What are the requirements for the business scope of medical herbal therapy preparations?

At present, there is no separate exclusive business scope category for "medical herbal therapy preparations" at the domestic market supervision and drug administration levels. The core requirements for merchants to declare relevant business permissions are completely based on the qualification attributes of the products you want to sell. They must match the qualifications approved by the drug administration and health care departments that they hold 1:1. They can neither exceed the business scope of the qualification declaration nor sell corresponding products beyond the business scope.

I met an old friend who runs a community physical therapy center before. He bought a batch of medical herbal cold compress patches with mechanical brands for sale in the past two years. When he applied for the business license, he only filled in "health care services (non-medical)" and forgot to add the scope of sales of second-class medical devices. After a customer complained to the Municipal Supervision Bureau, not only did it take almost a month to rectify, but he was also fined more than 3,000 yuan. This is a pitfall of mismatch between business scope and qualifications.

If you are making herbal antibacterial preparations, such as commonly used herbal skin disinfectant sprays, foot care antibacterial liquids, etc., you must add "disinfectant sales (excluding hazardous chemicals)" to your business scope. If you produce it yourself, you will need to obtain an additional hygiene license for the disinfection product manufacturer. Here is a point that has been debated in the industry for a long time. Many merchants think that Xiaozihao’s herbal preparations also have some nursing effects, so they want to rely on promoting medical effects. Even if your business scope is complete, such publicity that exceeds the scope is considered a violation. Last year, I saw a colleague being fined 100,000 for promoting Xiaozihao’s herbal antibacterial cream as being able to cure eczema.

There is another category that many people ask about, which is herbal preparations developed by traditional Chinese medicine hospitals or clinics, such as homemade ointments and external liniments. These belong to the category of in-hospital preparations. According to regulations, they can only be used by patients within the medical institution. They cannot be sold to outsiders at all, and naturally there is no way to declare them. According to the scope of external business, if you want to put this kind of self-developed preparations on the market, you must go through a complete drug declaration process and obtain the national drug approval. Otherwise, no matter how easy your prescription is, you will be treated as a fake drug if you sell it privately. You really need to pay special attention to this. Many friends who open traditional Chinese medicine clinics have encountered this problem.

There are now many calls in the industry about whether it is possible to delineate an exclusive business scope for compliant medical herbal therapy preparations, which will facilitate supervision and practitioners' declaration. However, it is still in the discussion stage, and the regulatory standards vary from place to place. In some places, these types of products will be included in the supporting services related to traditional Chinese medicine. Within the business scope, some are still strictly classified according to product attributes into categories corresponding to equipment, disinfection products, and drugs. If you plan to declare the relevant scope, it is best to ask the local market supervision bureau and drug supervision department in advance, and bring all the qualifications of the products you want to operate to the staff to avoid filling in the wrong parts and going back and forth.

If you are just an ordinary health care center and have not obtained any qualifications related to drug supervision, then the most you can add to your business scope is "cosmetics retail" and "daily necessities sales". You can only sell herbal skin care products with cosmetic brands, and you must not touch any herbal preparations that claim to have medical effects. Otherwise, even if the relevant scope is filled in in your business license, it is useless without corresponding qualifications, and it is still considered an operation outside the scope.