What does the business scope of medical herbal therapy preparations include?

Judging from the current domestic regulatory rules and practical implementation, the core business scope of compliant medical herbal therapy preparations covers three types of products with compliance approvals, namely, herbal medical dressings and nursing preparations that have obtained device name registration/registration certificates, and Herbal preparations of Chinese patent medicines that have received drug approval, as well as herbal disinfectant preparations that have been registered under a formal trade mark, herbal skin care products under ordinary makeup brands, and herbal food supplement products under food brands, even if they feature herbal ingredients, are not covered by this business scope.

I used to help an acquaintance who runs a community physical therapy center to change the business scope. At that time, he wanted to add a Zhuang brand herbal repair cream he purchased to this category for sale, but the window staff directly called him back. Later, he secretly put it on the shelves without taking it seriously. Within two months, he was randomly inspected by the city supervisor and fined more than 2,000 yuan. To put it bluntly, he had stepped on the red line of operating beyond the scope of business.

Speaking of this, some people may ask, can the herbal ointments prepared by the hospital be included in this business scope and sold? This is actually a point of great controversy in the industry now. At present, regulatory standards vary from place to place. In some areas of Jiangsu and Zhejiang, business entities with medical distribution qualifications are allowed to sell herbal preparations that have obtained formal hospital preparation approvals. However, most areas in the central and western regions still implement strict in-hospital preparation circulation rules, requiring that such products can only be used within the medical institutions where they are developed, and ordinary commercial entities are not allowed to be sold outside within the scope of their business.

In fact, the boundaries of this business scope are a bit like the business license of community pharmacies. You can sell over-the-counter drugs after obtaining a general drug business qualification. If you want to sell prescription drugs, you must add corresponding qualifications. You can't just stuff them into this category casually as long as the ingredients are herbal and they are advertised as having medical effects. If you only plan to sell products such as herbal medical cold compresses and nursing sprays with Category II device brands, just apply for a Category II medical device business registration. If you want to sell herbal oral preparations and ointments with drug-approved brands, you have to apply for an additional drug business license. Different categories of products require different qualifications. Don’t find it troublesome. If you step on the red line, you will be fined a lot. If you really plan to add this business scope, it's best to call the local city supervisor's approval window in advance to ask about the specific local requirements. After all, the standards in different places do vary, so you can save yourself several trips.