The conditions required for operating Class B over-the-counter drugs are as follows:
1. Drug retail enterprises operating Class B over-the-counter drugs;
2. The district's municipal drug regulatory agency or the county-level drug regulatory agency directly established by the drug regulatory department of the people's government of a province, autonomous region, or municipality directly under the Central Government organizes and assesses qualified business personnel.
If there are no drug retail enterprises in urban and rural market trade markets in remote areas with inconvenient access, local drug retail enterprises can be registered in the urban and rural areas after being approved by the drug regulatory agency of the local county and registered with the industrial and commercial administration department. Set up points in the bazaar trade market and sell over-the-counter drugs within the scope of approved drugs.
The application process for a drug business license is as follows:
1. Submit an application to the local provincial food and drug administration;
2. Submit materials, submit materials related to the type of business you are applying for;
3. Supplement and correct materials, the accepting department will handle them according to different situations, and notify the applicant to supplement and correct the materials;
4. Review stage, the review cycle is 30 working days;
5. Qualification issuance, drug business licenses are issued to qualified units. It takes a long time from application to establishment.
Legal basis: Article 15 of the "Regulations on the Implementation of the Drug Administration Law of the People's Republic of China"
The state implements a classified management system for prescription drugs and non-prescription drugs. The state classifies over-the-counter drugs into Category A over-the-counter drugs and Category B over-the-counter drugs based on their safety.
Pharmaceutical retail enterprises that operate prescription drugs and Class A over-the-counter drugs shall be equipped with licensed pharmacists or other pharmaceutical technicians who have been qualified in accordance with the law. Drug retail enterprises that operate Class B over-the-counter drugs shall have business personnel who have passed the assessment organized by the drug regulatory agency at the districted city level or the county-level drug regulatory agency directly established by the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government.