According to the "Regulations for the Implementation of the Drug Administration Law of People's Republic of China (PRC)":
Article 12 To establish a pharmaceutical retail enterprise, an application shall be submitted to the municipal pharmaceutical supervisory and administrative institution where the enterprise is to be established or the county pharmaceutical supervisory and administrative institution directly established by the pharmaceutical supervisory and administrative 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 15 working days from the date of receiving the application, organize the acceptance according to the starting conditions stipulated in Article 15 of the Drug Administration Law; Those who meet the requirements shall be issued with a Pharmaceutical Business License.
According to the Measures for the Administration of Drug Business License:
Article 5 The establishment of pharmaceutical retail enterprises shall conform to the number, region, traffic conditions and actual needs of local permanent residents, the principle of facilitating people to buy medicines, and the following requirements:
1, there are rules and regulations to ensure the quality of drugs handled;
2. Having qualified pharmaceutical technicians according to law;
Pharmaceutical retail enterprises dealing in prescription drugs and Class A OTC drugs must be equipped with licensed pharmacists or other qualified pharmaceutical technicians according to law. The person in charge of quality should have more than one year (including one year) experience in quality management of drug business.
Pharmaceutical retail enterprises dealing in Class B over-the-counter drugs and those established in rural areas below the township level shall be equipped with business personnel in accordance with Article 15 of the Regulations for the Implementation of the Drug Administration Law, and licensed pharmacists if conditions permit. During the business hours of the enterprise, the above-mentioned personnel shall be on duty.
3. The enterprise, its legal representative, the person in charge of the enterprise and the person in charge of quality have no circumstances as stipulated in Articles 75 and 82 of the Drug Administration Law;
4. Having business premises, equipment, storage facilities and sanitary environment suitable for the drugs handled. The establishment of retail pharmacies in supermarkets and other commercial enterprises must have independent areas;
5, have the ability to meet the needs of local consumers, and can guarantee the 24-hour supply. The quantity of national essential drugs that pharmaceutical retail enterprises should possess shall be determined by the food and drug supervision and administration departments of all provinces, autonomous regions and municipalities directly under the Central Government in light of local specific conditions.
If the state has other provisions on dealing in narcotic drugs, psychotropic drugs, toxic drugs for medical use and biological products for prevention, those provisions shall prevail.
Extended data:
According to the Drug Administration Law of People's Republic of China (PRC):
Article 51
To engage in pharmaceutical wholesale activities, it shall be approved by the pharmaceutical supervisory and administrative department of the local people's government of the province, autonomous region or municipality directly under the Central Government, and obtain the Pharmaceutical Business License. To engage in pharmaceutical retail activities, it shall be approved by the pharmaceutical supervisory and administrative department of the local people's government at or above the county level and obtain the Pharmaceutical Business License. Without a Drug Business License, no drug business is allowed.
The Drug Business License shall indicate the validity period and business scope, and shall be re-examined and issued upon expiration. The pharmaceutical supervisory and administrative department shall, in implementing the drug business license, not only meet the conditions stipulated in Article 52 of this Law, but also follow the principle of facilitating the people to buy drugs.
Article 52
Engaged in drug business activities shall meet the following conditions:
1, pharmacists or other pharmaceutical technicians who are qualified according to law;
2. Having business premises, equipment, storage facilities and sanitary environment suitable for the drugs handled;
3. Having a quality management organization or personnel suitable for the drugs handled;
4, there are rules and regulations to ensure the quality of drugs, and in line with the requirements of the drug management quality management standards formulated by the drug supervision and administration department of the State Council in accordance with this law.
Article 53
Engaged in drug business activities, should abide by the quality management norms of drug business, establish and improve the quality management system of drug business, and ensure that the whole process of drug business continues to meet the statutory requirements.
The state encourages and guides the retail chain operation of drugs. The headquarters of an enterprise engaged in drug retail chain business activities shall establish a unified quality management system and perform management responsibilities for the business activities of its retail enterprises. The legal representative and principal responsible person of a pharmaceutical trading enterprise shall be fully responsible for the pharmaceutical trading activities of the enterprise.
Article 54
The state implements a classified management system for prescription drugs and over-the-counter drugs. The specific measures shall be formulated by the drug supervision and administration department of the State Council in conjunction with the health authorities of the State Council.
Article 55
Drug marketing license holders, pharmaceutical production enterprises, pharmaceutical trading enterprises and medical institutions shall purchase drugs from drug marketing license holders or enterprises with pharmaceutical production and trading qualifications; Except for the purchase of Chinese herbal medicines that are not subject to examination and approval management.
China Government Network-Regulations for the Implementation of People's Republic of China (PRC) Drug Administration Law