that the documents should be kept for one year after the expiry of the product's effective expiry; that there should be no effective period of time to be preserved or discontinued for three years after the sale of products; and that the document should be permanently preserved.
Article 14.
The medical weapon description, labelling, packaging marking should be consistent with the relevant elements of the medical weapon registration certificate.
Article 15. The production of medical equipment, the operation of an enterprise shall not operate medical equipment in unauthorized places of operation, nor shall medical equipment be stored in unauthorized warehouses.
Article 16 should establish the following management system:
(i) The acquisition of medicines and medical equipment;
(ii) Drugs and medical equipment from and from bank review;
(iii) Report on the quality of medicines and medical equipment, as well as monitoring and reporting on adverse responses (incidences);
(iv) Redeployment, review and maintenance of medicines;
(v) Effective drug control;
(vi) The distribution, maintenance and use of the agent;
(vii) Use and maintenance of medical equipment;
(viii) Quality tracking of intrusive medical equipment;
(ix) A one-time use of unbranted medical devices.
Article 17
The facilities, facilities and conditions for the storage of medical equipment should be in line with the standards for the quality of the products of the medical equipment.
Article 18
(i) Procurement of medicines from enterprises that do not possess the manufacture of medicines;
(ii) Procurement of medicines from pharmaceutical retail enterprises;
(iii) The use of medicines by side;
(iv) The unauthorized use of other medical institutions;
(v) To purchase medical equipment from enterprises that do not have production, operational qualifications or to purchase medical equipment free of the medical certificate;
(vi) To receive and use medical devices that have expired, invalidated or non-medical weapons registration certificates, non-qualified certificates, unpurchased invoices for the application of licence management;
(vii) Removal of medical equipment from plant standards;
(viii) Authorize processing agents by other medical agencies.
Article 19 Advertising and promoting the dissemination of written statements and accompanying drug labels, notes, packagings, or functional axes, shall not exceed the scope of national drug standards.
Article 20 Non-drug advertisements and promotion of written statements and accompanying labels, notes, packagings, etc. shall not contain the content of drug adaptation, functionality, use and use.
Article 21 practitioners who produce drugs and medical equipment and operate businesses should be eligible in accordance with national provisions and should conduct regular training and training on expertise and legal knowledge.
Article 2
Persons with infectious diseases and other diseases that may be contaminated with medicines and sterilized medical equipment shall not engage in direct access to medicines and sterilization before they are treated or excluded.
Article 23. The production, operation and medical institutions in the manufacture and use of medicines should immediately cease the sale and use of false medicines, and report immediately to the food-drug surveillance management; immediately notification of the sale and use of the purchase cell should be given to the purchaser's units; and social announcements should be given to the individuals that have been sold and the initiative to recover the medicines.
The pharmaceutical-producing enterprises have found that their production is safe and likely to cause harm to human health and life safety and should make available to society information about the cessation of the sale and use of the purchasing units and consumers, the active recruitment of medicines and the reporting of the food medicine surveillance management.
Article 24, unbranted medical equipment operated by a medical company, which is inspected to be non-qualified or safely hidden, may cause harm to human health, should immediately inform the purchaser and medical institutions to stop the sale and use of the purchaser and report to the food drug surveillance management authorities; and to make social announcements available to individuals for the purpose of recovering the products.
Medical-arm-producing enterprises have found that their production of medical equipment is safely hidden and may cause harm to human health and life safety, and information should be made available to society to inform the medical agencies and consumers of the cessation of sales, to take the initiative to receive medical equipment and to report to the food-drug surveillance management.
Article 25
Article 26 Food drug surveillance authorities may be seized and seized with one of the following cases:
(i) The National Food Drugs Monitoring Administration provides for the prohibition of use;
(ii) Unauthorized production, distribution, operation, import or inspection shall be carried out without inspection;
(iii) The use of pharmacies that do not obtain approval;
(iv) The reference to adaptation or functionality beyond the specified scope;
(v) It should be noted that no period of effectiveness or modification of the period of effectiveness should be indicated;
(vi) No reference to or modification of production orders;
(vii) Continuation of operation and use over an effective period;
(viii) Package materials and containers that are directly exposed to drugs are not approved;
(ix) The unauthorized addition of opioids, anti-corruption agents, foams, correctional agents and accompanying materials;
(x) A supplemental material for the production, distribution and use of medicines is not in accordance with the drug standards;
(xi) No production of the approved production process in accordance with the criteria or in accordance with the approved criteria;
(xii) Processing without a licence;
(xiii) Excluding the production, distribution or operation of the licence;
(xiv) Production, non-production or distribution of records, in-householding or sale records, and in-householding records.
Article 27 Production and operation of pharmaceuticals, in violation of this approach, has one of the following cases, which is subject to the penalties provided by the Food Drug Control Monitoring Administration in accordance with Article 73 of the People's Republic of China Act on the Control of Drugs, Article 74, Article 75, article VIII, article VIII, article 3 of the Special Provisions of the State Department for the Strengthening of the Safety of Products, such as Food, article IV, article IV, article IV of the National Food Control Authority's Guidelines for the Control of the Control of the Illicit Drug Traffic Control, in accordance with article 35, article 40.
(i) The storage or sale of medicines outside the facilities approved by the Food Drugs Monitoring Administration;
(ii) Removal of the way in which drugs operate;
(iii) In excess of the licence to operate medicines;
(iv) The use of pharmacies and pharmacies that should be approved without approval;
(v) The inspection or approval of medicines should be inspected or authorized, while unauthorized sales or imports are not inspected or authorized;
(vi) The acquisition of obsolete medicines;
(vii) The acquisition or sale of medical equipment;
(viii) The acquisition of medicines from retail enterprises of medicines;
(ix) To purchase pharmacies and pharmacies from enterprises that do not possess the production of medicines;
(x) The retailer of medicines, the borrowing of a licence for the operation of medicines, and the seizure of the same medicine in different counters in the place of operation or cargo;
(xi) The production of medicines in accordance with the national drug standards by side and subsectors or by the production process approved by the National Food Drugs Supervision Administration;
(xii) Unqualified documentation for the sale of medicines, either by means of testing or by testing of non-qualified and fraudulent testing reports;
(xiii) The acquisition of pharmacies and pharmacies for raw materials and the failure to request and maintain the relevant documentation for the supply units;
(xiv) The use of pharmacies and pharmacies that do not mark an effective period or exceed an effective period;
(xv) The production of pharmaceuticals and pharmacies that do not meet the legal, regulatory provisions and national mandatory standards;
(xvi) The sale of medicines to units and individuals without a licence for the production of medicines, a licence for the operation of medicines, a licence for the operation of the medical institutions;
(17) To grant prescriptions or non-conventional medicines in various ways.
Article 28 Production and operation of medical equipment in contravention of this approach provides that a food drug surveillance management is punished in accordance with article 37, article 38, article 39, and article 39, of the State Department's Medical Assurance Regulation.
(i) The medical equipment produced does not meet the criteria for the approval of implementation of the medical-armed registration certificate; the medical weapon description, labelling, packaging mark, and the related content of the medical equipment registration certificate;
(ii) The storage or sale of medical equipment outside the facilities approved by the Food Drugs Monitoring Administration;
(iii) The production of licensed-managed medical-arming enterprises do not request the relevant documentation when obtaining raw materials or parts.
Article 29, in violation of this approach by medical institutions, provides for penalties under article 31 of the People's Republic of China Pharmaceutical Medicine Management Act, in accordance with article 73, article 74, and Article 8 of the People's Republic of China Pharmaceutical Equipment Regulatory Regulation, article 42 of the State Department's Medical Asset Control Regulation Regulation Regulation, and article 31 of the Medical Institutions of Excellence of the Ministry of Foreign Innin, for the use of surveillance management of medicines and medical equipment:
(i) The use of medicines by side;
(ii) To receive the authorization of the process agent by other medical agencies;
(iii) To procure medicines from enterprises that do not possess the production of medicines and do so;
(iv) The procurement of medicines from retail companies of medicines;
(v) The unauthorized use of other medical institutions;
(vi) The acquisition of medical equipment from enterprises that do not have production, operational qualifications or the acquisition of medical equipment free of the medical certificate;
(vii) To receive, use obsolete, invalidated or unregistered evidence, non-qualified certificates, purchase invoices, and to implement medical equipment administered by a licence;
(viii) Removal of medical equipment from plant standards resulting in unqualified medical devices;
(ix) The establishment of a management system in accordance with the provisions;
(x) Maintenance of medicines and medical equipment is not in accordance with the requirements set forth.
Article 33, in violation of this approach, provides that, in accordance with Article 73 and Article 74 of the People's Republic of China Act on the Management of Pharmaceutical Medicine, the Department of State's Medical Assurance Regulation, Article 42 of the State Department's Special Provisions for the Strengthening of the Management of Products, such as Food Security, Article 9 of the National Food Drugs Supervision Authority's Guidelines for the Control of the Control of the Illicit Drug Distribution of Goods, provides penalties for:
(i) The illicit acquisition of medicines;
(ii) The use of unauthorized drugs for human beings;
(iii) Advertising and promoting the dissemination of written statements and accompanying drug labels, notes, packagings or functional axes beyond national drug standards;
(iv) Non-drug advertisements and promotion of written statements and accompanying labels, notes, packagings, etc. containing drug adaptation, functional ownership, use and content;
(v) No recovery or recruitment of medicines, medical devices, as required;
(vi) The production of medicines and medical equipment, the absence of annual expertise and legal knowledge education by business practitioners.
In violation of this approach, there are one of the following cases, which are redirected by the Food Medicine Monitoring Administration, which imposes penalties under the law:
(i) The destruction of the sale of medicines by the retailer of medicines is not in accordance with the requirements;
(ii) The production of medicines and medical equipment, and the operation of the enterprise's practitioners are not eligible in accordance with national provisions;
(iii) The production of medicines and medical equipment and the absence of a health file by persons involved in the operation;
(iv) Persons with infectious diseases and other diseases that may be contaminated with medicines and medical equipment, engaged in direct access to medicines, sterilized medical devices prior to the outbreak of disease.
Third XII, in violation of the laws, regulations and regulations governing the management of medicines, medical equipment, has one of the following cases, with severe penalties:
(i) Drugs, mental medicine, medical toxic medicines, radioactive medicines are used for other medicines, or other medicines are used for such drugs;
(ii) The production, sale of voids, disadvantages for the primary target of maternal, infant and child use;
(iii) The production, sale of biological products, blood products are treated as curatives and poor medicines;
(iv) Production, sale, use of false medicines, and poor medicines, which result in the consequences of human injury;
(v) The production, sale, use of false medicines, and the use of medicines, and treatment of recidivism;
(vi) To deny, avoid monitoring inspections, or forfeiture, destruction, conceal the material of the evidence or unauthorized seizure and seizure of the goods;
(vii) The acquisition and sale of false medicines from illegal channels;
(viii) More than three types of offences (three);
(ix) Other laws, regulations and regulations impose serious or serious consequences.
In violation of this approach, the infliction of a significant violation on the person and property of another person shall be liable under the law. Serious circumstances constitute crimes and are criminalized by the judiciary.
Article 33 is inconsistency with the administrative penalties decision, which may be applied by law for administrative review or administrative proceedings, whichever is not required for review, are not prosecuted and are not in compliance with the penalties decision, and the organs that make a penalty decision apply for enforcement by the People's Court.
Article 334 Abuse by drug supervisors, provocative fraud, negligence, constitutes criminal liability under the law, and has not been a crime, and administrative disposal is provided by law.
Article 55 of this approach was implemented effective 1 August 2008.