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CONDITIONS FOR IMPORTING DRUGS INTO VIETNAM

Medicine is a special commodity, directly related to the health and life of everyone. The State currently has strict regulations on drug import activities. However, many organizations and individuals currently do not understand the drug import process, leading to unnecessary losses. In this article, Doanh Tri Law Firm will shed light on this issue.

I. Legal basis

- Commercial Law 2005;

- Law on Pharmacy 2016.

II. What is drug import?

Theoretically, import is understood as an international trading business. It is the exchange of goods between countries in the world with the principle of parity exchange for currency as a broker and usually for a certain period of time. Importing is not a single act of trade, but a system of trade relations in an economy with both internal and external organizations.

Pursuant to Article 28 of Commercial Law 2005: Import of goods means that goods are brought into the Vietnamese territory from abroad or from a special area located in the territory of Vietnam, which is considered a customs area. separately in accordance with the law.

Therefore, drug import means the introduction of drugs into the Vietnamese territory from abroad or from a special area located in the Vietnamese territory which is considered a separate customs area according to the provisions of law.

Currently, Vietnam stipulates 10 lists of imported and exported drugs with commodity codes identified as follows:

- List of toxic drugs and toxic ingredients for export and import drugs;

- The list of import-export drug ingredients that are narcotic active ingredients;

- List of raw materials for making import and export drugs that are psychotropic active ingredients;

- The list of import-export drug materials that are precursors used to make drugs;

- The list of imported and exported drugs and pharmaceutical substances on the List of substances banned from use in a number of industries and fields;

- The list of import-export drug materials that are radioactive substances used in the medical industry;

- List of import-export medicinal ingredients that are pharmaceutical ingredients and semi-finished medicinal product;

- The list of drugs contains only 1 ingredient of imported and exported pharmaceutical ingredients;

- List of drugs in the form of import-export combination;

- The list of import and export cosmetics;

According to Article 2 of the Law on Pharmacy 2016, drugs are understood as: “Drug is a preparation containing pharmaceutical substances or medicinal herbs for use in humans for the purposes of disease prevention, diagnosis, treatment, treatment, disease relief, adjustment of physiological functions of the human body, including chemical drugs pharmaceuticals, herbal medicines, traditional medicines, vaccines and biological products.”

III. Applicable objects

- Drug production and trading enterprises established in accordance with the law are recognized by the Ministry of Health as fully qualified and eligible for drug import and export business.

- Manufacturing and trading enterprises of all economic sectors established in accordance with the law of Vietnam have the Certificate of business registration of drugs for prevention and treatment of human diseases.

- Import-export business rights of foreign-invested enterprises, business co-operation parties, branches of foreign traders in Vietnam.

IV. Conditions for importing drugs

Regarding the pharmacy practice certificate, the person granted the pharmacy practice certificate must have a professional diploma or certificate suitable to the requirements of the drug exporting or importing enterprise, specifically:

- A person who is granted a pharmacy practice certificate by an exporter or importer who meets the following conditions is considered a professional pharmacy manager of a drug importer: Drug manufacturing enterprises and drug wholesalers having a License having a certificate of eligibility for drug business and having a drugstore meeting the standards of Good Storage Practices, being allowed to import drugs in accordance with the pharmacy law, the regulations of the Ministry of Health and relevant laws involved.

- A person who is granted a pharmacy practice certificate by a drug-trading establishment is considered a professional pharmacy manager of a drug-exporting establishment.

- Facilities, techniques, and qualified personnel necessary for each form of drug business;

- The pharmacy manager has been granted a pharmacy practice certificate suitable to the business form.

- Facilities, techniques, and qualified personnel necessary for each form of drug business;

- The pharmacy manager has been granted a pharmacy practice certificate suitable to the business form.

- Drug manufacturers and wholesalers that have a Certificate of eligibility for drug business and have a drug warehouse meeting the standards on Good Preservation Practices are allowed to import drugs in accordance with the pharmaceutical law.

The above information is about the ‘Conditions for importing drugs into Vietnam.' For more information and advice on this issue, please contact Doanh Tri Law Firm directly via:

Hotline: (+84) 911.233.955 - (024) 6293 8326

Email: contact@luatdoanhtri.vn

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