Measures for the Administration of Pharmaceutical Trade License （2017 Amendment）

Measures for the Administration of Pharmaceutical Trade License （2017 Amendment） Measures for the Administration of Pharmaceutical Trade License (Promulgated by the Order No. 6 of the China Food and Drug Administration on February 4, 2004; and amended in accordance with the Decision to Amend Certain Rules adopted at the administrative meeting of the China Food and Drug Administration on November 7, 2017) 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 as 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 license issuance, change, alteration and supervision and administration on Pharmaceutical Trade License. Article 3 The China Food and Drug Administration shall be in charge of the work of supervision and administration on the licensing of national pharmaceutical trading. The food and drug administrative departments of the provinces, autonomous regions, and municipalities directly under the Central Government shall be responsible for the work of license issuance, change, alteration, and routine supervision and administration on Pharmaceutical Trade License of pharmaceutical wholesale enterprises within their own jurisdictions, and shall direct and supervise the lower level food and drug administrative departments for their carrying out of the work of supervision and administration on Pharmaceutical Trade License. The food and drug administrative departments at the level of cities divided into districts or those at the county level which are set up directly by the food and drug administrative departments at the provinces, autonomous regions, and municipalities directly under the Central Government, shall be responsible for the work of license issuance, change, alteration and routine supervision and administration on Pharmaceutical Trade License of drug retail enterprises within their own jurisdictions. Chapter II Conditions for Applying for Obtaining Drug Business License 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 as prescribed in Articles 75 and 82 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 refrigeratories, 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 the Standards for Quality Control of Pharmaceutical Trading for each process of pharmaceutical management, and having conditions for accepting supervision of the local food and drug administrative departments; 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; and 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 as prescribed in Articles 75 and 82 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 food and drug administrative departments 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 China Food and Drug Administration. The implementation standards for checking and accepting the establishment of drug retail enterprises shall be formulated by the food and drug administrative departments 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 China Food and Drug Administration. Article 7 The checking and ratifying of the business scope of the pharmaceutical trading enterprises: 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 above-mentioned 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 License Article 8 The Pharmaceutical Trade License for opening a pharmaceutic......