What is the business scope of medical herbal therapy preparations

Judging from the current domestic regulatory requirements and implementation, the business scope of compliant medical herbal therapy preparations mainly covers the following categories: herbal preparations approved by the regulatory authorities, Class II/I medical herbal preparations, herbal antibacterial care-related medical products, as well as herbal preparations prepared in-hospital by medical institutions that have been registered. Anything beyond this scope is basically illegal operations.

Last year, I helped a community Chinese medicine clinic I knew well to expand its business scope. The staff at the health window in the government affairs hall specifically tried to push me out of the boundaries. I didn’t take it seriously at the time, but I went back and checked the recent punishment notices before I broke out in a cold sweat: There was a fresh food supermarket owner near my home. Seeing the good sales of autumn and winter throat lozenges, he sneaked in He bought dozens of boxes of herbal lozenges with the medical herbal label for sale at the checkout counter. After being reported, his illegal gains were not only confiscated, but he was also fined 2,000 yuan. This was because his business scope was only food and did not involve medical herbal-related herbal lozenges. He also did not apply for a drug business license, which violated the red line of operating beyond the scope of the business.

However, there are still vague areas that have not been completely smoothed out. The most typical one is whether custom-made herbal ointments and decoctions for traditional Chinese medicine clinics are part of the business scope. Many cities in Jiangsu, Zhejiang and Shanghai that I have come into contact with have already relaxed the rules. As long as there are licensed traditional Chinese medicine doctors in the clinic, temporary prescriptions can be prepared. The products are only customized for users who come to the store for medical treatment. They can be added to the business scope without being distributed in batches. However, many northern provinces have not yet relaxed relevant registration. Many store owners are actually doing it on the sidelines. Once they are investigated, they will be easily punished. The industry has also been calling for the unification of relevant standards.

Many owners of skin management stores have also asked me whether the herbal cold compresses and medical moxibustion strips used in the store can be classified into this category. In fact, it depends on the product registration number. If it is a Class II medical device, it is absolutely fine. If it is just an ordinary device Daily necessities or makeup brands do not count. A friend who runs a medical beauty clinic stepped into this pit before and imported a batch of unequipped herbal skin rejuvenating masks for customers to do import projects. He just happened to catch up with the city bureau's unannounced inspection. Not only was the project stopped, but he was also fined nearly 100,000 yuan. The loss was so painful.

In fact, after working in this industry for a long time, you will know that you don’t have to worry about what can be written and what cannot be written. When you apply for an additional project, bring all the qualifications for the products you want to operate. The window staff will directly draw the boundaries for you, which is more reliable than guessing by yourself. After all, the regulatory standards in different places are somewhat different, and it is safest to comply with local requirements.