Question:
I have a traditional medicine doctor's degree and a practice certificate issued on September 12, 2022 with a practice period of 12 months. I am currently updating my CME knowledge. I want to open a pharmacy selling finished non-prescription oriental medicine products in Dong Nai province, and also provide acupuncture and acupressure services. With my current qualifications and certificates, am I qualified to open a pharmacy? If so, what conditions do I need to meet? Do I need an additional license to perform acupuncture and acupressure at the facility?
Answer
- What is the difference between Oriental medicine and traditional medicine?
When talking about Oriental medicine, many people immediately think of herbal remedies, acupuncture or massage methods. However, in the Vietnamese legal system, this concept does not exist independently but is considered a part of traditional medicine.
According to Clause 8, Article 2 of the 2016 Law on Pharmacy and Clause 2, Article 1 of Circular 44/2018/TT-BYT, Oriental medicine is classified into the group of traditional medicines, including:
- Traditional medicine materials: Raw medicinal materials that have not been processed into finished products.
- Finished traditional medicine: Prepared by traditional or modern methods, can be in the form of pills, liquid, extract, powder, etc.
In addition to using medicine, traditional medicine also includes methods of acupuncture, massage, acupressure, helping to treat diseases and restore function. Therefore, when you want to do business in Oriental medicine or practice acupuncture, you will have to comply with the regulations related to medical examination and treatment using traditional medicine.
- Conditions for opening a non-prescription finished oriental medicine pharmacy
According to Clause 5, Article 31 of Decree 54/2017/ND-CP and Clause 10, Article 5 of Decree 155/2018/ND-CP, to open a finished oriental medicine pharmacy (non-prescription), the following conditions must be met:
- Regarding qualifications: The person in charge of professional responsibility must have one of the appropriate qualifications, including a traditional medicine physician's intermediate degree. You have met this condition.
- Regarding facilities:
- The pharmacy must have a fixed, separate, sturdy, clean, airy location, away from sources of pollution.
- The facility must have a suitable storage area to avoid affecting the quality of the medicine.
- If trading in toxic medicinal herbs, there must be a separate area and clear warning signs.
- Regarding legal procedures:
- Need to apply for a Certificate of eligibility for pharmaceutical business at the Department of Health of Tra Vinh province.
- The dossier includes: application for a license, business registration certificate (if any), valid copy of practice license, list of facilities, list of personnel.
With the above regulations, you have met the professional qualifications to open a traditional medicine pharmacy, but you need to ensure that the facilities meet standards and complete the licensing procedures according to regulations.
- Conditions for performing acupuncture and acupressure at the facility
Acupuncture and acupressure are within the scope of traditional medicine examination and treatment. Therefore, according to Clause 1, Article 48 of the Law on Medical Examination and Treatment 2023, to perform this service, you need to establish a Traditional Medicine Clinic. The conditions according to Articles 40, 46 and 52 of Decree 96/2023/ND-CP include:
- Regarding personnel: The person responsible for technical expertise must have a license to practice traditional medicine, must be a full-time practitioner of the facility and have practiced in that scope for at least 36 months.
Therefore, if you only have 12 months of experience, not enough 36 months to open a clinic yourself, you need to cooperate with a traditional medicine doctor, traditional medicine practitioner or someone with a traditional medicine prescription.
- Regarding facilities:
- Fixed location, ensuring safety, hygiene, fire prevention and fighting.
- There are acupuncture beds, acupressure tools, and acupuncture treatment equipment (anti-shock).
- Regarding legal procedures:
- Need to apply for a license to operate a traditional medicine clinic at the Department of Health of Tra Vinh province.
- The dossier includes: application, copy of practice license, list of personnel, medical equipment, and certificate of facility meeting medical examination and treatment conditions.
Based on the above regulations, you can perform acupuncture and acupressure, but need to apply for a license to operate a traditional medicine clinic. If you do not have enough experience, you must cooperate with a qualified person to open a legal facility.
- Some notes on practice certificates
From January 1, 2024, your current practice certificate is still valid as a practice license, but you need to pay attention to the renewal period. According to Clause 3, Article 143 of Decree 96/2023/ND-CP, from 2030, all practice licenses will be valid for 5 years/time and if not renewed before 2035, your certificate will expire. Therefore, you need to monitor the practice period to be able to register your own business. At the same time, you need to renew your practice certificate according to regulations to ensure long-term operation.
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