Heavy fine for Failing to submit reports on GSP in Vietnam

Heavy fine for Failing to submit reports on GSP in Vietnam (Illustrative photo)

According to the provisions in Clause 2, Article 60 of Decree 117/2020/ND-CP, a fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations in Vietnam:

- Failing to submit reports on GSP (Good storage practices) compliance as prescribed by law;

- Failing to send a written notification to the Ministry of Health of the wholesaler that distributes drugs/pharmaceutical starting materials imported into Vietnam by an entity that is entitled to import but not entitled to distribute drugs/pharmaceutical starting materials in Vietnam before starts to sell or stops selling drugs to that wholesaler;

- Failing to retain documents concerning the drug/pharmaceutical starting material shipment for a period prescribed by law;

- Selling drugs that belong to a national target program, drugs as emergency aid and other drugs banned from selling;

- Exporting 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;

- Exporting drugs/pharmaceutical starting materials that are subject to a recall notification as prescribed by law in Vietnam;

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

- Exporting herbal ingredients included in the list of controlled rare and special herbs without obtaining permission from a competent authority in Vietnam.

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

Ty Na

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