List of fines imposed on violation of drug retailers in Vietnam as of November 15, 2020

No.

Violations

Fines

Additional penalties

Remedial measures

1

Failing to meet quality standards as prescribed by competent authorities when selling herbal ingredients which have been preliminarily processed;

1,000,000 - 3,000,000 VND

None

None

2

 A pharmacist who directly engages in the drug retailing fails to possess a professional qualifications as prescribed by law;

3

Failing to use records or computers for managing the warehousing, dispatching, inventory, batch number, expiry date, origin of drugs and other relevant information as prescribed by law;

4

Trading drug in violation of quality regulations at level 3;

5

Failing to specify the drug name, content and expiry date when retailing drugs without secondary packages; failing to specify the dose and usage when selling drugs without a prescription;

6

Failing to retain all documents about each batch/shipment of drugs/ pharmaceutical starting materials for a period prescribed by law;

7

Failing to cooperate or obstructing the quality inspection agency in taking samples of drugs or pharmaceutical starting materials to serve quality inspection tasks.

8

Relocating the drug retailer’s premises at the same business location or expanding the premises or making major repairs or changes in structure of the premises without submitting a report on such changes, accompanied by relevant technical documents as prescribed by law;

3,000,000 VND - 5,000,000 VND

Operations shall be suspended for a fixed period of 01 - 03 months

None

9

 Failing to provide a separate area for displaying products other than drugs or failing to put a notice indicating that "sản phẩm này không phải là thuốc" (“This is not a drug”) at the separate area for cosmetics, functional foods and medical devices as prescribed by law;

None

10

Trading drug in violation of quality regulations at level 2.

11

Failing to recall drugs/herbal ingredients at the request of a competent authority;

5,000,000 VND - 10,000,000 VND

None

None

12

Failing to have a separate room for making extemporaneous preparations or failing to have a separate area for washing preparation devices if preparing drugs according to prescriptions;

13

Failing to have a storage facility which has been registered by the drug retailer, or storing drugs against the storage conditions specified in the drug labels or against GPP (Good pharmacy practices) requirements;

14

 Storing or retailing drugs beyond the business scope specified in the certificate of eligibility for pharmacy business, drugs that belong to a national target program, drugs as emergency aid and other drugs banned from selling;

15

Selling vaccines or selling prescription drugs without a prescription presented;

Operations shall be suspended for a fixed period of 06 - 09 months

16

 Failing to submit reports on GPP compliance as prescribed by law;

None

17

Failing to have appropriate IT equipment, apply IT, make network connection or control origin, prices and sources of drugs bought and sold as prescribed by law, except herbal ingredient retailers;

The certificate of eligibility for pharmacy business shall be suspended for a fixed period of 01 - 02 months

18

Failing to transmit information about the drug purchase and sale, and drug quality between suppliers and customers; failing to transmit information to relevant regulatory authorities at their request, except herbal ingredient retailers;

19

Only maintaining GPP compliance at level 3.

Operations shall be suspended for a fixed period of 06 - 09 months

20

Buying or selling drugs for clinical trial;

10,000,000 VND - 20,000,000 VND

None

None

21

Buying or selling drugs manufactured or prepared according to prescriptions for use within health facilities, unless permitted by law;

The pharmacy practicing certificate and certificate of eligibility for pharmacy business shall be suspended for a fixed period of 01 - 03 months

22

Buying or selling modern drugs prepared according to prescriptions from other drugstores;

23

Buying or selling drugs on the list of drugs restricted from retailing without obtaining permission as prescribed by law;

24

Failing to adopt isolation measures or put the following drugs/herbal ingredients at quarantine areas: substandard drugs/herbal ingredients; drugs/herbal ingredients subject to a recall notification of a competent authority; expired drugs/herbal ingredients; drugs/herbal ingredients of unknown origin;

None

25

Trading drug in violation of quality regulations at level 1.

26

Buying or selling drugs/herbal ingredients without a valid certificate of eligibility for pharmacy business;

20,000,000 VND - 30,000,000 VND

None

All drugs/herbal ingredients shall be destroyed and the violating entity is compelled to return any benefits illegally obtained from the commission of one of the violations

27

Buying or selling drugs/herbal ingredients at a location other than the one specified in the issued certificate of eligibility for pharmacy business; or

The pharmacy practicing certificate shall be suspended for a fixed period of 03 - 06 months

The violating entity is compelled to return any benefits illegally obtained from the commission of one of the violations

28

Buying or selling drugs/herbal ingredients while business operation or the certificate of eligibility for pharmacy business is suspended.

Operations shall be suspended for a fixed period of 06 - 09 months

29

The following fines shall be imposed for buying or selling drugs/herbal ingredients which are subject to recall decisions issued by competent authorities, which have been 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 law:

30

Violation involving goods worth less than 1.000.000 VND ;

1,000,000 - 2,000,000 VND

The pharmacy practicing certificate shall be suspended for a fixed period of 03 - 06 months

All drugs/herbal ingredients shall be destroyed and the violating entity is compelled to return any benefits illegally obtained from the commission of one of the violations

31

Violation involving goods worth from 1.000.000 to under 2.000.000 VND ;

2,000,000 - 3,000,000 VND

32

Violation involving goods worth from 2.000.000 to under 5.000.000 VND ;

3,000,000 - 5,000,000 VND

33

Violation involving goods worth from 5.000.000 to under 10.000.000 VND ;

5,000,000 - 7,000,000 VND

34

Violation involving goods worth from 10.000.000 to under 15.000.000 VND ;

7,000,000 - 10,000,000 VND

35

Violation involving goods worth from 15.000.000 to under 30.000.000 VND ;

10,000,000 - 15,000,000 VND

36

Violation involving goods worth from 30.000.000 to under 40.000.000 VND ;

15,000,000 - 20,000,000 VND

37

Violation involving goods worth from 40.000.000 to under 50.000.000 VND ;

20,000,000 - 25,000,000 VND

38

Violation involving goods worth from 50,000,000 to under 70,000,000 VND

25,000,000 - 30,000,000 VND

39

Violation involving goods worth from 70,000,000 to under 100,000,000 VND

30,000,000 - 40,000,000 VND

40

Violation involving goods worth 100,000,000 VND or more

40,000,000 - 50,000,000 VND