Vietnam: A fine of up to 20 million VND for retailing drugs without a certificate of eligibility for pharmacy business

This is a notable provision in Decree 117/2020/ND-CP on penalties for administrative violations in medical sector in Vietnam.

No  Business  Eligibility  Certificate  When  Retailing  Drugs,  Decree  117/2020/ND-CP

Vietnam: A fine of up to 20 million VND for retailing drugs without a certificate of eligibility for pharmacy business (Illustration Photo)

Under Clause 5, Article 59 Decree 117/2020/ND-CP, a fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for buying or selling drugs/herbal ingredients in Vietnam:

- without a valid certificate of eligibility for pharmacy business;

- 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.

Thus, under the above regulation, entities retailing drugs without a certificate of eligibility for pharmacy business will be fined from 20,000,000 VND to 30,000,000 VND.

Additionally, this Decree also stipulates the following fines shall be imposed for buying or selling drugs/herbal 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/pharmaceutical starting materials which are not required to be registered as prescribed by Vietnamese law:

a) A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed for the violation involving goods worth less than VND 1.000.000;

b) A fine ranging from VND 2.000.000 to VND 3.000.000 shall be imposed for the violation involving goods worth from VND 1.000.000 to under VND 2.000.000;

c) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for the violation involving goods worth from VND 2.000.000 to under VND 5.000.000;

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

dd) A fine ranging from VND 7.000.000 to VND 10.000.000 shall be imposed for the violation involving goods worth from VND 10.000.000 to under VND 15.000.000;

e) A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for the violation involving goods worth from VND 15.000.000 to under VND 30.000.000;

g) A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for the violation involving goods worth from VND 30.000.000 to under VND 40.000.000;

h) A fine ranging from VND 20.000.000 to VND 25.000.000 shall be imposed for the violation involving goods worth from VND 40.000.000 to under VND 50.000.000;

i) A fine ranging from VND 25.000.000 to VND 30.000.000 shall be imposed for the violation involving goods worth from VND 50.000.000 to under VND 70.000.000;

k) A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for the violation involving goods worth from VND 70.000.000 to under VND 100.000.000;

l) A fine ranging from VND 40.000.000 to VND 50.000.000 shall be imposed for the violation involving goods worth VND 100.000.000 or more.

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

Ty Na

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