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What procedures do Lanzhou individuals need to open a pharmacy?
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 Drugstores.
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 the rural township government is located, there may be 1 to 2 households with a population less than 1, and each increase in 1 population can increase 1, and the number of newly opened stores of GSP-certified pharmaceutical retail chain enterprises can increase1; 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.
(2) Prescription drugs and over-the-counter drugs should be placed in different areas (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, cool and cold storage equipment that meets the requirements of drug characteristics.
(five) the qualification certificate 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. The text of the management system meeting the requirements of GSP;
4, housing property certificate or lease contract;
5 other materials required by the Municipal Drug Administration.
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