What does the business scope of medical herbal therapy preparations include

At present, the business scope of medical herbal therapy preparations approved by the domestic industrial and commercial and drug regulatory authorities is mainly tied to the registration/registration qualification of the product. The compliant and operable categories basically cover the three major categories of medical herbal preparations with approved brands, herbal physiotherapy care preparations with mechanical brands, and compliant consumer/cosmetic herbal preparations with efficacy claims. Anything that exceeds the categories corresponding to the self-registered registration qualifications is an out-of-scope operation.

Maybe it’s a bit empty to say this. Let me share with you some actual cases that I have encountered in the past two years while working as an industrial and commercial agency and it will become clear. For example, herbal medicines starting with Z, such as compound lithospermum oil and herbal formula cold granules that are often prescribed in hospitals, must obtain a "Drug Business License" before they can be included in the business scope. Ordinary health centers and daily necessities stores cannot sell them at all; there are also in-hospital herbs prepared by medical institutions themselves. This preparation is only for internal use within the institution and is not allowed to be circulated to the outside at all. Anyone who sells it will be considered out of scope. Last year, the owner of a maternal and child store secretly purchased a batch of homemade herbal eczema ointment from a children's hospital. He did not obtain the drug business qualification and even promoted it to cure eczema. He was fined hundreds of thousands for selling the drug in violation of regulations.

There is also a vague point in this industry that has been debated for a long time, that is, herbal products that have the same origin as food and medicine. If they focus on medical conditioning effects, can they be included in this business scope? Many practitioners in the health and wellness industry believe that medical-grade herbal tea substitutes and herbal dietary supplements should be included as long as they meet the standards of special medical food. However, the current regulatory standards are still relatively strict, as long as they are products with food or special food brands. , even if medical herbal raw materials are used, as long as they promote "treatment" and "medical efficacy", they will be considered outside the scope. At most, they can only be claimed as "auxiliary conditioning", and they must be within the scope of food business, and cannot be counted under the category of medical herbal preparations.

There are also many novices who easily confuse the level of device brands. Herbal cold compress gel and moxibustion liquid for Class I devices can be added to the business scope as long as they apply for a Class I medical device business registration. Herbal hot compress patches and medical herbs for Class II devices can be added to the business scope. This care solution requires an additional Class II medical device business registration. Last month, I met the owner of a physical therapy center. He bought a batch of Class II herbal shoulder and neck patches without knowing it. He was complained and fined 18,000 RMB 18,000 just 3 days after it was put on the shelves. It was really unfair.

If you really want to do this business, don’t just look at the product name with “medical herbal” in it. First, check the registration number on the product package, go to the drug regulatory system to check the corresponding qualification requirements, and then go to the industrial and commercial department to add the corresponding business scope. It’s always wise to be prudent.