What are the contents and requirements of the business scope of medical herbal therapy preparations

The current business scope of medical herbal therapy preparations in China is mainly based on the regulatory qualifications of the products - those with consumer/mechanical brands can only operate herbal formula products labeled with disinfection care and physical auxiliary effects. Only entities with relevant business qualifications for national drug approval can sell medical herbal preparations labeled with medicinal therapeutic effects. Crossing this line is basically considered a violation.

When I was helping a community clinic to increase its business operations, the supervisor of the supervision office pointed out cases to remind me. Many practitioners thought that it didn’t matter as long as the ingredients were herbs. They sold Xiaozihao’s herbal antibacterial cream as a medicinal product that could cure eczema, and then they were complained about operating outside the scope. The registration information of the Xiaozihao product was only allowed to be marked with “inhibiting Staphylococcus aureus and E. coli,” and no mention of treatment-related effects could be made in a single sentence.

The corresponding thresholds for different business scopes are quite different. If you only sell products such as herbal cold compress patches with a mechanical brand name and herbal antibacterial liquid with a eliminating brand name, as long as the industrial and commercial business scope adds "first-class medical device sales and disinfection supplies sales" and can produce a complete purchase traceability ledger, the entry threshold is not high. However, if you want to operate Chinese patent medicine herbal preparations with national drug approval, or approved in-hospital herbal preparations, the requirements are much stricter: not only must you first obtain a drug business license, the business scope must clearly indicate the relevant categories of "Chinese patent medicines, Chinese medicine decoction pieces", you must also have a resident licensed pharmacist, a drug storage warehouse that meets GSP standards, temperature and humidity control equipment, expiry date ledgers, and a traceability system. Everything else must be in place, and nothing less will fail the review.

There is still a controversial boundary that is not completely unified in the industry: Are the herbal topical ointments and internal decoctions prepared by doctors in traditional Chinese medicine clinics and clinics according to prescriptions considered to be medical herbal therapy preparations that need to be included in the scope of business? One school of thought believes that as long as it is issued to individual patients and is not sold to the public, it is part of the diagnosis and treatment behavior and does not require additional business scope; the other school of thought believes that as long as it involves batch preparation, even if it is only transferred to patients in the hospital, it must go through the in-hospital preparation registration process, otherwise it will be regarded as operating outside the scope. I met a friend who opened a traditional Chinese medicine clinic before. Because he made a batch of dehumidifying herbal ointments and sold them to customers in the store, he was reported as being out of scope. It took him half a month to make rectifications before he resumed business.

Speaking of this, some people may ask, does the herbal repair mask commonly sold by medical beauty institutions and health centers count? If the product has a Class II qualification, you must first add Class II medical device sales to your business scope, and then make the corresponding business registration before selling it. If it is an ordinary skin care product with a makeup brand, even if the ingredients are all herbs, as long as you dare to advertise and sell it with a "medical herbal treatment" label, it is still beyond the scope. The beauty salon downstairs in my house has done this before, promoting ordinary herbal facial masks as medical repair products, and was fined NT$30,000 by market supervision. It was a completely unnecessary loss. Previously, a friend who opened a health care center wanted to sell medicinal herbal preparations, but he tried for almost a month and failed to obtain the qualifications. This was because he had neither a resident licensed pharmacist nor a special medicine storage area, nor was he even equipped with the most basic temperature and humidity recorder. In the end, he only obtained the business permission for a category of medical equipment and herbal products with a consumer brand. He usually sells herbal moxibustion patches and herbal antibacterial sprays without any problem, but if he dares to touch medicinal herbal preparations with therapeutic effects, he will still be punished.