2. To apply for the "Drug License", "Medical Device License", and then have to do business license, tax registration certificate, health license, health certificate.
If it is in the city to open the pharmacy will have these conditions:
1. Business premises of not less than 40 square meters, warehouse of not less than 20 square meters. There should be at least one resident pharmacist, a salesman (to high school or pharmacy-related graduates or after the drug regulatory department to obtain a license personnel).
2. To apply for the "Drug License", "Medical Device License", and then have to do business license, tax registration certificate, health license, health certificate.
The new pharmacy should also implement the GSP certification, GSP means: pharmaceutical quality management, everything should be operated in accordance with the GSP model.
Approval depends on how much money you send to determine
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Drug business quality management standard certification (GSP), health license, drug business license.
If you want to operate health care products, you also need to have Food and Drug Administration License
According to the "Drug Administration Law", the opening of the drug business enterprise, must have the following conditions: (1) with the qualification of pharmacy technicians according to the law; (2) with the drugs operated in the appropriate business premises, equipment, warehousing facilities, Health environment; (3) with the operation of the drugs appropriate quality management organization or personnel; (4) with the operation of drug quality assurance regulations.
When applying for the opening of a pharmacy, you should apply to the municipal drug supervision and management organization or the county-level drug supervision and management organization directly set up by the people's *** drug supervision and management department of the province, autonomous region or municipality directly under the Central Government. After applying for the "drug business license", then to the administrative department for industry and commerce for registration.
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Attachment: I. License Content "Drug Operation License" (Retail) II. Laws and regulations to set the license based on (a) The People's Republic of China **** and State Drug Administration Law", "Chinese People's *** and State Drug Administration Law Implementation Regulations" (2) "Drug Administration Quality Management Standards", "Drug Administration Quality Management Standards Implementation Rules" (3) "Drug Administration License Management Measures" Third, the license conditions (a) the legal representative or the person in charge of the enterprise, the person in charge of quality management of the enterprise does not have "Drug Administration Law", Article 76, Article 83 of the circumstances specified; (B) has been recognized in accordance with the law of pharmacy technicians; of which, set up in urban areas of retail pharmacies, must be equipped with two pharmacist title or higher pharmacy technicians, of which one as the person in charge of quality; set up in towns and villages of retail pharmacies must be equipped with 1 of the pharmacy technicians. (C) with the operation of drugs appropriate business premises, equipment, storage facilities, sanitation; of which, the urban area of the retail pharmacy business premises area of not less than 40 square meters. Town retail pharmacy business area of not less than 30 square meters, the village retail pharmacy business area of not less than 20 square meters. (D) has to ensure the quality of the drugs operated by the rules and regulations; (E) has to ensure the quality of the drugs operated by the rules and regulations; (F) in line with the requirements of the GSP. Fourth, the licensing process (a) application for construction applicants to the acceptance window to submit application materials for construction ---- acceptance ---- Municipal Food and Drug Administration to review and issue comments ---- window to receive the approval results (b) application for acceptance applicants have completed the construction of the applicant to the acceptance window to submit acceptance application materials ---- acceptance ---- Municipal Food and Drug Administration to organize the inspection of the ----- Municipal Food and Drug Administration to review ----- window to receive the approval results. Drug Administration review ---- window to receive the approval results V. Application materials (a) application for preparations for the establishment of the applicant to the Municipal Food and Drug Administration to submit applications for preparations for the establishment of the applicant, and submit the following materials: (a) 1, start-up application report. Description of the basic situation of the applicant, the reason for starting, the nature of the enterprise, business address, scope, staffing, equipment, facilities and so on. 2, the administrative department for industry and commerce issued by the new business ...... >>
Question 2: What are the conditions needed to open a pharmacy, how to handle? In general, the investment to open a pharmacy procedures are more troublesome, in addition to the need to go to do business license, tax registration certificate, health license, health certificate, etc. In addition, you also need to "drug business license", "medical equipment business license" and so on. And drug retail stores have a lot of hardware and software requirements, mainly hardware housing equipment, etc., software is mainly professional pharmacist license, previously one person, now to two pharmacist license. Subsequently, you can go to the location of the drug supervision department to apply for a drug business license, and then to the business tax and other departments to go through the relevant procedures, the main difficulty is in the Drug Administration there, if you do not have acquaintances there is very difficult to pass; the amount of investment varies depending on the situation, my side of the general will be in the 100,000 or so.
Here are some details:
1. Business premises of not less than 20 square meters, (the countryside of the pharmacy does not require a warehouse). There must be at least one resident pharmacist, a salesman (to be above high school or pharmacy-related graduates or after the drug supervision department to obtain a license personnel).
2. To apply for the "drug license", "medical device license", and then have to do business license, tax registration certificate, health license, health certificate.
If it is in the city to open the pharmacy to have these conditions:
1. Business site of not less than 40 square meters, warehouse of not less than 20 square meters. There should be at least one resident pharmacist, a salesman (to be above high school or pharmacy-related graduates or after the drug supervision department to obtain a certificate of personnel).
2. To apply for the "Drug License", "Medical Device License", and then have to do business license, tax registration certificate, health license, health certificate.
The new pharmacy should also implement the GSP certification, GSP means: the quality management of drug business, everything should be operated in accordance with the GSP model.
According to the "Drug Administration Law" provides that the opening of the pharmaceutical business, must have the following conditions: (1) with the qualification of pharmacy technicians according to law; (2) with the operation of the drugs appropriate business premises, equipment, storage facilities, sanitation; (3) with the operation of the drugs appropriate quality management organization or personnel; (4) with the operation of the quality of drugs to ensure that the regulations.
Application for the opening of a new business.
When applying for the opening of a pharmacy, you should apply to the municipal drug supervision and management organization or the county drug supervision and management organization directly set up by the people's *** drug supervision and management department of the province, autonomous region or municipality directly under the Central Government. After applying for the "drug business license", then to the administrative department for industry and commerce for registration.
Franchise chain stores also have to go through the above procedures; just use the signboard of the La Chain Store.
Due to different geographical specific amount I suggest you to the local government center drug supervision window (or Drug Administration) consultation, request information, understand the procedure, the key is to ask for the "Pharmacy Acceptance Criteria", to see whether they can meet.
Finally, we recommend that you look into the local pharmacy business situation.
I wish you success!
Question 3: What formalities are required to open a pharmacy According to the provisions of the Drug Administration Law, the opening of a pharmaceutical retail enterprise to meet the requirements of the three main aspects:
Personnel, hardware and software.
Personnel: there should be pharmacy professionals, the specific conditions depend on the proposed opening of the pharmacy is in the county above the region or in the township or village, the region may not be the same conditions, which depends on the location of the provincial Drug Administration specific provisions:
Explanation: there should be a pharmacy technician, the requirements of the county above the area of the qualification of practicing pharmacists, in the county below the level of the practitioner may be Pharmacist and secondary school graduates of pharmacy and related professions with more than two years of work experience. In the provinces, there may still be some differences.
Hardware: there must be a fixed pharmaceutical premises, it should be able to comply with the storage of drugs, does not affect the quality of drugs, and is conducive to carrying out pharmaceutical business activities in general conditions, in different areas of the premises may not be the same area requirements;
Interpretation: the general area of more than 80 square meters at the county level, the warehouse area of not less than 30 square meters. County below the principle of 40 square meters of business premises, warehouses for 20 square meters, but in the last year, the National Bureau of rural pharmacy business premises have some relaxation, the requirements of 20 square meters or more, can meet the requirements of the phase of the local business can be.
Software: must be developed in line with the provisions of the work system and management system, the specific requirements of the main reference to the GSP (Good Manufacturing Practice) provisions, and can conscientiously implement these work preparations, to do with the evidence or can be checked (i.e., the implementation of the system should be recorded).
In addition to the above conditions, the opening of a pharmacy to do procedures to prepare the materials are:
First, the legal representative of the proposed business, the person in charge of the enterprise, the person in charge of the quality of education, practice qualifications or professional title certificate original, copies and biographical information (schooling and work), the applicant is a legal person or other organizations need to provide a copy of the business license and so on; the applicant is a natural person need to provide a social A copy of the identity card.
Second, the scope of the proposed business drugs;
Third, the proposed business premises, warehousing facilities, equipment;
Fourth, it seems to set up a business premises, warehouses, the relevant departments (Civil Affairs Bureau below the Office of Geographic Names and Districts) approved by the number of the door;
Fifth, the applicant's contact information;
Sixth, the drug supervision and management departments that need to provide other materials. Other materials that the drug regulatory authorities think need to be provided.
Note: Provincial and municipal places are different, there will be some differences in requirements. However, the materials required are more stringent than other types of stores to be exact. Pharmacy has always been a more strictly regulated industry.
The following is a *** formulated to open the pharmacy need to handle the formalities stipulated:
The opening of the drug retail business in accordance with the following procedures for the "Drug License"
(a) the applicant to the proposed enterprise county food and drug supervision and management agencies to make preparations for the construction of the application, and submit the following materials:
1. the proposed enterprise's legal representative, The person in charge of the enterprise, the quality of the person in charge of the academic qualifications, practicing qualifications or professional title of the original, a copy of the certificate and personal resume and professional and technical personnel qualification certificates, letters of appointment;
2. The scope of the proposed business drugs;
3. Proposed place of business, warehousing facilities, equipment.
(b) Food and Drug Administration on the application of the applicant, the application belongs to the department's terms of reference, the materials are complete, in accordance with the statutory form, or the applicant is required to submit all the corrective materials, issued to the applicant, "Acceptance of the notice". Acceptance of the date specified in the notice of acceptance is the date of acceptance.
(C) Drug Administration acceptance of the application for review of the materials declared, make a decision on whether to agree to the preparatory work, and notify the applicant in writing.
(D) the applicant to complete the preparatory work, to accept the application of food and drug supervision and management agencies to submit an application for acceptance, and submit the following materials:
1. Drug license application form;
2. Business administration department issued by the proposed business approval documents;
3. business premises, warehouse layout and housing ownership or Proof of ownership or right to use;
4. Qualification certificates of pharmacy professionals and technicians recognized by the qualification according to law;
5. Proposed enterprise quality management documents and the main facilities, equipment catalog.
(E) acceptance of the application of food and drug supervision and management agencies in the receipt of validation applications, based on the implementation of acceptance criteria for the establishment of pharmaceutical retail enterprises to organize acceptance, to make a decision on whether to issue the "drug license". Does not meet the conditions, should be notified in writing to the applicant and explain the reasons.
When these procedures are completed, you to the location of the municipal Drug Administration written application, the Drug Administration accepts the application will be issued to you after the project notice, then you can formally prepare for the construction of the ready to apply in writing for acceptance, the Drug Administration will be organized to carry out on-site inspection and acceptance of personnel, through the will be given to you to issue the "drug business license ...... >>
Question 4: The procedures for opening a pharmacy, step by step, where to apply? 1. Business site of not less than 20 square meters, (the countryside of the pharmacy is not required to have a warehouse). There should be at least one resident pharmacist, a salesman (to high school or pharmacy-related graduates or after the drug supervision department to obtain a license personnel).
2. To apply for the "Drug License", "Medical Device License", and then have to do business license, tax registration certificate, health license, health certificate.
If it is in the city to open the pharmacy will have these pieces:
1. Business premises of not less than 40 square meters, the warehouse of not less than 20 square meters. There should be at least one resident pharmacist, a salesman (to high school or pharmacy-related graduates or after the drug regulatory department to obtain a license personnel).
2. To apply for the "Drug License", "Medical Device License", and then have to do business license, tax registration certificate, health license, health certificate.
The new pharmacy should also implement the GSP certification, GSP means: pharmaceutical quality management, everything should be operated in accordance with the GSP model.
Question 5: What formalities are required to open a pharmacy 1. Business premises of not less than 20 square meters, (countryside pharmacies are not required to have a warehouse). There should be at least one resident pharmacist, a salesman (to high school or pharmacy-related graduates or after the drug supervision department to obtain a license personnel).
2. To apply for the "Drug License", "Medical Device License", and then have to do business license, tax registration certificate, health license, health certificate.
If it is in the city to open the pharmacy to have these conditions:
1. Business premises of not less than 40 square meters, warehouse of not less than 20 square meters. There should be at least one resident pharmacist, a salesman (to high school or pharmacy-related graduates or after the drug regulatory department to obtain a license personnel).
2. To apply for the "Drug License", "Medical Device License", and then have to do business license, tax registration certificate, health license, health certificate.
The new pharmacy should also implement the GSP certification, GSP means: pharmaceutical quality management, everything should be operated in accordance with the GSP model.
The approval of the terrier depends on how much money you send to determine
Question 6: What formalities are required for individuals to open a pharmacy The following information for reference for the network --------- The newly revised "Chinese People's **** and the State Drug Administration Law" stipulates that: Whether it is an individual or a unit of the organization, the opening of the drug business operations must have the following conditions: First, with a qualification through the qualification of the pharmacy according to law. Technical personnel; second, with the operation of drugs appropriate business premises, equipment, storage facilities, sanitation; third, with the operation of drugs appropriate quality management organization and its managers; fourth, with the operation of drugs to ensure the quality of the rules and regulations. When applying for the opening of a pharmacy, you should apply to the local municipal drug supervision and management agencies or provinces, autonomous regions and municipalities directly under the Central People's *** drug supervision and management department directly set up by the county-level drug supervision and management agencies. Apply to the "drug license", and then to the administrative department for industry and commerce for registration. 1. Business premises of not less than 20 square meters, (the countryside of the pharmacy is not required to have a warehouse). At least one resident pharmacist, a salesman (to high school or more or related to pharmacy graduates or after the drug supervision department to obtain the examination of the personnel on the certificate).2. To apply for "Drug License", >, and then should also go to do business license, tax registration certificate, health permit, health certificate. If it is in the city to open the pharmacy should have these conditions: 1. business premises of not less than 40 square meters, warehouse of not less than 20 square meters. At least enamel has a resident pharmacist, a salesman (to high school or more or related to pharmacy graduates or through the drug supervision department to obtain the assessment of the personnel on the certificate).2. To apply for the "drug license", >, and then should also go to do business license, tax registration certificate, health permit, health certificate. The new pharmacy should also implement the GSP certification, GSP that means: drug business quality management, everything should be operated in accordance with the GSP model. Can open, the procedure than the establishment of an ordinary company more requirements, to go to the provincial office for "drug licensing business" and other pre-approval to the local Trade and Industry Bureau for business registration.
Question 7: What procedures do I need to do to open a pharmacy? Changchun citizen Mr. Yang asked: he wanted to open a pharmacy, but do not know where to go for the relevant procedures? Jilin Bureau of Industry and Commerce staff replied: First of all, Mr. Yang to the prospective drugstore in the district of the Bureau of Industry and Commerce application, verification of the name of the upcoming opening of the drugstore. Then go to Changchun City Drug Administration market for drug distribution license. After the license, then return to the Bureau of Industry and Commerce to apply for a business license. chinajilin/... .9 What are the procedures for opening a pharmacy? (2003-09-30 09:36:16) Mr. Zhao, Linfen: The pharmacies here seem to be doing very good business, and I have heard that the state has liberalized the policy of opening pharmacies for individuals, and I am just an ordinary citizen, and I don't have any background in the pharmaceutical industry, so can I open a pharmacy? May I ask what procedures should be done to invest in a pharmacy? Entrepreneur: In fact, there has been no restriction on the operation of individual pharmacies, pharmacy business has been opened to individuals as early as 1998, and there are currently individually operated pharmacies in all provinces of the country. However, the policy tendency for individuals to invest in opening a pharmacy varies greatly from place to place, and you'd better consult with the local drug supervision and management organization. The amount of investment to open a pharmacy is relatively large, for example, the start-up capital for a store of 80 square meters should be 200,000-300,000 RMB. Individuals investing in opening a pharmacy should also consider the scale of operation according to their own financial situation. According to the Drug Administration Law, to start a pharmaceutical business, you must have the following conditions: (1) have a qualified pharmacy technician according to the law; (2) have a business place, equipment, storage facilities, sanitary environment that is suitable for the medicines being operated; (3) have a quality management organization or personnel that is suitable for the medicines being operated; and (4) have a system of regulations that ensures the quality of the medicines being operated. When applying for the opening of a pharmacy, you should apply to the municipal drug supervision and management organization in your location or the county-level drug supervision and management organization directly set up by the people's *** drug supervision and management department of the province, autonomous region or municipality directly under the central government. After applying for the "drug business license", and then to the administrative department for industry and commerce for registration.
Question 8: the process of opening a pharmacy 1, consulting to understand the situation;
2, the proposed pharmacy practitioners enrolled in the induction training certificate;
3, the application materials to prepare;
4, the first five working days of the month to the local Food and Drug Administration to apply;
5, the local food and drug supervision and management bureau of the format and completeness of the material to carry out Review, meet the requirements of the notice of acceptance issued. Does not meet, within 5 days of the "Notice of Corrective Material";
6, county (city) Food and Drug Administration to organize on-site verification;
7, in line with the conditions of preparation, publicity for 7 days, no special circumstances, issued by the preparation of consent to the preparation of the notification; do not agree to the preparation of the reasons and inform the applicant of the right to file an administrative reconsideration or administrative litigation according to law;
8, Acceptance of the material is ready, the applicant to submit an application for acceptance of preparations;
9, 10 working days to organize on-site acceptance, the county pharmacy reported to the Municipal Food and Drug Administration acceptance (or by the Municipal Bureau entrusted to the County Council acceptance), townships and villages, village-level pharmacies by the local Food and Drug Administration to organize on-site acceptance;
10, acceptance of the qualified, to the Municipal Bureau of obtaining permits; acceptance of the unqualified. Written notice to the applicant and explain the reasons, at the same time, inform the applicant has the right to apply for administrative reconsideration or administrative litigation according to law;
11, to the administrative department for industry and commerce for business license, business;
12, within 30 days after the operation of the Food and Drug Administration in Yancheng to apply for GSP certification.
The following conditions should be met to open a pharmaceutical retail enterprise:
1, practitioners are familiar with the laws and regulations of pharmaceutical management, the legal representative of the enterprise, the person in charge, the person in charge of quality, without the "Drug Administration Law", Article 76, Article 83 of the situation;
2, the pharmaceutical retail enterprise has a good sanitation environment, equipped with facilities and equipment appropriate to the business norms.
3, drug retailers to develop rules and regulations to ensure the quality of medicines, with the ability to meet the needs of local consumers need medicines, and to ensure that 24-hour drug sales.
4, the minimum requirements of the business premises: set up in the main street of the county drug retail (chain stores) enterprises, the business area shall not be less than 100 square meters; in the townships and townships to start the business area shall not be less than 40 square meters, the village set up a drug retail enterprise business area of not less than 20 square meters; in the realization of the electronic information technology to order medicines, with a reliable supply of medicines channels, medicines can be sold to get Timely replenishment of the premise, can not have a warehouse.
5, the quality of the enterprise responsible for the minimum requirements: the county single-pharmacy should have a license (from) pharmacist qualifications, township chain stores and townships, village-level single-pharmacy should have a pharmacist above the technical title, the village chain stores can be trained to obtain the village pharmacy pharmacy practitioner certificate of qualification of high school graduates as.
6, all personnel of the pharmacy to obtain the induction training certificate.
Materials to be provided:
First, the following materials need to be submitted to the preparatory application:
1, the person in charge of the proposed enterprise ID card, proof of academic qualifications, a copy of proof of title, personal resume;
2, the proposed enterprise quality officer, professional and technical personnel of the ID card and a copy of the certificate of title, personal resume;
3, the proposed The scope of business drugs description (equivalent to the application report);
4, the proposed pharmacy geographic location map;
5, the proposed business premises, warehouse diagram (indicating the use of the area);
6, the business premises, the warehouse with the facilities and equipment situation description;
7, a copy of all the personnel of the proposed pharmacy on-the-job training certificates, the village pharmacy application Personnel in the pharmacy practitioners must provide a copy of the pharmacy practitioner certificate of competency.
8, administrative licensing (administrative confirmation) application materials to ensure the authenticity of the statement.
Second, the applicant received the notice of the project, after completing the preparatory work, the application for acceptance, the following materials to be submitted:
1, Drug License Application Review Form
2, the administrative department of industry and commerce of the pre-approval of the business name notification;
3, pharmacy geographic location;
4, the business premises, the warehouse floor plan layout;
5, building ownership certificate, rental agreement;
6, the quality of the person in charge of the employment agreement, title certificate and a copy of ID card to ensure that the in-service in-service certificate (such as: proof of retirement, proof of leaving the post, proof of pending employment, etc.);
7, the enterprise quality management system directory, the main facilities and equipment directory;
8, the pharmacy of all staff roster, health Certificate (must be in the county hospital physical examination).
9, administrative licensing (administrative confirmation) application materials to ensure the authenticity of the statement.
Third, the above application materials should be printed, copies should be clear; unified use of A4 paper; sequential coding and bound in the upper left corner; all materials in triplicate; report the materials all copies of the original must be brought together ...... >>
Question 9: What formalities are required to apply for an individual pharmacy business license First obtain permission from the local drug administration department to give you a drug license, with this certificate and then to the jurisdiction of the industry and commerce department to apply for an individual business license.