An enterprise dealing in drugs must meet the following conditions:
First, it has qualified pharmaceutical technicians according to law;
Second, it has business premises, equipment, storage facilities and sanitary environment suitable for the drugs it deals in;
Third, it has a quality management organization or personnel suitable for the drugs it deals in;
Fourth, there are rules and regulations to ensure the quality of drugs handled. In order to reach 100 square meter, the storefront area must pass GSP (Good Manufacturing Practices) certification.
What conditions should an individual have to open a pharmacy? 1, a pharmaceutical technician qualified according to law.
2. Having business premises, equipment, storage facilities and sanitary environment suitable for the drugs handled.
3. There are quality management institutions and management personnel suitable for the drugs handled.
4, there are rules and regulations to ensure the quality of drugs.
5. To apply for opening a pharmacy, an application shall be made to the local municipal drug regulatory agency or the county-level drug regulatory agency directly established by the drug regulatory department of the people's government of a province, autonomous region or municipality directly under the Central Government. After applying for a Drug Business License, the applicant shall go through the registration formalities with the administrative department for industry and commerce.
What are the procedures for an individual to open a pharmacy? What are the procedures and bidding procedures for individuals to open pharmacies?
1. Approve the newly established or off-site pharmaceutical retail enterprises to issue the Pharmaceutical Business License.
2. All units and individuals who meet the requirements of relevant laws and regulations on industrial and commercial administration and drug supervision and management may apply for the establishment or relocation of a new drug retail enterprise within the Dalian municipal area in accordance with the relevant provisions of the Drug Administration Law of People's Republic of China (PRC), the Quality Management Standard for Pharmaceutical Trading (GSP) and the Interim Provisions on the Establishment of Retail Pharmacy of the State Pharmaceutical Products Supervision and Administration Bureau. 3. Where a sole proprietorship or joint-stock cooperation applies for the establishment of a pharmaceutical retail enterprise, the person in charge of the enterprise shall work full-time in the newly established pharmaceutical retail enterprise; There is no legal record of defective products; And passed the unified examination organized by the Municipal Drug Administration.
4. The person in charge of a pharmaceutical retail enterprise shall have relevant professional titles or high school education or above (township junior high school education or above) and more than 3 years working experience in medicine and pharmacy.
5, pharmacy must be equipped with pharmaceutical technicians; Pharmaceutical retail enterprises dealing in prescription drugs and Class A OTC drugs in four districts, pilot areas and urban areas of Dalian shall be equipped with licensed pharmacists or other pharmaceutical technicians with professional qualifications to deal in Class B OTC drugs, and equipped with business personnel who have passed the examination organized by the Municipal Drug Administration. The above professional and technical personnel must be on-the-job employees of this enterprise, and may not hold concurrent positions.
6. Adhere to the principles of rational distribution, convenient drug purchase, openness, justice and fairness. Standard for the use area of business premises: the area of four districts, pilot areas, districts, cities and counties in Dalian shall not be less than 80 square meters; The area of township warehouses shall not be less than square meters. Standard: It is suitable for the business scale and shall not be less than 20 square meters.
1. Go to the industrial and commercial office to pre-apply for the store name, and then submit the pre-application to the market office of the local food and drug administration. The application materials are available on the websites of provincial and municipal bureaus.
2. After the acceptance of materials, you can prepare the decoration according to the materials of the provincial bureau.
3. There are rigid requirements for business areas and personnel qualifications. You can consult the registration office of the municipal bureau first.
Prerequisites:
1. It is more troublesome to invest in opening a pharmacy, except for business license, tax registration certificate, hygiene license and health certificate.
2. You also need a drug business license and a medical device business license.
3. Moreover, there are many software and hardware requirements for drug retail stores, mainly hardware and housing equipment, and the software is mainly licensed as a professional pharmacist.
The following is the information on the Internet for reference-the newly revised Drug Administration Law of People's Republic of China (PRC) stipulates that any individual or organization must meet the following conditions to start drug business:
First, it has qualified pharmaceutical technicians according to law; Second, it has business premises, equipment, storage facilities and sanitary environment suitable for the drugs it deals in; Third, it has quality management institutions and management personnel suitable for the drugs it deals in; Fourth, there are rules and regulations to ensure the quality of drugs handled.
To apply for the establishment of a pharmacy, an application shall be made to the local municipal drug supervision and administration institution or the county-level drug supervision and administration institution directly established by the drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government. After applying for a Drug Business License, the applicant shall go through the registration formalities with the administrative department for industry and commerce.
1. The business place shall not be less than 20 square meters (pharmacies in rural areas are not required to have warehouses). There should be at least one resident pharmacist and one salesperson (a person who has graduated from high school or above or is related to pharmacy or has passed the examination by the drug supervision department and obtained an employment certificate).
2. To apply for a Drug Business License, you should also apply for a business license, a tax registration certificate, a hygiene license and a health certificate.
If you open a pharmacy in the city, you must meet these conditions:
1. The business site shall not be less than 40 square meters and the warehouse shall not be less than 20 square meters. There should be at least 1 resident pharmacists and 1 salespersons (persons who have graduated from high school or above or majored in pharmacy, or who have passed the examination by the drug supervision department and obtained the employment certificate).
2. To apply for a Drug Business License, you should also apply for a business license, a tax registration certificate, a hygiene license and a health certificate.
Newly opened pharmacies should also implement GSP certification, which means: drug management quality management, and everything is operated according to GSP mode. Yes, the procedure is more demanding than setting up an ordinary company. You have to go to the provincial office for pre-approval of drug licensing before you can register with the local industrial and commercial bureau.
The following is the information on the Internet for reference-the newly revised Drug Administration Law of People's Republic of China (PRC) stipulates that no matter an individual or an organization, the following conditions must be met for starting a drug business: First, pharmaceutical technicians who have passed the qualification examination according to law must be available; Second, it has business premises, equipment, storage facilities and sanitary environment suitable for the drugs it deals in; Third, it has quality management institutions and management personnel suitable for the drugs it deals in; Fourth, there are rules and regulations to ensure the quality of the drugs you handle. To apply for the establishment of a pharmacy, an application shall be made to the local municipal drug regulatory agency or the county-level drug regulatory agency directly established by the drug regulatory department of the people's government of a province, autonomous region or municipality directly under the Central Government. After applying for a Drug Business License, it shall register with the administrative department for industry and commerce. The business site shall not be less than 20 square meters. Rural pharmacies are not required to have warehouses. At least 1 resident pharmacists and 1 shop assistants (those who have graduated from high school or above or majored in pharmacy or passed the examination by the drug supervision department and obtained the employment certificate). 2. Apply for a Drug Business License,
20 16 What are the procedures for opening a new pharmacy in Baoying County? 1. The business place shall not be less than 20 square meters (pharmacies in rural areas are not required to have warehouses). There should be at least one resident pharmacist and one salesperson (a person with a high school education or above or a pharmacy-related or an employment certificate after examination by the drug supervision department).
2. First, handle the Drug Business License and Medical Device Business License, and then handle the Business License, Tax Registration Certificate, Hygiene License and Health Certificate.
If you open a pharmacy in the city, you must meet these conditions:
1. The business site shall not be less than 40 square meters and the warehouse shall not be less than 20 square meters. There should be at least 1 resident pharmacists and 1 shop assistants (persons who have graduated from high school or above or majored in pharmacy, or who have passed the examination by the drug supervision department and obtained the employment certificate).
2. First, handle the Drug Business License and Medical Device Business License, and then handle the Business License, Tax Registration Certificate, Hygiene License and Health Certificate.
Newly opened pharmacies should also implement GSP certification, which means: drug management quality management, and everything is operated according to GSP mode.
Whether you approve or not depends on how much money you send.
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Keywords GSP, hygiene license, drug trading license, business license of enterprise legal person, licensed pharmacist,
If you want to operate health care products, you need a food and drug business license.
According to the provisions of the Drug Administration Law, the establishment of a pharmaceutical trading enterprise must meet the following conditions: (1) having qualified pharmaceutical technicians according to law; (2) Having business premises, equipment, storage facilities and sanitary environment suitable for the drugs handled; (3) It has a quality management organization or personnel suitable for the drugs it deals in; (4) Having rules and regulations to ensure the quality of drugs.
To apply for the establishment of a pharmacy, an application shall be made to the local municipal drug regulatory agency or the county-level drug regulatory agency directly established by the drug regulatory department of the people's government of a province, autonomous region or municipality directly under the Central Government. After applying for the Drug Business License, you should register with the administrative department for industry and commerce.
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Annexes: 1. Licensing Contents "Pharmaceutical Trading License" (Retail) 2. Legal and regulatory basis for setting up the license (1) Drug Administration Law of People's Republic of China (PRC), Regulations for the Implementation of Drug Administration Law of People's Republic of China (PRC) (2) Standards for Quality Management of Pharmaceutical Trading, Detailed Rules for the Implementation of Standards for Quality Management of Pharmaceutical Trading (3) Measures for the Administration of Pharmaceutical Trading Licenses. (2) Pharmaceutical technicians with legal recognition; Among them, the establishment of retail pharmacies in urban areas must be equipped with two pharmaceutical technicians with the title of pharmacist or above, of which 1 is the quality supervisor; Township retail pharmacies must be equipped with 1 pharmaceutical technicians. (3) Having business premises, equipment, storage facilities and a hygienic environment suitable for handling drugs; Among them, the business area of urban retail pharmacies shall not be less than 40 square meters. The business area of retail pharmacies in the town shall not be less than 30 square meters, and the business area of retail pharmacies in the village shall not be less than 20 square meters. (4) Having rules and regulations to ensure the quality of the drugs handled; (5) Having rules and regulations to ensure the quality of the drugs handled; (6) meeting the requirements of GSP. Four. The applicant applying for the preparation of the licensing procedure (1) submits the preparation application materials to the acceptance window-acceptance-review by the US Food and Drug Administration and issue opinions-the window receives the approval results (2) The applicant applying for acceptance has completed the preparation. Submit the acceptance application materials to the acceptance window-acceptance-inspection organized by the municipal US Food and Drug Administration-examination by the municipal US Food and Drug Administration-receiving the approval results from the window V. Preparation of application materials The applicant submits an application to the municipal US Food and Drug Administration and submits the following materials: (in duplicate) 1. Business application report. Explain the basic situation of the applicant, the reasons for starting, the nature of the enterprise, the business address, scope, personnel, facilities, etc. 2. Notice of pre-registration and approval of new enterprise name issued by the administrative department for industry and commerce. 3. Legal representative (person in charge of the enterprise): A. ID card, temporary residence permit or household registration book B. Notice of appointment (state-owned, collective and joint-stock enterprises). 4. Pharmaceutical technicians: A. Identity card, temporary residence permit or household registration book; B. professional qualifications and professional title certificates; C. labor contracts and letters of appointment; D. on-the-job certification materials. 5. Property right certificate and lease agreement or property right certificate for managing the warehouse site. 6, quality management system directory. Note: the documents in the above materials need to be copied, and the original documents should be returned to the applicant after verification. (II) Accepting the application (III) After the applicant completes the preparation, he shall submit an application for acceptance to the US Food and Drug Administration and submit the following materials (in duplicate): 1 Apply for acceptance and certification; 2, "Drug Business License" (retail) application form; 3, enterprise self-inspection report; 4. ID card of the legal representative (person in charge of the enterprise), residence booklet or temporary residence permit, training certificate of drug-related laws and regulations, resume 5, certificate of registered professional title, unemployment certificate, copy of ID card of pharmaceutical professional and technical personnel suitable for business, letter of appointment of pharmaceutical professional and technical personnel, and labor contract; 6. Proof of the use of business premises and warehouses; 7, all kinds of management rules and regulations (especially drug quality management system); 8. Schematic diagram of classified display scheme of drugs in business premises.
What are the procedures for opening a pharmacy in Lanzhou? What are the procedures and bidding procedures for opening a pharmacy in Lanzhou?
I. Contents of examination and approval
Approve the newly established or relocated pharmaceutical retail enterprises and issue the Pharmaceutical Business License.
Second, the application conditions
1. All units and individuals who meet the requirements of relevant laws and regulations on industrial and commercial administration and drug supervision and management can apply for starting a new drug retail enterprise or relocating in Dalian according to the relevant provisions of the Drug Administration Law of People's Republic of China (PRC), the Quality Management Standard for Pharmaceutical Trading (GSP) and the Interim Provisions of the State Administration of Pharmaceutical Products on the Establishment of Retail Pharmacy.
2 individual proprietorship or joint-stock cooperation to apply for the establishment of a pharmaceutical retail enterprise, the person in charge of the enterprise shall hold a full-time position in the newly established pharmaceutical retail enterprise; There is no legal record of defective products; And passed the unified examination organized by the Municipal Drug Administration. The person in charge of a pharmaceutical retail enterprise shall have relevant professional titles or high school education or above (with township junior high school education or above) and more than 3 years of medical and pharmaceutical work experience.
3, pharmacy must be equipped with pharmaceutical technicians; Pharmaceutical retail enterprises dealing in prescription drugs and over-the-counter drugs of Class A in the four districts, pilot areas and urban areas of Dalian shall be equipped with licensed pharmacists or other qualified pharmaceutical technicians according to law. Those who deal in Class B OTC drugs shall be equipped with business personnel who have passed the examination organized by the Municipal Drug Administration. The above professional and technical personnel must be on-the-job employees of this enterprise, and may not hold concurrent positions.
4, adhere to the principle of reasonable layout, convenient drug procurement and openness, justice and fairness. Standard for the use area of business premises: No less than 80 square meters in the four districts, pilot areas, districts, cities, counties and urban areas of Dalian; The area of villages and towns shall not be less than square meters. Standard of warehouse use area: it should be suitable for the business scale and not less than 20 square meters.
Where rural towns and villages are located, there may be 1 to two with a population less than 1 10,000, and each increase in 1 10,000 population may increase by 1, and the number of newly opened stores of GSP-certified pharmaceutical retail chain enterprises may increase by 1; Others can set up 1 drug retail enterprises.
The newly opened stores of GSP-certified pharmaceutical retail chain enterprises should be more than150m away from the stores of other GSP-certified pharmaceutical retail chain enterprises.
There may be 1 to 2 pharmaceutical retail enterprises in large supermarkets (referring to the business premises with an area of more than 5,000 square meters) and large rural markets.
Three. Materials and certificates that should be submitted at the same time when submitting the application (material 1)
1, application for startup or relocation;
2. Feasibility study report;
3. The applicant's ID card, employment certificate, unemployment certificate, retirement certificate and academic certificate; Proof that there is no record of defective products in law (issued by the police station or sub-district office where the household registration is located).
4, pharmacy location map (150 meters) and internal layout map (indicating the business area and warehouse area).
5. Qualification certificates, employment agreements and relevant notarized materials of licensed pharmacists and other pharmaceutical technicians.
6. Notice of pre-approval of enterprise name by the administrative department for industry and commerce.
Iv. application acceptance conditions
(1) Having a management system that meets the requirements of GSP.
(two) prescription drugs and over-the-counter drugs should be managed and placed in tanks (cabinets), and obvious signs and warning (advice) words should be hung.
(3) Having a complete record of drug procurement quality acceptance.
(4) Having normal temperature, cold storage and cold storage equipment meeting the requirements of drug characteristics.
(five) the qualification certificate file of pharmaceutical technicians is hung in a prominent position in the business place.
(6) meeting other requirements stipulated by GSP.
Pharmacists) or other pharmaceutical technicians are on-the-job employees of the enterprise;
Five, the application for acceptance should be submitted at the same time the materials and certificates (material 2)
1, health examination file and health certificate;
2. Professional post training certificate for pharmaceutical practitioners;
3. Texts that meet the requirements of GSP management system;
4, housing property certificate or lease contract;
5 other materials required by the Municipal Drug Administration.
What conditions should an individual have for starting a business? Brain capital, capital, supplier or business partner, good interpersonal relationship, understanding of the market, forecasting ability, development ability and adaptability.