Q：
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What are the conditions for applying for Drug Production License?
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A：
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In addition to complying with the development plan and industrial policy of the drug industry formulated by the state, the application for the Drug Production License shall also meet the following conditions:
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It shall have legally qualified drug technicians, engineering technicians and corresponding technical workers;
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It shall have factory buildings, facilities and hygienic environment suitable to produce drugs;
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It shall have organization, personnel and necessary instruments and equipment capable of conducting quality management and quality inspection of the drugs produced;
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It shall have rules and regulations to ensure drug quality.
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Q：
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What materials are required for applying for Drug Production License?
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A：
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An enterprise applying for Drug Production License shall submit the following materials to the local drug supervisory and administrative department:
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Basic information of the applicant and relevant supporting documents;
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Basic information of the enterprise, including enterprise name, production variety, dosage form, equipment, process and production capacity; description of the site, surrounding environment, infrastructure and other conditions of the enterprise and the investment scale;
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Business License of the enterprise, production address and registered address, enterprise type, legal representative or person in charge of the enterprise;
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Organization chart of the enterprise (indicating the responsibilities and mutual relations of each department and the person in charge of the department);
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Resumes, educational background and professional title certificates of the legal representative, person in charge of the enterprise and person in charge of the department of the enterprise; registration form of legally qualified pharmacy and related professional and technical personnel, engineering and technical personnel, and skilled workers, indicating their departments and positions; table on the proportion of senior, intermediate and junior technical personnel;
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The surrounding environment map, general layout plan, storage layout plan, and floor plan of quality inspection place of the enterprise;
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Production process layout plan of the enterprise (including dressing room, bathroom, staff and logistics channel, air lock, etc., and indicating the direction of people and logistics and air cleanliness level), air supply, return and exhaust layout plan of air purification system, and process equipment layout plan;
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Production scope, dosage form, variety, quality standard and basis;
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Process flow chart of production dosage forms and varieties, and indicate the main quality control points and items;
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Verification overview of air purification system, water preparation system and main equipment; calibration of production and inspection instruments, meters and weighing instruments;
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Catalogue of main production equipment and inspection instruments;
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Catalogue of enterprise production management and quality management documents.
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Q：
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What should the drug production enterprise do when Drug Production License is going to expire?
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A：
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If it is necessary to continue to produce drugs after the expiration of the Drug Production License, the drug production enterprise shall apply to the original issuing authority for renewal of the Drug Production License within 6 months before the expiration of the validity.
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Q：
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What should the drug production enterprise do if Drug Production License is lost?
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A：
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If Drug Production License is lost, the drug production enterprise shall immediately apply to the original issuing authority for reissue and publish the loss statement on the media designated by the original issuing authority. The original issuing authority shall reissue the Drug Production License according to the original approved items within 10 working days after loss statement is published by the drug production enterprises for one month.
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Q：
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How to change Drug Production License?
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A：
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The change of Drug Production License is divided into the change of licensed items and the change of registration items. The change of licensed items refers to the change of the person in charge of the enterprise, production scope and production address; the change of registration items refers to the change of enterprise name, legal representative, registered address, enterprise type and other items.
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FAQ
