Drug Business License Management

Original Language Title: 药品经营许可证管理办法

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(February 4, 2004 the State food and drug administration released 6th) Chapter I General provisions article to strengthen the supervision and management of the drug business license, according to the People's Republic of China pharmaceutical administration law and the People's Republic of China pharmaceutical administration law implementing regulations (hereinafter referred to as the pharmaceutical administration law, the implementation of the pharmaceutical administration law regulations) relevant provisions of these measures.
    Article in the drug business license issuing, renewal, change and regulatory procedures apply.
    Third State food and drug administration responsible for drug supervision and administration of business licenses nationwide.
    Provinces, autonomous regions and municipalities (food) pharmaceutical supervisory and administrative departments shall be responsible for the area of pharmaceutical wholesale business trading license issuing, renewal, change and daily supervision and management, and directs and supervises the (food) drug regulatory authority to carry out the supervision and control of the drug supply certificate.
    City divided into districts (food) drug regulatory authority or the provinces, autonomous regions and municipalities directly under the (food) the pharmaceutical supervisory and administrative department directly at county level (food) drug regulatory agencies responsible for drug retail enterprises within their respective jurisdictions of the pharmaceutical business license issuing, renewal, change and daily supervision and management work.
    Second chapter led drug business license of conditions fourth article according to drug management method 14th article provides, opened drug wholesale enterprise, should meet province, and autonomous regions, and municipalities drug wholesale Enterprise reasonable layout of requirements, and meet following set standard: (a) has guarantee by business drug quality of regulations; (ii) enterprise, and Enterprise statutory representative people or Enterprise head, and quality management head no drug management method 76th article, and 83rd article provides of case; (C) is commensurate with the scale of a certain number of licensed pharmacists. Head of quality control have a university education, and must be licensed pharmacists; (d) to ensure drug store quality requirements, and its business and to adapt to the size of the library, cool, cold storage at room temperature. Warehouse in the has for drug store of dedicated shelf and achieved drug storage, and transfer, and points check, and last, and out library modern logistics system of device and equipment; (five) has independent of computer management information system, can cover enterprise within drug of purchased into, and store, and sales and business and quality control of full process; can full records enterprise business management and the implementation drug business quality management specification aspects of information; meet drug business quality management specification on drug business the link of requirements,
    And can implement local (food) drug regulatory agency (Agency) monitoring conditions; (f) consistent with the medicine quality control specifications for drug business establishments and support, Office space and warehouse management, warehouse and drug quality and safety guarantee and access to libraries, library storage and maintenance conditions.
    Countries on the management of narcotic drugs, psychotropic drugs, toxic drugs for medical use, preventive biological products otherwise provides, from its provisions. Fifth article opened drug retail enterprise, should meet local resident population number, and geographical, and traffic status and actual need of requirements, meet convenient masses purchased drug of principles, and meet following set provides: (a) has guarantee by business drug quality of regulations; (ii) has law after qualification finds of pharmacy technicians; business prescription drug, and methyl class non-prescription drug of drug retail enterprise, must distribution has practice industry pharmacists or other law after qualification finds of pharmacy technicians.
    In charge of quality for more than one year (including one year) work experience in medicine quality control.
    Non-prescription drugs business of b class drug retailer, as well as the rural areas of the following drugs retail enterprises, should be in accordance with the implementing regulations of the pharmaceutical administration law of 15th section equipped with operational staff, conditions should be equipped with a licensed pharmacist.
    Business hours, these personnel should be employed. (C) enterprises, the legal representative of the enterprise, business leaders, quality Director of the drug administration law of the 76th-free, 83rd article; (d) commensurate with the drugs business premises, equipment, storage facilities and a sanitary environment. In other business enterprises such as the establishment of retail pharmacies in the supermarket, you must have separate areas, (v) can be equipped with ability to meet local consumer medicines needed, and ensure 24-hour supply.
    Drug retail sales number of national essential drugs should be available from various provinces, autonomous regions and municipalities directly under the (food) in drug supervision and management departments in accordance with local circumstances.
    Countries on the management of narcotic drugs, psychotropic drugs, toxic drugs for medical use, preventive biological products otherwise provides, from its provisions. Article sixth established wholesale business acceptance criteria formulated by the State food and drug administration.
    Acceptance criteria established retail enterprises, from various provinces, autonomous regions and municipalities directly under the (food) drug supervision and management departments in accordance with this approach and the medicine quality control specifications of relevant organizations to develop, record and report to the State food and drug administration.
    Seventh business scope approved pharmaceutical trading enterprises.
    Drug-handling enterprise business: narcotic drugs, psychotropic substances, toxic drugs for medical use; biological products Chinese herbal medicine, Chinese herbal medicine and proprietary Chinese medicines, chemical raw materials and preparations, antibiotic drug substances and drug products, and bio-pharmaceuticals.
    Engaged in the pharmaceutical retail should be type approved to determine organizers engaged in prescription or over-the-counter drug, category b eligibility for non-prescription drugs, and clearly in the scope and approved business scope.
    Medical toxic drugs, narcotics, psychotropic drugs, radioactive drugs approved in accordance with the country and preventive biological products special drug management and prophylactic biological products management and the related regulations. Third chapter led drug business license of program eighth article opened drug wholesale enterprise according to following program handle drug business license: (a) bid people to proposed Enterprise location of province, and autonomous regions, and municipalities (food) drug supervision management sector proposed preparation application, and submitted following material: 1. proposed Enterprise statutory representative people, and Enterprise head, and quality head degree proved original, and copies and the personal resume; 2. practice industry pharmacists practice industry certificate original, and copies; 3. intends business drug of range; 4.
    The proposed business premises, equipment, storage facilities and the health environment and so on. (Ii) (food) drug supervision management sector on bid people proposed of application, should according to following situation respectively made processing: 1. application matters not belongs to this sector terms range of, should rates made not accepted of decided, to not accepted notice, and told bid people to about (food) drug supervision management sector application; 2. application material exists can spot corrections errors of, should allows bid people spot corrections; 3. application material not align or not meet statutory form of, Shall, on the spot or sent to the organizers of the 5th supplement notice of material, once told to correct entirety. Fails to inform the, shall be accepted as of the date of receipt of the application materials; 4. application terms of reference the matters covered in this sector, materials complete, in compliance with the statutory form, all corrections submitted documents or the applicant, issued to the applicant the notification of acceptance.
    The date indicated in the notification of acceptance for processing time. (C) the (food) the pharmaceutical supervisory and administrative department within 30 working days from the day of acceptance of the application, according to the provisions of this article fourth review application materials, make a decision on whether to agree to build and notify the applicant in writing.
    Do not agree to build, it shall explain the reasons and inform the organizers apply for administrative reconsideration or bring an administrative suit right. (Four) bid people completed preparation Hou, to accepted application of (food) drug supervision management sector proposed acceptance application, and submitted following material: 1. drug business license application table; 2. business administration sector issued of proposed Enterprise approved proved file; 3. proposed enterprise organization institutions situation; 4. business places, and warehouse plane layout figure and the housing property or right proved; 5. law after qualification finds of Pharmacy professional technicians qualification certificate and the appointment; 6. proposed enterprise quality management file and the warehouse facilities, and
    List of equipment. (V) accepting applications (for food) are received by the pharmaceutical supervisory and administrative department within 30 working days from the date of acceptance of the application, based on the establishment of pharmaceutical wholesale enterprises and acceptance criteria acceptance and make a decision on whether to issue a pharmaceutical license.
    Meet the requirements, issue a pharmaceutical license; does not meet the criteria, and shall notify the applicant in writing and state the reasons and inform applicants apply for administrative reconsideration or bring an administrative suit right. Nineth article opened drug retail enterprise according to following program handle drug business license: (a) bid people to proposed Enterprise location set district of city level (food) drug supervision management institutions or province, and autonomous regions, and municipalities (food) drug supervision management sector directly set of County (food) drug supervision management institutions proposed preparation application, and submitted following material: 1. proposed Enterprise statutory representative people, and Enterprise head, and quality head of degree, and practice industry qualification or titles proved original, and
    Copies of your resume and qualifications, professional and technical personnel appointment; 2. the intended scope of the drug; 3. business premises, storage facilities and equipment are proposed. (Ii) (food) drug supervision management institutions on bid people proposed of application, should according to following situation respectively made processing: 1. application matters not belongs to this sector terms range of, should rates made not accepted of decided, to not accepted notice, and told bid people to about (food) drug supervision management sector application; 2. application material exists can spot corrections of errors of, should allows bid people spot corrections; 3. application material not align or not meet statutory form of, Shall, on the spot or sent to the organizers of the 5th supplement notice of material, once told to correct entirety. Fails to inform that, from the date of receipt of the application materials shall be inadmissible;

    4. applications for terms of reference the matters covered in this sector, materials complete, in compliance with the statutory form, all corrections submitted documents or the applicant, issued to the applicant the notification of acceptance.
    The date indicated in the notification of acceptance for processing time. (C) the (food) drug regulatory authority within 30 working days from the day of acceptance of the application, according to the provisions of this article fifth review application materials, make a decision on whether to agree to build and notify the applicant in writing.
    Do not agree to build, it shall explain the reasons and inform the applicant legally entitled to apply for administrative reconsideration or bring an administrative suit right.
    (Four) bid people completed preparation Hou, to accepted application of (food) drug supervision management institutions proposed acceptance application, and submitted following material: 1. drug business license application table; 2. business administration sector issued of proposed Enterprise approved proved file; 3. business places, and warehouse plane layout figure and the housing property or right proved; 4. law after qualification finds of Pharmacy professional technicians qualification certificate and the appointment; 5. proposed enterprise quality management file and the main facilities, and equipment directory. (V) accepting applications (for food) are received by the drug regulatory agency within 15 working days from the date of acceptance of the application, based on established retail enterprises and acceptance criteria acceptance and make a decision on whether to issue a pharmaceutical license.
    Does not meet the criteria, and shall notify the applicant in writing and state the reasons, at the same time, inform the organizers have the right to apply for administrative reconsideration or bring an administrative lawsuit in accordance with law. Tenth (food) drug regulatory agency (Agency) to review the applicant's application and found that administrative licensing items directly related to the vital interests of others, it shall inform the interested party. Accept Department shall hear statements and pleadings of the applicant or interested party.
    The hearing according to law, hearing held in accordance with the law.
    11th (foods) the pharmaceutical supervisory and administrative departments (body) shall have been issued by the drug business related information be made public, the public's right to read.
    Publicly available information found in enterprises in the pharmaceutical business license applications, providing false documents, data or other dishonest act, should be dealt with according to law.
    12th in the drug business is engaged in pharmaceutical business activities of legal documents, any unit and individual shall forge, alter, buy, sell, lease and lend.
    The fourth chapter of the pharmaceuticals business of change and renewal of 13th drug business license change into licensing changes and change of registered particulars.
    License change is the mode of operation, scope of business, registration address, warehouse address (include changes in warehouse), the legal representative or the person in charge as well as quality changes.
    Change of registered particulars refer matters other than matters of the above changes. Article 14th trading enterprises change business licensing matters in the drug, it should be in the original license is changed before 30th, the original issuing authority for business registration in the drug.
    Without approval, and shall not change licensing matters.
    License issuing authority shall receive the enterprise change request and within 15 working days from the date on which the change request information to approve the change or not to change the decision.
    Apply for a license change, the original issuing department upon the acceptance of the conditions in accordance with this regulation, can handle the change.
    Drug-handling enterprises after change of the business license in drug matters, should register with the Administrative Department for industry and commerce enterprises registered according to law about the change.
    Enterprise Division, merger or change their mode of operation, to transfer original jurisdiction, in accordance with the provisions of this way again for the pharmaceutical business license.
    15th the unincorporated branches of an enterprise as legal person business license in changing the drug, must provide superior corporate signing application for amendment.
    16th enterprise because the illegal business have been (food) drug regulatory agency (Agency) investigation closed yet; or administrative punishment decision has been made, pending punishment, issuing body shall be suspended its drug business license application. 17th pharmaceutical trading enterprises change business registration in the drug should be approved by the Administrative Department for industry and commerce in the 30th after the change, the original issuing authority for business registration in the drug.
    License issuing authority shall receive the enterprise change request and change application information within 15 working days of the date for the change procedures. 18th the drug business registration was changed, by the original issuing authority record changes in the drug business license copy of content and timing, and press change again after the issuance of the pharmaceutical business license original, recover the original drug business license original.
    The drug business after the change license of the same. 19th the drug business license is valid for 5 years. Has expired, the continued existence of needed drugs, certified enterprises shall, within 6 months before the expiry, the original issuing authority for the renewal of the pharmaceutical business license. Original issuing authorities in accordance with these rules review of the bidding conditions, eligible to recover the original license and issue a new card.
    Does not meet the criteria, within 3 months of the rectification, rectification still does not meet the criteria of, cancellation of original pharmaceutical trading license. (Food) drug regulatory agency (Agency) under drug-handling enterprise applications should be made in the drug supply certificate before the expiry of decision on whether to grant renewal.
    Fails to make a decision, as a grant renewal.
    Chapter fifth inspection 20th (food) drug regulatory agency (agencies) should strengthen supervision and inspection of business certified enterprises in the drug, licensed enterprises shall accept supervision and inspection as provided herein.
    21st article supervision check of content main including: (a) Enterprise name, and business address, and warehouse address, and Enterprise statutory representative people (Enterprise head), and quality head, and business way, and business range, and branch institutions, important matters of implementation and changes situation; (ii) enterprise business facilities equipment and the warehouse conditions changes situation; (three) enterprise implementation drug business quality management specification situation; (four) sent card organ need review of other about matters.
    22nd control and inspection can take a written examination, inspection or written with the on-site inspection methods.
    (A) the enterprise certification authority may require the licensee to submit to the drug business related materials, by checking related materials, in discharging its oversight responsibilities, (ii) issuing authorities can make on-site inspections of certified enterprises.
    Have one of the following enterprises, conducting on-site inspections must be: 1. previous year start-up enterprises; 2. the problems existing in the last annual inspection of the enterprise; 3. violations of the relevant laws, regulations, administrative punishment of enterprises; 4. issuing authority deems it necessary to conduct on-site inspection of the enterprise.
    The drug business license renewal work that year, supervision and inspection and replacement work can be carried out together.
    23rd the pharmaceutical business license inspection standards, acceptance by the issuing authority in accordance with the established wholesale enterprise implementing standards, acceptance of established retail enterprises to implement standards and certification standards of the medicine quality control specifications and site inspection projects and newspaper level (food) drug regulatory agency (Organization) record. Article 24th of supervision and inspection were found in violation of the medicine quality control norms require business enterprises, the issuing authority shall order deadline for rectification.
    Violations of the provisions of the drug administration law of the 16th, still does not meet the requirements after rectification of drug making business activities, according to the 79th provision of the drug administration law. 25th issuing authority on drug managing enterprises according to law when conducting supervision and inspection, supervision and inspection of the circumstances and consequences should be recorded after being signed by the inspectors from the archive. The public's right to have access to the supervision and inspection of records.
    Results of on-site inspection, certification authorities shall record on the copy of the license in the drug and make an announcement.
    26th article has following case one of of, drug business license by original sent card organ cancellation: (a) drug business license validity expires not for card of; (ii) drug business enterprise terminated business drug or close of; (three) drug business license was law undo, and withdrawn, and revoked, and recovered, and hand or announced invalid of; (four) force majeure led to drug business license of license matters cannot implementation of; (five) legal, and regulations provides of should cancellation administrative license of other case.
    (Food) drug regulatory agency (Agency) cancelled the pharmaceutical business license, shall within 5 working days from the date of cancellation notice about administration of industry and commerce. 27th a pharmaceutical business including originals and copies.
    Copy of the original and has the same legal effect. 28th a releasing authority shall establish a pharmaceutical license certification, replacement, inspection, change aspects of the working files, and early in each quarter the drug business of issuing, change of the newspaper level (food) the pharmaceutical supervisory and administrative departments (authorities).
    Result of change, renewal, revocation, cancellation, recall and set aside the pharmaceutical business license should be archived for 5 years. Article 29th loss the pharmaceutical business license should be reported immediately to the issuing authority, and posted on the certification authority specifies the media declared lost.
    Issuing authority published in Enterprise declared lost after the expiration of 1 month from the date, approved by the former reissue the drugs trade license.
    Article 30th or close the termination of drugs, drug supply certificate by the issuing authority for cancellation.
    Issuing authority revocation or cancellation and the cancellation of the drug business license, shall notify the Administrative Department for industry and commerce, and to the public.
    31st the original license should be placed in the drug business premises prominently. The sixth chapter supplementary articles

    32nd pharmaceutical license shall include the company name, legal representative or business owner names, mode of operation, scope, registration address, warehouse address, the drug business license certificate number, serial number, issuing authority, date of issuance, expiration and other projects.
    The pharmaceutical business license original and replica styles, numbering, formulated by the State food and drug administration.
    Article 33rd in the drug business license uniformly printed by the State food and drug administration.
  34th article of the rules as of April 1, 2004.

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