Summary of fines for violations against regulations on pharmacy business establishments and eligibility requirements to run pharmacy business in Vietnam

Summary of fines for violations against regulations on pharmacy business establishments and eligibility requirements to run pharmacy business in Vietnam (Illustrative image)

At Article 53 of Decree 117/2020/ND-CP, regulations on administrative penalties for violations against regulations on pharmacy business establishments and eligibility requirements to run pharmacy business in Vietnam are stipulated as follows:

1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:

- A mobile drug retailer fails to meet eligibility requirements set by law;

- A mobile drug retailer fails to send a written notification to the Department of Health of the province where the mobile retailer will operate.

2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed upon a business establishment that has a drug cabinet for failing to meet one of eligibility requirements set by law;

3. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for forging any of the required documents in the application for listing of business establishment that has a drug cabinet.

4. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for failing to adopt isolation measures or put the following drugs/pharmaceutical starting materials at quarantine areas, except the case prescribed in Point dd Clause 4 Article 59 hereof:

- Substandard drugs or pharmaceutical starting materials;

- Drugs or pharmaceutical starting materials subject to a recall notification of a competent authority;

- Expired drugs or pharmaceutical starting materials;

- Drugs or pharmaceutical starting materials of unknown origin.

Additionally, the regulations stipulate supplementary penalties and remedial measures for violations regarding pharmaceutical business establishments and their conditions as follows:

Addit penalties:

- Business operations involving the violation in Point a Clause 1 or Clause 2 of this Article shall be suspended for a fixed period of 01 – 03 months;

- Business operations involving the violation in Clause 3 of this Article shall be suspended for a fixed period of 06 – 12 months.

Remedial measures: Mandatory destruction of all medicines and raw materials for making medicines for violations under Item 4, except where the competent state authority permits re-export or remediation as prescribed by law.

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

Ty Na

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