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TABLE OF CONTENTS CHAPTER I GENERAL PROVISIONS CHAPTER II CONDITIONS FOR APPLYING FOR OBTAINING DRUG BUSINESS LICENCE CHAPTER III THE PROCEDURES FOR APPLYING FOR OBTAINING PHARMACEUTICAL TRADE LICENCE CHAPTER IV ALTERATION AND CHANGE OF PHARMACEUTICAL TRADE LICENCE CHAPTER V SUPERVISION AND INSPECTION CHAPTER VI SUPPLEMENTARY PROVISIONS CHAPTER I GENERAL PROVISIONS Article 1. The present Measures are hereby formulated in accordance with the Pharmaceutical Administration Law of the People's Republic of China, the Regulations on the Implementation of the Pharmaceutical Administration Law of the People's Republic of China (hereinafter referred to the Pharmaceutical Administration Law, and Regulations on the Implementation of the Pharmaceutical Administration Law), for the purpose of strengthening supervision and administration on the licensing of pharmaceutical trading. Article 2. The present Measures shall be applicable to the licence issuance, change, alteration and supervision and administration on Pharmaceutical Trade Licence. Article 3. The State Food and Drug Administration shall be in charge of the work of supervision and administration on the licensing of national pharmaceutical trading. The departments of food and drug administration of the provinces, autonomous regions, and municipalities directly under the Central Government shall be responsible for the work of licence issuance, change, alteration, and routine supervision and administration on Pharmaceutical Trade Licence of pharmaceutical wholesale enterprises within their own jurisdictions, and shall direct and supervise the lower level organs of food and drug administration for their carrying out of the work of supervision and administration on Pharmaceutical Trade Licence. The organs of food and drug administration at the level of cities divided into districts or those at the county level which are set up directly by the departments of food and drug administration at the provinces, autonomous regions, and municipalities directly under the Central Government, shall be responsible for the work of licence issuance, change, alteration and routine supervision and administration on Pharmaceutical Trade Licence of drug retail enterprises within their own jurisdictions. CHAPTER II CONDITIONS FOR APPLYING FOR OBTAINING DRUG BUSINESS LICENCE Article 4. According to the provisions of Article 14 of the Pharmaceutical Administration Law, a pharmaceutical wholesale enterprise shall meet the requirements for the reasonable overall arrangement for pharmaceutical wholesale enterprises of provinces, autonomous regions, and municipalities directly under the Central Government for its establishment, and shall measure up to the following standards for establishment: (1) Having rules and regulations that can ensure the quality of drugs it manages. (2) The enterprise, the legal representative, responsible person, or the person responsible for quality control of the enterprise has no circumstances prescribed in Articles 76 and 83 of the Pharmaceutical Administration Law; (3) Having a certain number of practicing apothecaries fitting in with its business scale. The person responsible for quality control shall have a bachelor's degree or above, and shall be a practicing apothecary as well; (4) Having normal temperature warehouses, cool warehouses or refrigerators, which can ensure the quality requirements for pharmaceutical storage and can fit in with its variety and scale of business, and in which there are special goods shelves fit for pharmaceutical storage, and installations and equipment of modern logistic system for the pharmaceuticals' entering a warehouse, transmission, separate checking, putting on shelves, or leaving a warehouse. (5) Having independent computer management information system, which can cover the whole process of the pharmaceutical purchase, storage, sale, and management and quality control within the enterprise, and can record all the information on the management and implementation of the Standards for Quality Control of Pharmaceutical Trading of the enterprise; meeting the requirements of Standards for Quality Control of Pharmaceutical Trading for each process of pharmaceutical management, and having conditions for accepting supervision of the local departments or organs for food and drug administration; and (6) Having conditions meeting the requirements of the Standards for Quality Control of Pharmaceutical Trading for pharmaceutical business office, auxiliary and office buildings, and warehouse management, quality safeguards for pharmaceuticals in the warehouse, and the entry-exit of warehouse, in-warehouse storage and maintenance. Unless there are otherwise state provisions on management of stupefacient, psychotropic drugs£¬toxic drugs for medical treatment, and preventive biological produce, those provisions shall be followed. Article 5. The establishment of a pharmaceutical retail enterprise shall meet the requirements of the number of local permanent residents, regions, traffic status and actual needs, and follow the principle of convenience for the mass people to purchase pharmaceuticals, and accord with the following provisions on establishment: (1) Having rules and regulations that can ensure the quality of pharmaceuticals it manages; (2) Having pharmaceutical technical personnel whose qualifications have been certified according to law. A pharmaceutical retail enterprise, which undertakes the trading of prescriptive pharmaceuticals, or Class A non-prescriptive pharmaceuticals (OTC), shall have practicing apothecaries or other pharmaceutical technical personnel whose qualifications have been certified according to law. The person responsible for quality control shall have work experiences of quality control for pharmaceutical trading for one year or more. A pharmaceutical retail enterprise, which undertakes the trading of Class B non-prescriptive pharmaceuticals (OTC), and the pharmaceutical retail enterprises established at districts below the rural villages and towns, shall recruit business personnel in accordance with Article 15 of the Regulations on the Implementation of the Pharmaceutical Administration Law, and the practicing apothecaries shall also be recruited in case conditions permit: The foregoing personnel shall be on the job during the business hours of the enterprise; (3) The enterprise, legal representative, responsible person or person responsible for quality control of the enterprise has no circumstances prescribed in Articles 76 and 83 of the Pharmaceutical Administration Law; (4) Having the places of business, equipment, warehouse facilities and sanitary conditions fitting in with the pharmaceuticals it manages. If a retail pharmaceutical store is established in the supermarkets or within other commercial enterprises, it must have an independent area; and (5) Having abilities capable of supplying drugs that can satisfy the demand of local consumers, and ensuring the 24-hour supply. The departments of food and drug supervision and administration of all provinces, autonomous regions, and municipalities directly under the Central Government shall, in light of the specific circumstances of the local regions, determine the variety and quantity of state basic pharmaceuticals that shall be stocked by the pharmaceutical retail enterprises. Unless there are otherwise state provisions on management of stupefacient, psychotropic drugs£¬toxic drugs for medical treatment, and preventive biological produce, those provisions shall be followed. Article 6. The formulation of implementation standards for checking and accepting the establishment of pharmaceutical wholesale enterprises shall remain with the State Food and Drug Administration. The implementation standards for checking and accepting the establishment of drug retail enterprises shall be formulated by the departments of food and drug administrations of all provinces, autonomous regions and municipalities directly under the Central Government in accordance with the relevant contents of the present Measures and the Standards for Quality Control of Pharmaceutical Trading, and shall be reported to and put on records at the State Food and Drug Administration. Article 7. The business scope of the pharmaceutical trading enterprises shall be checked and ratified. The business scope of pharmaceutical trading enterprises shall cover: -stupefacient, psychotropic drugs£¬and toxic drugs for medical treatment; -Biological produce; -Chinese traditional medicinal materials; Chinese traditional medicine drink pills; Chinese patent medicines, chemical material medicines and their preparations; antibiotic material medicines and their preparations, biological and chemical medicines. Where the enterprises are to undertake pharmaceutical retail, their class of business shall be checked and ratified, the applicants' qualifications of managing the prescriptive pharmaceuticals or non-prescriptive pharmaceuticals or Class B non-prescriptive pharmaceuticals shall be determined first, and after the abovementioned has been clarified in their business scope, the specific scope of business shall be checked and ratified. The checking and ratifying of toxic drugs for medical treatment, stupefacient, psychotropic drugs, radioactive drugs and preventive biological produce shall be made in accordance with the relevant state provisions on the administration of special pharmaceuticals and preventive biological produce. CHAPTER III THE PROCEDURES FOR APPLYING FOR OBTAINING PHARMACEUTICAL TRADE LICENCE Article 8. The Pharmaceutical Trade Licence for opening a pharmaceutical wholesale enterprise shall be handled in accordance with the following procedures: (1) The applicant shall file an application for preparing to establish such an enterprise to the departments of food and drug administration at the provinces, autonomous regions, and municipalities directly under the Central Government where the enterprise to be established is located, and submit the following documents: 1. The original and photocopy of the certificate of educational backgrounds and personal resumes of the legal representatives, responsible persons, and person responsible for quality control of the enterprise to be established; 2. The original and photocopy of the certificate to practice of the practicing apothecary; 3. The scope of pharmaceuticals to be traded; and 4. The place of business, equipment, warehouse establishments to be established and the sanitary conditions around, etc.; (2) The departments of food and drug administration shall handle the applications filed by an applicant separately according to the following circumstances: 1. In case the matters applied for do not fall within the scope of the functions and powers of the corresponding departments, they shall make a decision of not acceptance, and issue the Notice of Not Acceptance, and inform the applicant to apply to the relevant departments of food and drug administration; 2. Where there is any mistake in application documents, and the mistake can be corrected on the spot, the applicant shall be permitted to correct it on the spot; 3. Where the application documents are incomplete or do not measure up to legal forms, the applicant shall be issued the Notice to Supplement the Documents on the spot or within 5 days, and be informed to supplement the whole documents needed in one time. If they fail to inform the applicant within the prescribed time limit, the date of their receiving the application documents shall be deemed as the date of acceptance; 4. Where the matters applied for fall within the scope of functions and powers of the corresponding departments, and the documents thereof are complete and in conformity with the legal form, or the applicant has submitted all the supplementary documents required, the Notice of Acceptance shall be issued to the applicant. And the date indicated in the Notice of Acceptance shall be regarded as the date of acceptance; (3) The departments of food and drug administration shall, within 30 working days from the date of accepting the application, make examination on the documents submitted in accordance with the provisions of Article 4 of the present Measures, and make decision on whether to agree with the preparation for establishment, and notify the applicants in writing. If they don't agree with the preparation for establishment, they shall explain the reason, and notify the applicants of their rights of applying for administrative reconsideration or filing an administrative litigation according to law; (4) Where, after an applicant has finished the preparation for establishment, it shall file an application for checking to the departments of food and drug administration that accept the application, and submit the following documents: 1. Application for Pharmaceutical Trade Licence; 2. Documents of approval and certification issued by the departments for industry and commerce administration for the enterprise to be established; 3. Organizations of the enterprise to be established; 4. Ground disposition plan of the places of business and warehouses, and certificates of the ownership of or right to use the houses; 5. Qualification certificates and letter of appointment of the pharmaceutical special technical personnel certified according to law; and 6. The quality control documents of the enterprise to be established and the indexes of the warehouse establishments and facilities thereof; and (5) The departments of food and drug administration accepting the application shall, within 30 working days from the date of receiving the application for checking, organize the checking according to the implementation standards for checking and accepting the establishment of pharmaceutical wholesale enterprises, make decisions on whether to issue the Pharmaceutical Trade Licence. To those enterprises meeting the requirements shall be issued the Pharmaceutical Trade Licence; and as to those not meeting the requirements, the applicants shall be notified in writing and the reason shall be explained, and they shall be informed of the rights of applying for administrative reconsideration or filing an administrative litigation according to law. Article 9. The Pharmaceutical Trade Licence for opening a pharmaceutical retail enterprise shall be handled in light of the following procedures: (1) The applicant shall file an application for preparing the establishment to the food and drug administrative organs at the level of cities divided into districts where the enterprise to be established is located or to those of the county level established directly by the departments of food and drug administration of provinces, autonomous regions, and municipalities directly under the Central Government, and submit the following documents: 1. The originals or photocopies of the educational background, qualifications to practice or certificates of title of a technical post of the legal representative, responsible person, person responsible for quality control of the enterprise to be established, and their personal resumes and qualification certificates and letter of appointment of the special technical personnel; 2. The scope of pharmaceuticals to be traded; and 3. The conditions of the place of business, warehouse facilities and equipment to be established. (2) The food and drug administrative organs shall handle the application of an applicant separately in light of the following conditions: 1. If the matters applied for do not fall within the scope of functions and powers of the corresponding departments, they shall make decision of not acceptance immediately, issue the Notice of Not Acceptance, and inform the applicant to apply to the relevant departments of food and drug administration; 2. Where there is any mistake in the application documents, and it can be corrected on the spot, the applicant shall be permitted to correct it on the spot; 3. Where the application documents are incomplete or do not measure up to the legal form, they shall issue the Notice for Supplementing the Documents to the applicants on the spot or within 5 days, and inform them of the whole contents to be supplemented in one time. If they fail to inform the applicants within the prescribed time limit, the date of receiving the application documents shall be deemed as the date of acceptance; 4. Where the matters applied for fall within the scope of functions and powers of the corresponding departments, and the documents thereof are complete and in conformity with the legal form, or the applicant has submitted all the supplementary documents required, the Notice of Acceptance shall be issued to the applicant. And the date indicated in the Notice of Acceptance shall be regarded as the date of acceptance; (3) The departments of food and drug administration shall, within 30 working days from the date of accepting the application, make examination on the documents submitted in accordance with the provisions of Article 5 of the present Measures, and make decision on whether to agree with the preparation for establishment, and notify the applicant in writing. If they don't agree with the preparation for establishment, they shall explain the reason, and notify the applicants of their rights of applying for administrative reconsideration or filing an administrative litigation according to law; (4) Where, after the applicant has finished the preparation for establishment, it shall file an application for checking to the departments of food and drug administration that accept the application, and submit the following documents: 1. Application for Pharmaceutical Trade Licence; 2. Documents of approval and certification issued by the departments for industry and commerce administration for the enterprise to be established; 3. Ground disposition plan of the places of business and warehouses, and the certificates of the ownership of or right to use the houses; 4. Qualification certificates and letter of appointment of the pharmaceutical special technical personnel certified according to law; and 5. The quality control documents of the enterprise to be established and the indexes of the warehouse establishments and facilities thereof; and (5) The food and drug administrative organs accepting the application shall, within 15 working days from the date of receiving the checking application, organize the checking according to the implementation standards for checking and accepting the establishment of pharmaceutical retail enterprises, and make decisions on whether to issue the Pharmaceutical Trade Licence. If the enterprises fail to meet the conditions, the applicants shall be notified in writing of the reason, and meanwhile shall be informed of their rights of applying for administrative reconsideration or filing an administrative litigation. Article 10. Where the departments or organs of food and drug administration find out that the matters of administrative licence of an applicant concern directly the major interests of other people when they make examination on its application, they shall notify the interested party. The acceptance departments shall hear the statement and pleadings of the applicant or the interested party. If the matters shall be dealt with through a hearing according to law, a hearing shall be held in accordance with the provisions of law. Article 11. The departments or organs of food and drug administration shall publicize the relevant information on Pharmaceutical Trade Licence they have issued, and the general public shall have the right to consult. Where, after the publicity of the information, an enterprise is found to have acts of providing false documents, data or other deceptive acts in the process of applying for the Pharmaceutical Trade Licence, it shall be punished according to law. Article 12. The Pharmaceutical Trade Licence is the legal credence of an enterprise for its undertaking of pharmaceutical trade activities, no entity or individual may forge, alter, deal, lease or lend it. CHAPTER IV ALTERATION AND CHANGE OF PHARMACEUTICAL TRADE LICENCE Article 13. The alteration of the Pharmaceutical Trade Licence shall include the alteration of the licence matters and alteration of registration matters. The alteration of licence matters refers to the alteration of the ways of management, scope of business, place of registration and warehouse (including increase or decrease of the warehouses), legal representatives, responsible person, and person responsible for quality control of the enterprise. The alteration of registration matters refers to alteration on matters not mentioned in the above-mentioned paragraph. Article 14. Where a pharmaceutical trading enterprise alters the licence matters concerning the Pharmaceutical Trade Licence, it shall apply for alteration registration on Pharmaceutical Trade Licence to the original licence issuing organs 30 days before the alteration of the former licence matters. And no licence matters shall be altered without approval. The original licence issuing organs shall, within 15 working days from the date of receiving the application for enterprise alteration and alteration of the application documents, make a decision on whether to grant the alteration. In case an enterprise applies for alteration of the licence matters, the original licence issuing departments may not handle the formalities for alteration until they have checked and accepted the enterprise and confirmed its eligibility in accordance with the conditions as prescribed in the present Measures. Where, after a pharmaceutical trading enterprise has made alteration on the licence matters concerning the Pharmaceutical Trade Licence, it shall go through the relevant alteration formalities for enterprise registration to the departments for industry and commerce administration according to law. In case an enterprise divides, merges, or changes its ways of management, or transfers exceeding the former jurisdictions, its Pharmaceutical Trade Licence shall be handled anew in accordance with the provisions of the present Measures. Article 15. Where a non-legal person branch of an enterprise legal person alters the licence matters of the Pharmaceutical Trade Licence, it shall show the alteration application with the opinions of the upper level legal person signed therein. Article 16. Where an enterprise is put on records and investigated into by the departments or organs of food and drug administration for illegal operation, and the case has not been concluded yet; or a decision of administrative punishment has been made but the punishment has not been executed, the licence issuing organs shall suspend the acceptance of its application for alteration of the Pharmaceutical Trade Licence. Article 17. Where a pharmaceutical trading enterprise alters the registration matters of the Pharmaceutical Trade Licence, it shall, within 30 days after the alteration has been approved by the departments for industry and commerce administration, apply for alteration registration on the Pharmaceutical Trade Licence to the original licence issuing organs, who shall then handle alteration formalities for it within 15 working days from the date of receiving the application for enterprise alteration and alteration application documents. Article 18. After the registration matters of the Pharmaceutical Trade Licence have been altered, the original licence issuing organs shall record the contents and time for alteration in the duplicate of the Pharmaceutical Trade Licence, and change and issue anew the original copy of the Pharmaceutical Trade Licence according to the contents altered, and take back the original copy of the Pharmaceutical Trade Licence. The period of validity of the altered Pharmaceutical Trade Licence shall remain unchanged. Article 19. The period of validity of the Pharmaceutical Trade Licence shall be 5 years. If the licence holding enterprises need to continue the trading of pharmaceuticals at the expiration of the period of validity, they shall apply to the original licence issuing enterprises for changing and reissuing the Pharmaceutical Trade Licence within 6 months before the expiration of the period of validity. The original licence issuing organs shall make examination according to the conditions for application and establishment prescribed in the present Measures. If the requirements are met, they shall take back the original licence and change and reissue a new licence. If the requirements are not met, they shall order the enterprises to rectify within a time limit of three months. And if the requirements are still not met after the rectification, the original Pharmaceutical Trade Licence shall be written off. The departments or organs of food and drug administration shall, according to the application of pharmaceutical management enterprises, make decision on whether to approve their change of licences before the expiration of the period of validity of the Pharmaceutical Trade Licence. If they fail to make decisions within the time limit, they shall be considered having approved the change of licence. CHAPTER V SUPERVISION AND INSPECTION Article 20. The departments or organs of food and drug administration shall strengthen supervision and inspection on the enterprises holding the Pharmaceutical Trade Licences. And the enterprises holding the licences shall accept the supervision and inspection according to the provisions of the present Measures. Article 21. The contents of supervision and inspection shall mainly include: (1) The name of the enterprise, business address, place of warehouses, legal representative or responsible person of the enterprise, person responsible for quality control, ways of management, scope of business, the branches, and the implementation and alteration of other important matters concerned; (2) The alteration of the business establishments and equipment of the enterprise and the warehouses conditions; (3) The implementation of the Standards for Quality Control of Pharmaceutical Trading by the enterprise; and (4) Other relevant matters that the licence issuing organs need to examine. Article 22. The supervision and inspection may be made by ways of inspection in written forms, on-the-spot inspection or the combination of the two ways: (1) The licence issuing organs may require the licence holding enterprises to submit the relevant documents of the Pharmaceutical Trade Licence, and perform their supervision functions through checking the relevant documents; (2) The licence issuing organs may make an on-the-spot inspection on the enterprises holding the licence. In case an enterprise is under any of the following circumstances, it shall be examined on the spot: (1) Newly established enterprises in the last year; (2) Enterprises having problems in the inspection of the last year; (3) Enterprises being imposed upon an administrative punishment for violating the relevant laws and regulations; or (4) Enterprises that should be examined on the spot believed by the licence issuing organs. The work for supervision and inspection and examination on licence alteration may be carried out together in the year of changing the Pharmaceutical Trade Licence. Article 23. The standards for on-the-spot inspection on Pharmaceutical Trade Licence shall be formulated by the licence issuing organs in accordance with the implementation standards for checking and accepting the establishment of pharmaceutical wholesale enterprises and those of pharmaceutical retail enterprises, and the certification and inspection standards of the Standards for Quality Control of Pharmaceutical Trading, as well as the items for on-the-spot inspection, and shall be reported to and put on records at the upper level departments or organs of food and drug administration. Article 24. If any business enterprise is found to have violated the requirements of the Standards for Quality Control of Pharmaceutical Trading in the supervision and inspection, the licence issuing organs shall order it to rectify within a prescribed time limit. If an enterprise violates the provisions of Article 16 of the Pharmaceutical Administration Law, and still fails to meet the requirements for undertaking the pharmaceutical business activities after rectification, it shall be punished according to the provisions of Article 79 of the Pharmaceutical Administration Law. Article 25. Where a licence issuing organ makes supervision and inspection on pharmaceutical trading enterprises according to law, it shall record the conditions of supervision and inspection and the conclusions of disposal, and put the records on archives after they have been signed by the supervisors and inspectors. The general public shall have the right to consult the relevant records on supervision and inspection. And the licence issuing organs shall record the conclusions for on-the-spot inspection on the duplicate of the Pharmaceutical Trade Licence and publicize them. Article 26. Under any of the following circumstances, the Pharmaceutical Trade Licence shall be written off by the original licence issuing organs: (1) The Pharmaceutical Trade Licence fails to be changed at the expiration of its period of validity; (2) The pharmaceutical trading enterprise terminates the management of drugs or is closed down; (3) The Pharmaceutical Trade Licence is revoked, withdrawn, suspended, taken back, written off or invalidated; (4) The licence matters of the Pharmaceutical Trade Licence fail to be implemented due to force majeure; or (5) Other circumstances that the administrative licence shall be written off prescribed by laws and regulations. In case the departments or organs of food and drug administration write off the Pharmaceutical Trade Licence, they shall notify the relevant departments for industry and commerce within 5 working days from the date of writing it off. Article 27. The Pharmaceutical Trade Licence shall include the original copies and duplicate copies, which shall have the same legal force. Article 28. The licence issuing organs shall establish archives for the licence issuance, change, supervision and inspection, or alteration of the Pharmaceutical Trade Licence, and report the conditions for licence issuance and alteration of the Pharmaceutical Trade Licence to the departments or organs of the upper level food and drug administration in the first month of every quarter. The Pharmaceutical Trade Licences taken back or cancelled due to alteration, change of licence, suspension, or revocation shall be kept in archives for 5 years. Article 29. In case an enterprise loses its Pharmaceutical Trade Licence, it shall report to the licence issuing organs immediately, and publish statement of loss in the media designated by the licence issuing organs. The licence issuing organs shall reissue the Pharmaceutical Trade Licence on the basis of the originally approved matters after one month from the date the enterprise publishes the statement of loss. Article 30. Where an enterprise terminates its management on drugs or is closed down, its Pharmaceutical Trade Licence shall be revoked by the original licence issuing organs. If to suspend or write off or revoke the Pharmaceutical Trade Licence, the licence issuing organs shall notify the departments for industry and commerce administration and publicize it to the public. Article 31. The original copy of the Pharmaceutical Trade Licence shall be put an eye-catching place of the business office of an enterprise. CHAPTER VI SUPPLEMENTARY PROVISIONS Article 32. The Pharmaceutical Trade Licence shall specify the names, legal representative or responsible person of an enterprise, its ways of management, scope of business, place of registration and warehouses thereof, the certificate number, current number, licence issuing department, date of issuance, and period of validity of the Pharmaceutical Trade Licence, and other items. The formulation of the patterns of original or duplicate of the Pharmaceutical Trade Licence, method of number compilation thereof shall remain with the State Food and Drug Administration uniformly. Article 33. The Pharmaceutical Trade Licence shall be formulated uniformly by the State Food and Drug Administration. Article 34. The present Measures shall be implemented as of April 1, 2004. |
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