Article 11 To establish a pharmaceutical wholesale enterprise, the applicant shall apply to the pharmaceutical supervisory and administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government where the proposed enterprise is located. The pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall, within 3 working days from the date of receiving the application, make a decision on whether or not to approve the establishment according to the establishment standards stipulated by the pharmaceutical supervisory and administrative department of the State Council. After completing the preparation of the proposed enterprise, the applicant shall apply to the original examination and approval department for acceptance. The original examination and approval department shall, within 3 working days from the date of receiving the application, organize the acceptance according to the opening conditions stipulated in Article 15 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.
Article 12 To start a pharmaceutical retail enterprise, the applicant shall apply to the municipal pharmaceutical supervisory and administrative institution located in the district where the proposed enterprise is located 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 3 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 agree to the preparation. After completing the preparation of the proposed enterprise, 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. The applicant shall register with the administrative department for industry and commerce according to law with the Pharmaceutical Business License.
article 13 the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the central government are responsible for organizing the certification of pharmaceutical trading enterprises. A pharmaceutical trading enterprise shall, in accordance with the implementation measures and steps stipulated by the pharmaceutical supervisory and administrative department of the State Council, pass the certification of the Quality Management Standard for Pharmaceutical Trading organized by the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government, and obtain the certification certificate. The format of the certificate of "Good Quality Management Practice for Pharmaceutical Trading" shall be uniformly stipulated by the pharmaceutical supervisory and administrative department of the State Council.
Newly-established pharmaceutical wholesale enterprises and pharmaceutical retail enterprises shall, within 3 days from the date of obtaining the Pharmaceutical Trading License, apply to the pharmaceutical supervisory and administrative department or the pharmaceutical supervisory and administrative institution that issued the Pharmaceutical Trading License for the "Quality Management Standards for Pharmaceutical Trading" certification. The pharmaceutical supervisory and administrative institution that accepts the application for certification of pharmaceutical retail enterprises shall, within 7 working days from the date of receiving the application, transfer the application to the pharmaceutical supervisory and administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government responsible for organizing the certification of pharmaceutical trading enterprises. The pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall, within 3 months from the date of receiving the application for certification, organize the certification of whether the pharmaceutical wholesale enterprises or pharmaceutical retail enterprises applying for certification meet the "Quality Management Standards for Pharmaceutical Trading" in accordance with the provisions of the pharmaceutical supervisory and administrative departments of the State Council; If the certification is qualified, a certification certificate will be issued.
article 14 the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the central government shall set up a database of certified inspectors of the "quality management standards for pharmaceutical trading". "Good Quality Management Practice for Pharmaceutical Trading" certified inspectors must meet the requirements stipulated by the drug supervision and administration department of the State Council. To carry out the "Good Manufacturing Practices" certification, we must randomly select certification inspectors from the "Good Manufacturing Practices" certification inspector library to form a certification inspection team for certification inspection in accordance with the provisions of the drug supervision and administration department of the State Council.
article 15 the state implements a classified management system for prescription drugs and over-the-counter drugs. According to the safety of OTC drugs, the state divides OTC drugs into Class A OTC drugs and Class B OTC drugs.
pharmaceutical retail enterprises dealing in prescription drugs and over-the-counter drugs of Class A shall be equipped with licensed pharmacists or other qualified pharmaceutical technicians according to law. A drug retail enterprise that deals in Class B OTC drugs shall be equipped with qualified business personnel who are organized and examined by the municipal drug supervision and administration institutions with districts or the drug supervision and administration institutions at the county level directly established by the drug supervision and administration departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government.
Article 16 Where a pharmaceutical trading enterprise changes the licensed items of the Pharmaceutical Trading License, it shall apply to the original issuing authority for the registration of the change of the Pharmaceutical Trading License 3 days before the change of the licensed items; Without approval, the licensing matters shall not be changed. The original issuing authority shall make a decision within 15 working days from the date of receiving the application from the enterprise. The applicant shall go through the registration formalities of change at the administrative department for industry and commerce according to law with the changed Pharmaceutical Business License.
article 17 the validity period of the pharmaceutical trading license is 5 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.
if a pharmaceutical trading enterprise stops trading drugs or closes down, the Pharmaceutical Trading License shall be cancelled by the original issuing authority.
article 18 if there are no drug retail enterprises in the urban and rural fairs in remote areas with inconvenient transportation, the local drug retail enterprises can set up their outlets in the urban and rural fairs and sell over-the-counter drugs within the approved drug range after being approved by the local county (city) drug regulatory agency and registered with the administrative department for industry and commerce.
article 19 pharmaceutical production enterprises, pharmaceutical trading enterprises, medical institutions and the drugs they trade through the internet must comply with the provisions of the pharmaceutical administration law and these regulations. Measures for the administration of Internet drug trading services shall be formulated by the drug supervision and administration department of the State Council in conjunction with relevant departments of the State Council.
Drug Administration Law: Chapter III Administration of Pharmaceutical Trading Enterprises
Article 14 The establishment of a pharmaceutical wholesale enterprise must be approved by the pharmaceutical supervisory and administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government where the enterprise is located, and a Pharmaceutical Trading License shall be issued; To set up a pharmaceutical retail enterprise, it must be approved by the local pharmaceutical supervisory and administrative department at or above the county level where the enterprise is located, and a Pharmaceutical Business License shall be issued, and registration shall be made with the administrative department for industry and commerce on the strength of the Pharmaceutical Business License. No drug business license, no drug business.
the drug business license shall indicate the validity period and business scope, and be re-examined and issued upon expiration.
when approving the establishment of a pharmaceutical trading enterprise, the pharmaceutical supervisory and administrative department shall follow the principles of rational distribution and convenience for people to purchase medicines, in addition to the conditions stipulated in Article 15 of this Law.
Article 15 To establish a pharmaceutical trading enterprise, the following conditions must be met:
(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 the drugs handled.
article 16 pharmaceutical trading enterprises must deal in drugs in accordance with the "standards for quality control of pharmaceutical trading" formulated by the State Council pharmaceutical supervisory and administrative department in accordance with this law. The pharmaceutical supervisory and administrative department shall, in accordance with the provisions, certify whether the pharmaceutical trading enterprises meet the requirements of the Quality Management Standards for Pharmaceutical Trading; Certification certificates will be issued to those who pass the certification.
the specific implementation measures and steps of the "Good Quality Management Practice for Pharmaceutical Trading" are stipulated by the drug supervision and administration department of the State Council.
Article 17 When purchasing drugs, pharmaceutical trading enterprises must establish and implement the system of incoming inspection and acceptance, and verify the drug conformity certificates and other marks; Do not meet the requirements, shall not be purchased.
article 18 pharmaceutical trading enterprises must have true and complete purchase and sale records when purchasing and selling drugs. The purchase and sale records must indicate the generic name, dosage form, specification, batch number, expiration date, manufacturer, unit of purchase (sales), quantity of purchase (sales), purchase and sale price, date of purchase (sales) and other contents stipulated by the drug supervision and administration department of the State Council.
article 19 pharmaceutical trading enterprises must be accurate in selling drugs, and correctly explain the usage, dosage and precautions; The prescription must be checked, and the drugs listed in the prescription shall not be changed or substituted without authorization. Prescriptions with incompatibility or overdose should be refused to be prepared; When necessary, it can be prepared only after being corrected or re-signed by the prescriber.
pharmaceutical trading enterprises must indicate the place of origin when selling Chinese herbal medicines.
article 2 pharmaceutical trading enterprises must formulate and implement a drug storage system, and take necessary measures such as cold storage, anti-freezing, moisture-proof, insect prevention and rat prevention to ensure the quality of drugs.
the inspection system must be implemented for drugs in and out of the warehouse.
article 21 Chinese herbal medicines may be sold in urban and rural fairs, unless otherwise stipulated by the State Council.
drugs other than Chinese herbal medicines may not be sold in urban and rural fairs, but pharmaceutical retail enterprises with Drug Business License may set up outlets in urban and rural fairs to sell drugs other than Chinese herbal medicines within the prescribed scope. The specific measures shall be formulated by the State Council.