What are the procedures and conditions for opening a pharmacy?

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 drug regulatory agency at the municipal level divided into districts or the drug regulatory agency at the county level directly established by the drug regulatory department of the people's government of a province, autonomous region or municipality directly under the Central Government. The pharmaceutical supervisory and administrative institution that accepts the application shall, within 30 working days from the date of receiving the application, make a review in accordance with the provisions of the pharmaceutical supervisory and administrative department of the State Council, combined with the number, region, traffic conditions and actual needs of the local resident population, and make a decision on whether to approve the preparation.

After the establishment of the proposed enterprise is completed, the applicant shall apply to the original examination and approval authority for acceptance. The original examination and approval authority shall, within 30 working days from the date of receiving the application, organize the acceptance in accordance with the relevant provisions of the Drug Administration Law; Those who meet the requirements shall be issued with a Pharmaceutical Business License. The applicant shall register with the administrative department for industry and commerce according to law with the Pharmaceutical Business License.

The process of applying for starting a pharmaceutical wholesale enterprise is basically consistent with the above procedures.

In addition, the implementation regulations also stipulate that the validity period of the Drug Business License is five years. If it is necessary to continue to deal in drugs at the expiration of the validity period, the licensed enterprise shall apply for renewal of the Drug Business License six months before the expiration of the validity period of the license in accordance with the provisions of the drug supervision and administration department of the State Council. Where a pharmaceutical trading enterprise stops trading drugs or suspends business, the original issuing authority shall cancel the Pharmaceutical Trading License.

The drug administration of the autonomous region shall, within 30 working days from the date of accepting the application, review the application materials according to the Standards for the Establishment of Drug Wholesale Enterprises, make a decision on whether to approve the preparation, and notify the applicant in writing. After obtaining the approval document of the preparation and completing the preparation, the applicant shall submit an application for acceptance to the drug administration of the autonomous region and submit the following materials:

1, drug business license application form;

2, the approval document issued by the administrative department for Industry and commerce;

3, the organization of the proposed enterprise;

4, business premises, warehouse layout and housing property rights or use rights certificate;

5. Qualification certificates and letters of appointment of pharmaceutical technicians who have obtained qualifications according to law;

6, the proposed enterprise quality management documents and storage facilities, equipment directory.

After receiving the application for enterprise acceptance, the drug administration of the autonomous region shall, within 30 working days, organize on-site acceptance according to the Implementation Standards for Acceptance of Drug Wholesale Enterprises Established by the State Food and Drug Administration of the United States (for Trial Implementation), and make a conclusion of conformity or non-conformity. Do not meet the standards, issued a "notice of acceptance and rectification", the enterprise should complete the rectification within 30 days, put forward an application for review, and the drug administration of the autonomous region will organize another acceptance.

If it meets the standards after on-site acceptance, the drug administration of the autonomous region will publicize it to the public through the website of the drug administration of the autonomous region 10 day. After the expiration of the publicity period, if there is no objection, the drug administration of the autonomous region will issue the Drug Business License and make an announcement on the website of the drug administration of the autonomous region; If there is any objection, it shall be investigated and verified before handling. If the conditions are not met, the drug administration of the autonomous region shall, within 5 working days, make a notice of not issuing the certificate of establishment of a pharmaceutical trading enterprise and notify the applicant.