What does the business scope of medical herbal therapy preparations include

The current business scope of domestically compliant medical herbal therapy preparations is completely bound to the approval qualifications obtained by the business entity from the drug regulatory and health departments. The core covers the four major categories of related herbal preparations that have been registered: medicinal, medical consumables, disinfection, and physiotherapy supporting categories. All business categories cannot exceed the scope of qualification approval.

I encountered related pitfalls two years ago when I was helping a community Chinese medicine clinic near my home to upgrade its business qualifications. At that time, the clinic planned to sell a batch of homemade mugwort hot compress packs. At first, we all thought they were ordinary health and daily necessities, but when we submitted the materials, we were reminded by the window staff that, As long as the product packaging or promotion is marked with statements related to medical efficacy such as "medical use" and "assisted in relieving neck and shoulder strain," it must be registered as a class of medical consumables and added to the business scope before it can be sold. Otherwise, it is an out-of-scope operation, and if found, it will be rectified and fined.

At this point, we have to mention the boundary issue that has been controversial in the industry: Are herbal preparations of the same origin as medicine and food considered to be medical? In fact, this boundary all depends on the efficacy claims of the product. For example, if the familiar Qiuli ointment is sold as an ordinary food, it is only labeled as "moistening the throat and nourishing the body," and it is within the scope of food business. However, if it is labeled with medical-related statements such as "relieving pharyngitis symptoms" and "auxiliary treatment of respiratory discomfort", then it belongs to medical herbal therapy. For the category of preparations, you must have a "Pharmaceutical Business License" and add the corresponding category of Chinese patent medicines to the business scope before they can be sold. A friend I know who runs a health center fell into this problem two years ago. The details page of the Qiuli ointment he made said "relieves chronic pharyngitis". He was complained about operating outside the scope and was fined nearly 20,000 yuan. The gain outweighed the gain.

Of course, it does not mean that you can sell anything if you have basic medical herbal preparation business qualifications. Herbal extract preparations for intravenous injection and prescription Chinese patent medicines are all categories that require additional special business qualifications. Ordinary traditional Chinese medicine clinics and physical therapy shops cannot touch them even if they have basic medical consumable business qualifications. This is an absolute red line.

In fact, to put it bluntly, this business scope is logically similar to the permitted driving types of a driver’s license. A person C can only drive a small family car. If he wants to drive a large truck, he must drive a separate car. What level of qualifications you apply for can correspond to what type of products you operate. Don’t think that the raw materials can be sold casually just because they are common herbs. If you are doing import and export business, you need to pay extra attention. Different countries have different classification standards for medical herbal preparations. For example, the European Union will classify most medical herbal preparations into the traditional herbal medicine registration category. The business scope must also include the import and export trade registration of the corresponding category, otherwise it will not even pass customs clearance.