What formalities are required to open a pharmaceutical wholesale and retail enterprise?

According to the "Chinese People's **** and the State Drug Administration Law":

Article 14 The opening of a pharmaceutical wholesale enterprise shall be approved by the drug supervision and management department of the people's government of the province, autonomous region or municipality directly under the central government where the enterprise is located and issued with the "Drug Business License"; the opening of a pharmaceutical retail enterprise shall be approved by the drug supervision and management department of the local county above where the enterprise is located and issued with the "Drug Business License". License". Without the "drug business license", shall not operate drugs.

The Drug Operation License shall indicate the expiration date and scope of business, and the expiration date shall be re-examined and issued.

Pharmaceutical supervision and management department to approve the opening of the drug business, in addition to the conditions set out in Article 15 of this Law, should also follow the principle of rationalization and convenience of the public to purchase drugs.

Article 15 The following conditions must be met in order to open a pharmaceutical enterprise:

(1) a qualified pharmacy technician in accordance with the law;

(2) a place of business, equipment, warehousing facilities, sanitation and hygiene environment appropriate to the operation of the drug;

(3) a quality management organization or personnel appropriate to the operation of the drug;

(4) a quality management organization or personnel;

(5) a quality control organization or personnel;

(6) a quality control organization or personnel appropriate to the operation of the drug. /p>

(d) have to ensure that the quality of the drugs operated by the rules and regulations.

Expanded:

.

According to the "People's Republic of China *** and the State Drug Administration Law":

Article 17 The purchase of drugs by drug business enterprises must establish and implement a system of inspection and acceptance of incoming shipments and inspection of certificates of conformity of the medicines and other markings; failing to meet the prescribed requirements, shall not be purchased.

Article XVIII of the drug business enterprises purchase and sale of drugs, there must be a true and complete purchase and sale records. Purchase and sale records must indicate the generic name of the drug, dosage form, specifications, batch number, expiration date, manufacturer, purchase (sale) unit, purchase (sale) quantity, purchase (sale) price, purchase (sale) date and the State Council drug supervision and management department of the other content.

Article 19 of the drug business enterprise sales of drugs must be accurate, and correctly explain the usage, dosage and precautions; allocation of prescriptions must be verified, the prescription of the drugs listed in the unauthorized change or substitution. There are contraindications or excessive dosage of the prescription, should be refused to deploy; if necessary, the prescribing physician to correct or re-signature, before deployment.

Pharmaceutical companies selling Chinese herbal medicines, must be labeled with the place of origin.

Article 20 The drug business enterprises must formulate and implement the drug storage system, to take the necessary refrigeration, anti-freezing, moisture-proof, insect-proof, rodent-proof and other measures to ensure the quality of drugs.

Drugs into and out of storage must implement the inspection system.

Article 21 of the urban and rural fairs and trade markets can sell Chinese herbal medicines, except as otherwise provided by the State Council.

The urban and rural bazaars and trade markets shall not sell medicines other than Chinese herbal medicines, but holders of the "drug business license" of the drug retailers within the scope of the provisions of the urban and rural bazaars and trade markets can be set up to sell medicines other than Chinese herbal medicines. The specific measures shall be stipulated by the State Council.

Baidu Encyclopedia - Chinese People's **** and State Drug Administration Law