What is the business scope of medical herbal therapy preparations

The core of the current business scope of domestically compliant medical herbal therapy preparations is to strictly match the regulatory qualifications of the products. The boundaries of the categories that can be operated corresponding to different approval documents are very clear, and operations beyond the scope of qualifications must not be allowed.

I ran into this trap last year when I helped a friend who opened a community physical therapy center in Suzhou to obtain business qualifications. At that time, he only applied for a business license for medical mugwort hot compresses and herbal moxibustion strips with a mechanical brand name. Customers in the store always asked if they had any exorcisms. As for mosquitoes, I just put the herbal mosquito repellent spray sent by the supply chain to the front desk for sale without adding any business scope. As a result, it was randomly inspected by the city supervisor and fined 18,000 yuan just half a month after it was put on the shelves. It was a small business, and all of a sudden I wasted two months on it.

The most controversial issue in the industry now is the category of homemade herbal preparations produced by traditional Chinese medicine institutions. Many friends who open traditional Chinese medicine clinics feel that the herbal ointments and topical medicinal wines prepared by their own doctors based on experience are not counted as bulk sales to external parties as long as they are sold to patients who come to the clinic for treatment. For sale, there is no need to apply for approval of preparations from medical institutions. This view is really not a minority. Practitioners who support loosening restrictions believe that traditional Chinese medicine herbal preparations are inherently flexible and can be adjusted according to individual needs. Too strict restrictions will restrict many effective ancient prescriptions. However, the regulatory end and other parties Practitioners are more supportive of strict control. After all, mass-produced preparations have not been tested for toxicology and effectiveness. In the event of allergies or misuse, consumers will not even have a basis to defend their rights. After almost two years of quarrel, the current rules are still followed: if the patient is treated on a per-person basis, It does not require preparation approval and does not exceed the scope. However, as long as the homemade herbal preparation is filled in batches and put on the shelves for public sale, it must obtain the preparation number of the medical institution approved by the provincial Food and Drug Administration. Otherwise, it is an out-of-scope operation, and in serious cases, it will be held accountable for selling counterfeit drugs.

If you are an online e-commerce channel, the scope of your business will be even stricter. A while ago, a fan of herbal derivatives came to me to complain, saying that his Xiaozihao herbal antibacterial gel was obviously produced by a regular manufacturer, and he wanted to be listed on the platform for medical use. Draining traffic in the herbal category will not pass the trial. In fact, the business scope of Xiaozihao can only be classified into the disinfectant category. Even if the raw materials are all herbal, it will not be able to attract traffic from the medical category. If it is forced to do so, it will be deducted points and fines for operating outside the scope.

If you are really not sure whether the product you own can be added to your business scope, don’t just search for answers online. Take the product’s registration approval document and go directly to the relevant window of the municipal supervisory authority in your jurisdiction to ask. Supervision standards in different regions may occasionally be slightly different. Asking in person is better than anything else, so as to avoid pitfalls later.