Vietnam: Regulations on facilities specialized in testing drugs and medicinal ingredients under Law on Pharmacy 2016

Vietnam: Regulations on facilities specialized in testing drugs and medicinal ingredients under Law on Pharmacy 2016 (Illustrative image)

Article 104 of the Law on Pharmacy 2016 stipulates that the facilities specialized in testing drugs and medicinal ingredients (hereinafter referred to as​ drug-testing facilities) in Vietnam include:

- State-owned drug-testing facilities:

- Providers of drug-testing services;

- Laboratories of pharmaceutical-trading establishments.

State-owned drug-testing facilities in Vietnam have the responsibility to:

- Test the quality of drugs, medicinal ingredients and primary packages of drugs;

- Test the quality and assess quality standards applied to drugs, medicinal ingredients and primary packages of drugs at the request of the Ministry of Health;

- Propose technical measures to the Minister of Health for enhancement of drug quality control appropriate for current level of socio-economic development;

- Ensure truthfulness and objectivity in testing drugs, medicinal ingredients, and primary packages of drugs;

- Take responsibility for the test results produced.

Additionally, providers of drug testing services in Vietnam have the following responsibilities:

- Have a Certificate of eligibility for pharmacy business and adhere to the type, scope, and location of business written therein;

- Maintain the fulfillment of conditions for pharmacy business specified in this law throughout the business operation;

- Pay compensation for organizations and individuals that suffer damage caused by the pharmacy business establishment;

- Comply with decisions of competent authorities on supply of drugs/medicinal ingredients in case of an epidemic or disaster;

- Report to the Ministry of Health or Provincial Department of Health and fulfill the obligations in case of suspension for 06 months or longer or shutdown;

- Notify, update the list of practitioners having pharmacy practice certificates to the competent authority as prescribed by the Minister of Health;

- Openly post the pharmacy practice certificates and Certificate of eligibility for pharmacy business in the premises;

- Submit annual and ad hoc reports to competent pharmacy authorities;

- Retail documents about each batch/shipment of drugs/medicinal ingredients for at least 01 years from their expiration dates;

- Store drugs/medicinal ingredients under the conditions written on the labels;

- Ensure truthfulness and objectivity in testing drugs/medicinal ingredients;

- Take responsibility for the test results it produced.

The laboratory of a pharmacy business establishment shall test the quality of its drugs, medicinal ingredients, and primary packages of drugs.

Details can be found at Law on Pharmacy 2016 effective from January 01, 2017.

Ty Na

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