Business scope of medical herbal therapy preparations

The first is the retail and wholesale of herbal external preparations with brand names, the second is the operation of herbal antibacterial care products with small brands, and the third is the internal preparation and temporary prescription dispensing services of traditional Chinese medicine medical institutions within the scope of the compliance pilot. At the same time, it is clearly prohibited to sell beyond the scope of the national medicine approved prescription herbal preparations and non-compliant herbal products without qualifications to claim medical efficacy.

I went through this pitfall two years ago when I was helping to issue trotting qualifications for a community health care center. At that time, he thought that the store would focus on herbal physical therapy, and sell herbal cold compresses for bruises and foot bath bags, so he casually added "daily necessities sales" to the business license. As a result, just half a month after opening, he was reported for operating outside the scope and fined 2,000 yuan. You may not believe it, but he sold two boxes of cold compresses at that time and made less than 40 yuan, which was a huge loss. The reason is very simple. The cold compress patch he sells is a Class II device, which belongs to the category of medical herbal preparations. It requires a Class II medical device business registration, which is beyond the scope of ordinary daily necessities sales.

Many people tend to confuse medical herbs with ordinary herbal daily products. In fact, the boundary is clearer than you think. If you are selling Xiaozihao’s herbal antibacterial hand sanitizer and herbal care spray, then as long as the business license contains “disinfectant supplies sales”, it will be no problem. Such products themselves are approved by Xiaozihao and belong to the marginal business of medical herbal preparations. As long as they do not claim to cure diseases, they will basically not step on the line. But if you want to sell the kind of herbal hot compress labeled "for auxiliary treatment of cervical spondylosis", you have to check its qualifications first: if it is a Class I device brand, no additional filing is required, just add "First Class Medical Device Sales" ； If you have a Category II medical device brand name, you must apply for a Category II medical device business registration. For Category III, the requirements are higher and you need a medical device business license. There is no room for bargaining.

The most controversial issue in the industry right now is actually whether products such as herbal ointments and herbal wines prepared on the fly by traditional Chinese medicine clinics are included in the business scope. The view from the regulatory side is very clear: as long as it is a preparation product that is sold externally and charged a fee, regardless of whether it is freshly prepared or not, as long as it claims to have medical effects, it falls within the business scope of medical herbal therapy preparations. If it is a medicinal product, it must hold a medical institution preparation license before it can be sold, otherwise it will be considered outside the scope. The last time I went on a business trip to Yunnan, I saw a local ethnic medical clinic that had been open for more than ten years. It was fined more than 80,000 yuan for selling unqualified herbal wine made by me. The boss complained that it was an ancestral prescription and it was a diagnostic and treatment service. In the end, it still failed to pass the supervision. However, from the perspective of many practitioners of traditional Chinese medicine, temporary prescription preparation is originally a part of traditional Chinese medicine diagnosis and treatment. When customers come to see a doctor, they are given an herbal ointment or a medicinal wine according to their condition. The fees collected are diagnostic and treatment service fees, which should not be counted as preparation operations. There is no need to obtain additional preparation qualifications. This school of thought has also been promoting policy adjustments in the past two years.

In fact, many places are already loosening restrictions, such as the traditional Chinese medicine innovation pilot zones in Zhejiang and Guangdong. As long as you are a formally registered traditional Chinese medicine clinic, the herbal preparations prepared on the spot are only used in the clinic. If you file a case with the local drug regulatory department in advance, it can be included in the diagnosis and treatment service charges. It does not count as an out-of-scope operation, which is equivalent to giving traditional Chinese medicine a compliant operation. There is also the business of cooperating with public hospitals to dispense in-hospital preparations. Now it has been liberalized. As long as you have the corresponding drug business qualifications and signed a dispensing agreement with a public hospital with a preparation license, you can also add the dispensing service of in-hospital herbal preparations to your business scope.

Oh, and there is another pitfall that is easy to step on. Many people will rely on herbal skin care products under the Zhuang brand to be classified as medical herbs. For example, selling a herbal cream and claiming that it can treat eczema and dermatitis is not only false propaganda, but also considered an out-of-scope operation - Zhuang brand products do not fall into the category of medical herbal preparations at all. If you want to sell herbal skin preparations with therapeutic effects, you have to sell ointments with the national drug approval, and then you must apply for a drug business license, which is much higher.

In fact, the boundaries of this business scope are still being adjusted with the innovation of traditional Chinese medicine. If you are really not sure whether the category you want to add can be added, don't just check the laws online, go directly to the local Food and Drug Administration and Market Supervision Bureau to ask. Pilot policies vary from place to place. Maybe your place happens to have loose support policies, which is more reliable than guessing on your own. Don't wait until you open your business and get fined before you think about supplementing your qualifications. By then it will be too late.