Drugdu.com expert's response:

The process and requirements for obtaining a Pharmaceutical Trading License are as follows:

I. Application Process

1. Preparation of Application Materials

Pharmaceutical Trading License Application Form: Fill in the enterprise's basic information and application details truthfully.

Copy of the Enterprise's Business License or Name Pre-approval Notice.

Personnel Qualification Certificates:

Identity certificates, academic certificates, and professional title certificates of the legal representative, enterprise leader, and quality leader.

The quality leader must provide a licensed pharmacist registration certificate (for retail enterprises, the quality leader must be a licensed pharmacist).

Qualification certificates for personnel engaged in drug inspection, maintenance, and other positions.

Site Proof Materials:

Property ownership certificates or lease agreements for the business premises and warehouse.

Floor plans of the business premises and warehouse, indicating functional areas such as the pending inspection area, qualified area, and unqualified area, in compliance with the Good Supply Practice for Pharmaceutical Products (GSP).

Facility and Equipment List:

Proof of facilities and equipment that meet business needs, such as refrigeration and freezing equipment, and automatic temperature and humidity monitoring systems (additional equipment verification reports are required for the operation of refrigerated drugs).

Quality Management Documents:

A catalog of quality management systems and operating procedures, as well as key document samples, that comply with GSP.

If the application is handled by an agent, an authorization letter and the agent's identity certificate must be submitted.

2. Submission of Application

Submit a written application and a complete set of materials to the drug regulatory authority at or above the county level where the enterprise is located.

Some regions support online applications through government service platforms.

3. On-site Inspection

After accepting the application, the drug regulatory authority will organize personnel to conduct an on-site inspection of the business premises layout, warehouse conditions, compliance of facilities and equipment, and personnel allocation within the specified time limit.

4. Review and Decision

If the inspection confirms compliance with GSP and relevant regulations, the drug regulatory authority will make a decision to grant the license and issue it.

If the requirements are not met, the authority will provide a written explanation of the reasons. The applicant may resubmit the application after supplementing or correcting the materials or apply for a review.

5. License Collection

The approval authority will issue the license to the applicant within 10 working days from the date of the decision.

II. Application Requirements

1. Subject Qualification

The applicant should be a legally established enterprise legal person or other organization. Individuals are not eligible to apply.

The enterprise must possess independent legal person status and have no record of violations in pharmaceutical trading.

2. Personnel Allocation

Employ professional personnel commensurate with the business scale and scope.

The quality management position should be held by a licensed pharmacist or a person with relevant professional and technical qualifications.

Personnel engaged in inspection, maintenance, and other positions should have undergone professional training and passed assessments.

All personnel should have no prohibitions from working in the pharmaceutical industry.

Specific Requirements:

Wholesale Enterprises: The quality leader must be a licensed pharmacist with at least three years of experience in pharmaceutical trading quality management. The head of the quality management department must be a licensed pharmacist with at least one year of relevant experience.

Retail Enterprises: The legal representative or principal leader and the quality management leader must be licensed pharmacists registered with the enterprise.

3. Site and Facilities

The business premises and warehouse (mandatory for wholesale enterprises) must comply with GSP, possessing adequate space, temperature and humidity control equipment (such as refrigerators and temperature and humidity monitoring systems), and display shelves commensurate with the business scale.

The layout should meet the requirements for drug zoning and classification (e.g., separating prescription drugs from non-prescription drugs and drugs from non-drugs).

Specific Requirements:

Retail Enterprises: The business area should be no less than 60 square meters (higher requirements may apply in some regions). If established in commercial premises such as supermarkets, an independent area is required.

Wholesale Enterprises: Warehouses that meet drug storage requirements, including normal temperature warehouses, cool warehouses, and cold warehouses, must be available.

4. System Requirements

Establish a quality management system document covering procurement, inspection, storage, maintenance, sales, prescription review, and other links to ensure compliance throughout the business process.

Possess a computer management system that complies with drug traceability regulations, enabling real-time recording and traceability queries of drug purchase, sales, and inventory data.

5. Other Requirements

Additional special management requirements must be met for the operation of special drugs (such as narcotic drugs and psychotropic substances).

Retail enterprises should ensure that the business premises and storage areas are relatively independent, while wholesale enterprises should possess larger-scale warehousing and distribution capabilities.