Business scope of medical herbal therapy preparations

First, the operation of herbal dressings, herbal liniments, acupoint pressure stimulation patches and other external preparations that have obtained Class I medical device registration qualifications must have the corresponding Class I medical device sales qualifications.； The second is herbal derivative preparations that belong to the category of medicine and food and general cosmetics (cosmetic brands). They can only claim soothing and nursing non-medical effects. No additional special qualifications are required for operation. They only need to match the health care, cosmetics or food sales categories on the business license. ； Third, the operation of Chinese patent medicine herbal therapy preparations and approved in-hospital herbal preparations of medical institutions that have obtained national drug approval requires a "Drug Business License", and in-hospital preparations can only be circulated and sold within the scope of approved medical institutions and cannot be sold to the general market.

In the past two months, I helped Fa Xiaopao, a community physical therapy center, expand its business scope. I stepped through several pitfalls before I understood these boundaries clearly. At that time, he had just bought a batch of homemade herbal analgesic ointment from an old Chinese medicine practitioner in his hometown. He thought it was very effective and wanted to sell it at the front desk. I accompanied him to the city supervisor for questioning, but was directly beaten back by the staff - that batch of ointment had neither a registered trademark nor a medical approval. It was a typical "three noes" homemade product. Let alone selling it, displaying it was considered illegal.

There is actually a lot of controversy over the delineation of this business scope in the industry. Many practitioners in traditional Chinese medicine clinics I have met feel that the current threshold is a bit high. Many small herbal prescriptions that have been passed down for generations are much better than mass-produced products on the market. However, the clinical data required for approval are not available, and they cannot obtain qualifications. They can only be used by regular customers in the clinic, and they cannot be circulated in compliance with regulations. But friends at the regulatory authorities also have their own reasons. Last year, their jurisdiction just investigated a homemade herbal rhinitis spray sold by an Internet celebrity. The merchant claimed that it was "pure herbal and hormone-free", but in fact, it secretly added excessive glucocorticoids and sold tens of thousands of bottles. In the end, dozens of consumers came to the door with drug-induced rhinitis. If the access requirements for business scope are really relaxed, there will only be more merchants taking advantage of the loopholes.

Last week when I went to the Municipal Supervisory Office, I met three ladies who run a health center and asked the staff around. They carried half a bag of products: mugwort foot soaking packs, herbal mosquito repellent, warm patches with mugwort ingredients, and herbal patches that claim to relieve low back pain. They asked each one which one they could sell. The staff flipped through the directory for almost ten minutes and gave them a clear description: the foot soaking bags are of the same origin as medicine and food and can be sold. ； Mosquito repellent liquid is sold under the makeup brand name and can also be sold ； If the heating patch only says "hot compress to keep warm", then there is no problem. If it says "treating uterine cold", it must be classified as a category of equipment and needs to be filed. ； The package of the herbal patch for low back pain is printed as "Assistant treatment of lumbar muscle strain". You must have the qualifications to sell a type of device before you can sell it. Otherwise, you will be fined at least 5,000.

By the way, friends who are e-commerce companies should be more careful. Platform rules are stricter than offline ones. I have a customer who runs a Dou shop. He used to sell herbal cervical vertebra patches with a mechanical brand name. The details page accidentally added the words "radical cure for cervical spondylosis". The platform immediately took it off the shelves and deducted the deposit. It was also complained to the city supervisor. In the end, the customer was compensated three times of the purchase price before the matter was settled. Don’t think that as long as you have all the qualifications, you can make random publicity. The business scope gives you the qualification to sell the corresponding category, but it does not give you permission to brag about its efficacy.

There is another misunderstanding that many people tend to make, that is, they think that the herbal preparations prepared by traditional Chinese medicine clinics can be freely sold for takeout. An old traditional Chinese medicine doctor I worked with before suffered this loss. The burn ointment he prepared himself was very effective. People around him came to buy it, so he asked his friends to put it outside. I was selling it on behalf of a local pharmacy, but I was reported and fined hundreds of thousands, and my medical license was almost revoked. The circulation range of in-hospital preparations is strictly limited to this medical institution. No matter how effective you are, you can't sell it outside without obtaining the national drug approval. This is a red line.

Of course, policies are now being adjusted in a more flexible direction. Last year, the State Food and Drug Administration issued a simplified approval policy for classic famous prescriptions. Many herbal prescriptions that have been passed down for hundreds of years can go through the fast-track approval channel without having to undergo redundant clinical trials. In the future, there may be more compliant herbal therapy preparations that can be included in the general business scope, and no longer need such strict qualification requirements.

If you are not sure whether the product you want to sell is within the scope of your business, don’t search for expired information on the Internet, and don’t listen to your peers who say “everyone else is selling it, it’s okay.” Go directly to the commercial registration window of the local city supervisor with the product packaging and qualification documents to ask. The staff will give the most accurate answer, and you will save yourself the trouble of having to pay fines later.