Non-prescription traditional medicines must ensure safety for users, ensuring timely access to traditional medicines for people...
This Circular details and guides the implementation of a number of articles of the Law on Pharmacy dated April 6, 2016 and the Law amending and supplementing a number of articles of the Law on Pharmacy dated November 21, 2024 (hereinafter referred to as the Law on Pharmacy).
Principles and criteria for classifying non-prescription traditional medicines
The Circular stipulates the principles of classifying non-prescription traditional medicines to ensure safety for users; ensure timely access to traditional medicines for people; be consistent with the actual use and supply of traditional medicines in Vietnam; and be in harmony with the principles and regulations of classifying non-prescription medicines of countries in the region and around the world .
Traditional medicines classified as non-prescription drugs must meet the following criteria:
a- The formula does not contain medicinal herbs or contains medicinal herbs on the List of toxic medicinal herbs issued by the Ministry of Health but has non-toxic results in semi-chronic toxicity testing;
b- Does not have one of the following indications:
Traditional medicine is a medicine composed of one or more medicinal herbs combined according to the theory of traditional medicine or according to folk experience and processed and prepared according to traditional medicine methods, with traditional or modern dosage forms.
- Support treatment or treatment of cancer, tumors; treatment of cardiovascular disease, blood pressure; treatment of liver, gallbladder or pancreatic diseases (except for liver tonic indications); treatment of Parkinson's; treatment of viruses; treatment of fungi (except for topical drugs); treatment of tuberculosis; treatment of malaria; treatment of gout; treatment of asthma;
- Treatment of endocrine diseases; treatment of blood diseases or disorders; treatment of immune diseases or disorders; treatment of kidney and genitourinary diseases (except for indications: kidney tonic, yang tonic); treatment of infectious diseases (except for indications for topical use to treat skin infections);
- Treatment of chronic insomnia; treatment of psychological and mental illnesses; treatment of addiction, support for treatment of addiction (including support for treatment of withdrawal); termination of pregnancy; treatment of dangerous and emerging epidemics according to regulations of the Minister of Health .
Criteria for determining cases of traditional medicine exempted from clinical trials
According to the Circular, traditional medicines recognized by the Ministry of Health as exempt from clinical trials must meet all of the following criteria:
a- The prescription has full information on ingredients, content, effects, indications, dosage, and usage;
b- The medicine does not contain medicinal herbs recommended by the World Health Organization as unsafe and ineffective for users;
c- The prescription has one of the following documents:
- Books by Hai Thuong Lan Ong and Tue Tinh published by reputable domestic and foreign publishers as stipulated in the Decision approving the list of scientific journals that are scored by the State Council of Professors for the fields of pharmacy and medicine;
- The prescription was issued in Decision No. 5013/QD-BYT dated December 1, 2020 of the Minister of Health on promulgating professional documents guiding the diagnosis and treatment of diseases according to traditional medicine, combining traditional medicine with modern medicine.
Traditional medicine has the same ingredients, content, dosage form, indications, and dosage as medicine that was granted a Circulation Registration Certificate before January 1, 2017.
Minh Hien
Source: https://baochinhphu.vn/quy-dinh-ve-dang-ky-luu-hanh-thuoc-co-truyen-duoc-lieu-102250703142615668.htm
Comment (0)