What is the fine for Importing drugs/pharmaceutical starting materials subject to a recall notification in Vietnam?

What is the fine for Importing drugs/pharmaceutical starting materials subject to a recall notification in Vietnam? (Illustrative image)

Decree 117/2020/ND-CP stipulates that a fine ranging from VND 70.000.000 to VND 80.000.000 shall be imposed for commission of one of the following violations in Vietnam:

- Importing drugs/pharmaceutical starting materials without possessing a certificate of eligibility for pharmacy business or while business operation or the certificate of eligibility for pharmacy business is suspended;

- Importing drugs/pharmaceutical starting materials subject to a recall notification of a competent authority;

- Importing drugs/pharmaceutical starting materials without the import license or certificate of registration, except drugs/pharmaceutical starting materials which are not required to be registered or do not require the import license;

- Performing activities related to the distribution of drugs/pharmaceutical starting materials in Vietnam by an entity is entitled to import but not entitled to distribute drugs/pharmaceutical starting materials in Vietnam, except drugs and pharmaceutical starting materials it manufactures in Vietnam.

Accordingly, under the above regulations, the act of importing medicines, materials for making medicines that have been recalled by a competent state agency will be fined from 70,000,000 VND to 80,000,000 VND. However, this fine applies to individuals, while organizations in violation will be fined twice the amount applicable to individuals.

In addition, the Decree also stipulates a fine from 50,000,000 VND to 70,000,000 VND for any of the following acts:

- Using fraudulent documents in the approved application for drug/pharmaceutical starting material import license according to the conclusion given by the competent authority;

- Importing drugs/pharmaceutical starting materials manufactured at a location other than that specified in the approved application for the drug import license;

- Submitting an application for import license containing information on the drug/pharmaceutical starting material which is not based on research findings or the manufacturer’s actual production.

More details can be found in Decree 117/2020/ND-CP which comes into effect in Vietnam from November 15, 2020.

Ty Na

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