Opening a pharmacy, first of all, you must obtain a business license registered with the business sector, followed by the food and drug regulatory department to open a pharmacy personnel, systems and other requirements, such as proof of ownership of housing or housing lease contract, the enterprise legal person (person in charge) of the academic certificate and other information. To start a drug retail chain enterprise must have the following conditions:
Have rules and regulations to ensure the quality of the drugs they operate;
Enterprises, legal representatives of enterprises, the person in charge of enterprises, the person in charge of quality management, the person in charge of the quality management department do not have the situations stipulated in Articles 75 and 82 of the Drug Administration Law;
Have a certain number of licensed pharmacists. The person in charge of quality has a university degree or above, the person in charge of the quality management department has a college degree or above, a licensed pharmacist, and has a certain amount of experience in the quality management of drug business;
has a room-temperature warehouse, a cool warehouse, and a cold warehouse that can ensure the quality requirements for the storage of medicines and that is compatible with the variety and scale of its business. (except for the distribution of drugs entrusted to wholesale drug companies);
has a computerized management information system networked with each store, which can cover the whole process of purchase, storage, sale, operation and quality control of drugs in the enterprise; can comprehensively record information on business management and implementation of the "Code of Practice for the Quality Management of Pharmaceutical Business"; and is in line with the requirements of the "Code of Practice for the Quality Management of Pharmaceutical Business" for each link of the drug business. Requirements, and has the conditions can be realized to accept the local (food) drug regulatory authorities (agencies) supervision;
Have in line with the "Drug Business Quality Management Code" on drug business premises and auxiliary, office premises and warehouse management, warehouse drug quality and safety and security and entry and exit of the warehouse, in the warehouse storage and maintenance of the conditions.
Expanded information:
A drug supervision and management refers to the supervision and management of drugs in accordance with the administrative authorities Authorized by laws and regulations, in accordance with the provisions of relevant laws and regulations, the process of drug development, production, circulation and use of management.
Secondly, the Standing Committee of the Ninth National People's Congress considered and passed the newly revised Drug Administration Law of the People's Republic of China on February 28, 2001, which for the first time clarified the status of drug supervision and management departments as the main body of law enforcement.
Three, the State Food and Drug Administration is the State Council comprehensive supervision of food, health products, cosmetics safety management and in charge of drug supervision directly under the State Council, is responsible for drugs (including Chinese herbal medicines, Chinese medicine, Chinese medicine, Chinese medicine, chemical raw materials and their preparations, antibiotics, biochemical drugs, biological products, diagnostic drugs, radiopharmaceuticals, anesthesia drugs, poisonous drugs, psychotropic substances, medical devices, sanitary materials, pharmaceutical packaging materials, etc.), and the State Food and Drug Administration (SFDA). (including Chinese medicine, hygiene materials, pharmaceutical packaging materials, etc.) of the research, production, circulation, use of administrative supervision and technical supervision; responsible for food, health food, cosmetic safety management of the integrated supervision, organization and coordination and according to law to organize and carry out the investigation and handling of major accidents; responsible for the approval of health food. Its main responsibilities are:
(a) organizing the relevant departments to draft laws and administrative regulations on the safety management of food, health food and cosmetics; organizing the relevant departments to formulate comprehensive supervision policies on the safety management of food, health food and cosmetics, work planning and supervision of implementation.
(2) Exercise the comprehensive supervision of food, health food and cosmetic safety management in accordance with the law, and organize and coordinate the supervision of food, health food and cosmetic safety undertaken by the relevant departments.
(3) according to law to organize and carry out the investigation and handling of food, health food, cosmetics, major safety incidents; under the authorization of the State Council, the organization and coordination of the national food, health food, cosmetics, safety of special law enforcement and supervision activities; organization, coordination and cooperation with the relevant departments to carry out food, health food, cosmetic safety of major accidents, emergency rescue work.
(4) comprehensive coordination of food, health food, cosmetic safety testing and evaluation; in conjunction with the relevant departments to develop food, health food, cosmetic safety supervision and information dissemination methods and supervise the implementation of the integrated departments of food, health food, cosmetic safety information and regularly released to the community.
(E) drafting laws and administrative regulations on drug management and supervise the implementation; according to law, the implementation of the protection system for varieties of traditional Chinese medicine and the administrative protection system for drugs.
(6) Drafting laws and administrative regulations on the management of medical devices and supervising their implementation; responsible for the registration and supervision of medical device products; drafting relevant national standards, formulating and revising industry standards for medical device products and production quality management norms and supervising their implementation.
(VII) registers medicines, formulates, revises and promulgates national standards for medicines; formulates market access standards for health care products, and is responsible for the approval of health care foods; formulates a system for the categorization and management of prescription and non-prescription medicines, establishes and improves the system for the monitoring of adverse reactions to medicines, and is responsible for the reappraisal of medicines, the examination and approval of phased-out medicines and the formulation of a national catalog of essential medicines.
(viii) Formulating and revising quality management standards for drug research, production, circulation and use, and supervising their implementation.
(ix) Supervise the quality of medicines and medical devices in manufacturing and operating enterprises and medical institutions, and regularly issue national bulletins on the quality of medicines and medical devices; investigate and deal with the production and sale of counterfeit and inferior medicines and medical devices in accordance with the law and other violations of the law.
(10) Supervision of radiopharmaceuticals, narcotic drugs, toxic drugs, psychotropic drugs and special medicines and equipment in accordance with the law.
(k) the development and improvement of licensed pharmacists qualification access system, supervise and guide the registration of licensed pharmacists.
(xii) To direct the national supervision and management of drugs and the comprehensive supervision of the safety management of food, health food and cosmetics.
(xiii) To carry out exchanges and cooperation among governments and international organizations related to drug supervision and management and the safety management of food, health food and cosmetics.
(xiv) undertake other matters assigned by the State Council.
Baidu Encyclopedia: Supervision and Administration of Medicines