[HEALTH LAW ARTICLE]

In medical care, examination and treatment activities, drugs and medicinal ingredients are very important pharmaceuticals, helping patients to be treated effectively, and at the same time preventing abnormal problems and replenishing their health. health. On the other hand, medicine is also a "double-edged sword" causing exhaustion of people's health, in which the circulation of drugs and medicinal ingredients on the market of unknown origin, name and main use is one of the causes of this effect. Therefore, the current law has strict regulations on the circulation of drugs and medicinal ingredients to ensure the health of each of us. So is the law required to "register for circulation of drugs and medicinal ingredients"? Let's find out with MEDLAW to better understand this issue through the article below!

1. What are drugs and medicinal ingredients?

According to Clause 2, Article 2 of the 2016 Pharmacy Law, drug means a preparation containing active ingredients or medicinal herbs intended for human use, for the purposes of disease prevention, diagnosis, treatment, disease treatment, disease alleviation, and biological function adjustment. management of the human body, including chemical and pharmaceutical drugs, herbal medicines, traditional drugs, vaccines and biological products. Medicinal ingredients are ingredients that participate in the composition of a drug, including active ingredients, herbal ingredients, excipients, and capsule shells used in the drug manufacturing process as prescribed in Clause 3, Article 2 of the Law on Pharmacy 2016. 

2. Are medicinal drugs required to be registered for circulation?

According to Clause 1, Article 54 of the Law on Pharmacy 2016, drugs must be registered before being circulated in Vietnam, except for the following cases::

–  Medicines prepared according to prescriptions at pharmacies or manufactured and prepared at medical examination and treatment establishments.

–  Drugs without a certificate of registration of drug circulation in Vietnam are permitted to be imported and can only be imported not in excess of the quantity stated in the import permit in the case specified in Clause 2, Article 60 of the Law on Pharmacy 2016.

- Traditional medicine

+ Have traditional medicine medical examination and treatment establishments processed, prepared, weighed and loaded according to prescriptions and prescriptions for use and retailed according to prescriptions at such establishments; or

+ Because the hospital has the function of medical examination and treatment with traditional medicine at the provincial level or higher processing and preparing products are sold to medical treatment establishments that carry out other traditional medical care activities in the same province or centrally run city to treat patients at that facility.

3. Are medicinal ingredients required to be registered for circulation?

According to Clause 3, Article 54 of the Law on Pharmacy 2016, Medicinal ingredients must be registered before being sold in Vietnam, except for the following cases:

Medicinal ingredients are active ingredients for drug production according to drug registration dossiers already has a certificate of circulation in Vietnam;

Imported medicinal ingredients are pharmaceutical ingredients that do not have a certificate of drug circulation in Vietnam but are licensed for import, provided that they are only allowed to import not more than the quantity stated in the import permit in the following cases: after:

• To make registration forms, samples for testing, drug research, to participate in exhibitions and fairs;
• To produce drugs for export, drugs serving national defense and security requirements, disease prevention and control, and overcoming consequences of natural disasters.

Thus, the current legal regulations have strict and clear regulations on drugs and medicinal ingredients that must be registered before being circulated on the Vietnamese market. This contributes to the initiative in the management of drugs and medicinal ingredients.