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

There is no unified fixed list for this scope, which all follows the approval qualifications of the regulatory authorities. The core business covers the research and development, production, packaging, sales through various channels, and clinical applications of medical institutions of herbal-related medical preparations that have been approved by the Food and Drug Administration and other departments and correspond to different risk levels. Operations beyond the approved categories are basically accurate after checking.

In fact, this thing is like opening a restaurant. You are qualified to sell snacks, but you cannot sell raw seafood that requires special qualifications. The business scope is completely tied to your qualifications, and there is no loophole to exploit. I have been working in this industry for almost four years, and I have seen too many people get into trouble. Let me tell you the most practical limits first - the type of qualification you have obtained corresponds to the scope of your business. For example, if you are approved for the production of traditional Chinese medicine pieces, then your business scope can include the processing, production, and sales of medical herbal pieces, and even supporting decoction services. However, if you only obtain approval for herbal medical cold compress patches with a type of device name, then you can only add the production and sales of category I medical dressings to your business scope, and you must not touch oral and injectable herbal preparations that require a drug brand name or a category II device qualification.

Last year, there was a colleague in our industrial park who made herbal products. His original business scope was only the production and sales of Xiaozihao herbal antibacterial sprays. Seeing that the joint patches were selling well, he added extracts such as mugwort and turmeric to them, and claimed that they were "medical-grade pain relief patches" and sold them as Class II devices. Within two months, he was reported and fined 320,000 yuan. The relevant business scope was directly revoked, and he was not allowed to apply for similar qualifications again within half a year.

There is still a controversial point in the industry that has been quarreling for several years, which is whether products made from herbal raw materials with the same origin as chrysanthemum, honeysuckle, and mugwort need to be approved for medical use? Many practitioners believe that the raw materials themselves are ordinary food grade. As long as no prescription drug ingredients are added, there is no need to go through strict medical qualification approval. However, the regulatory approach has always been clear: as long as your product promotion contains "medical", "healing" and "auxiliary" For expressions such as "aiding treatment", no matter what raw materials are used, you must apply for medical qualifications, and the corresponding category can be added to the business scope. Otherwise, even if you use ordinary chrysanthemums, if you dare to say that your product is a "medical throat preparation", it is considered to be operating outside the scope.

If you open a herbal therapy center in the community and add "retail sales of medical herbal therapy preparations" to your business scope, then you can usually sell herbal moxibustion patches and herbal wound care gels with legal brands to customers. If you don't add this category, you can only sell herbal health tea with food brands at most. If you dare to touch medical products, the Municipal Supervision Bureau will come to your door and punish you directly.

If it involves import and export business, you have to add "import and export trade of medical herbal preparations" to your business scope, and you have to go through customs commodity inspection and approval. I used to know a friend who is a cross-border e-commerce business. Originally, he was only approved for the import and export of ordinary cosmetics. He secretly cleared a batch of herbal medical throat lozenges through the cosmetics channel. The entire batch was directly detained, and he also paid a fine of hundreds of thousands.