Fine of up to 100 million for act of Exporting controlled drugs without the export license in Vietnam

Fine of up to 100 million  for act of Exporting controlled drugs without the export license in Vietnam (Illustration)

Decree 117/2020/ND-CP stipulates thats a fine ranging from VND 40.000.000 to VND 50.000.000 shall be imposed for commission of one of the following violations in Vietnam:

- Storing drugs/pharmaceutical starting materials at a warehouse facility that fails to meet GSP requirements or at a location other than the one specified in the certificate of eligibility for pharmacy business, except cases of use of storage services;

- Only maintaining GSP compliance at level 3;

- Importing drugs/pharmaceutical starting materials with a quantity exceeding that written on the import license given by a competent authority;

- Failing to re-export all drugs/pharmaceutical starting materials imported under the import license for display at a medicinal, pharmaceutical or medical device exhibition or fair upon the end of the exhibition or fair;

- Exporting controlled drugs without the export license;

- Importing drugs/pharmaceutical starting materials whose shelf life contravenes regulations on remaining shelf life of drugs/pharmaceutical starting materials when they arrive at Vietnam’s port without obtaining permission from the Minister of Health;

- Failing to recall drugs/pharmaceutical starting materials at the request of a competent authority;

- Importing drugs/pharmaceutical starting materials beyond the scope specified in the certificate of eligibility for pharmacy business;

- Expanding the existing warehouse, making major repairs or changes in structure or floor plan of the warehouse, or changing the auxiliary system or principle of design or operation of utility systems that may affect storage requirements or conditions without submitting a report on such changes, accompanied by relevant technical documents as prescribed by law.

Additionally, according to Clause 4, Article 4 of Decree 117/2020/ND-CP, the fine amount mentioned above applies to individuals. Therefore, for the aforementioned violations, the fine amount for organizations will be double the fine for individuals.

Accordingly, from November 15, 2020, enterprises will be fined up to 100 million for exporting drugs requiring special control without an export license.

For more details on other fines, refer to Decree 117/2020/ND-CP, which comes into force in Vietnam from November 15, 2020.

Ty Na

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