From November 15, what is the fine for failing to obtain a certificate of eligibility for pharmacy business in Vietnam?

Recently, the Government of Vietnam issued Decree 117/2020/ND-CP on penalties for administrative violations in medical sector in Vietnam.

  not  having  a  Certificate  of  Eligibility  for  Pharmaceutical  Business  Conditions,  Decree  117/2020/ND-CP

From November 15, what is the fine for failing to obtain a certificate of eligibility for pharmacy business in Vietnam? (Illustrative photo)

Under Decree 117/2020/ND-CP, a fine ranging from VND 40.000.000 to VND 60.000.000 shall be imposed for buying or selling drugs/medicinal ingredients:

- without a valid certificate of eligibility for pharmacy business in Vietnam;

- at a location other than the one specified in the issued certificate of eligibility for pharmacy business; or

- while business operation or the certificate of eligibility for pharmacy business is suspended.

Furthermore, the following fines shall be imposed for buying or selling drugs/medicinal ingredients that are subject to recall decisions issued by competent authorities, which have expired, or which are not issued with the import license or certificate of registration, except drugs/medicinal ingredients which are not required to be registered as prescribed by Vietnamese law:

- A fine ranging from VND 5.000.000 to VND 7.000.000 shall be imposed for the violation involving goods worth less than VND 5.000.000;

- A fine ranging from VND 7.000.000 to VND 10.000.000 shall be imposed for the violation involving goods worth from VND 5.000.000 to under VND 10.000.000;

- A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for the violation involving goods worth from VND 10.000.000 to under VND 20.000.000;

- A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for the violation involving goods worth from VND 20.000.000 to under VND 30.000.000;

- A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for the violation involving goods worth from VND 30.000.000 to under VND 40.000.000;

- A fine ranging from VND 40.000.000 to VND 50.000.000 shall be imposed for the violation involving goods worth from VND 40.000.000 to under VND 50.000.000;

- A fine ranging from VND 50.000.000 to VND 60.000.000 shall be imposed for the violation involving goods worth from VND 50.000.000 to under VND 60.000.000;

- A fine ranging from VND 60.000.000 to VND 70.000.000 shall be imposed for the violation involving goods worth from VND 60.000.000 to under VND 70.000.000;

- A fine ranging from VND 70.000.000 to VND 80.000.000 shall be imposed for the violation involving goods worth from VND 70.000.000 to under VND 80.000.000;

- A fine ranging from VND 80.000.000 to VND 90.000.000 shall be imposed for the violation involving goods worth from VND 80.000.000 to under VND 100.000.000;

- A fine ranging from VND 90.000.000 to VND 100.000.000 shall be imposed for the violation involving goods worth VND 100.000.000 or more.

More details can be found in Decree 117/2020/ND-CP effective from November 15, 2020.

Thuy Tram

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