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

Judging from the current practical standards of domestic supervision, the core business scope of medical herbal therapy preparations covers the three major sectors of production and distribution of preparations that have passed compliance approval, related technical services, and scenario-based derivative applications. However, regulatory details vary greatly from place to place, and it is easy to fall into the trap of operating beyond the scope if you are not careful.

Many friends who are new to the industry tend to confuse this boundary. After all, the current herbal-related product track is too complicated, and supervision is more flexible than ordinary medical devices. Two years ago, I took over a medical herbal ointment manufacturer in Taizhou, Jiangsu Province. The initial business scope they received only covered the production of Class II medical device herbal preparations and supply to offline medical institutions. It did not even include the qualifications for online retail. Later, I wanted to enter the e-commerce platform. It took more than three months of approval and a bunch of product risk assessment materials before adding the category. This was because the regulator was afraid that online promotion of such products would easily exaggerate the efficacy.

There is still a caliber issue that has been debated for a long time in the industry - whether the herbal related products of Xiaozihao and Zhuangzihao can be included in this business scope? The judgments in different places are completely different. Some areas believe that Xiaozihao's herbal antibacterial lotions belong to the category of daily care and cannot be classified as medical herbs. Some areas require that Xiaozihao herbal preparations that are exclusively for medical institutions must be included in this business scope before they can be sold in compliance with regulations. Don’t take it seriously. Last year, there was a herbal antibacterial spray merchant in Zhongshan, Guangdong. In order to take advantage of the traffic of medical herbs, it listed products with ordinary consumer brands for sale under this category. It was directly fined more than 80,000 yuan. It was a violation of the local regulatory red line.

In addition to direct preparation production and sales, if you have technical qualifications, you can also apply for related technical service categories. I know an old pharmacist who has been engaged in herbal processing for more than 20 years. His company was approved for this category. He specializes in R&D and processing technology training of customized external herbal preparations for local public Chinese medicine hospitals. The business has been very stable. However, the threshold for this category is not low. During the approval process, at least three licensed pharmacists must provide qualification certificates.

If you open a herbal therapy center in the community and apply for this category of business, you can only sell approved first- and second-class medical herbal patches and liniments at most. Do not brew herbal ointments in private and sell them to outsiders. Even if the ingredients you use are all compliant medicinal and edible herbs, as long as there is no corresponding preparation batch number, it is still considered to be operating outside the scope. Last year, a local physical therapy center owner was complained about this matter, and was not only fined but also required to make corrections for half a month.

If you really plan to enter this track, don’t just think about what you can write in the scope of business. It is best to go to the local market supervision and health department to ask for the specific access details. After all, the tightness is really different in different regions. Don’t wait until you have stocked up to find out that the qualifications are not right, which will be a waste of time.