Tasks of the Ministry of Health in management of pharmaceutical products and cosmetics in Vietnam

1. Formulate and promulgate or submit legislative documents, professional regulations and national technical regulations on pharmaceutical products and cosmetics, national criteria on medicine, Vietnamese Pharmacopeia and National Pharmacopoeia to competent authorities for promulgation;

2. Issue, re-issue, modify and revoke pharmacy practice certificates by attending and passing examinations; certificates of eligibility for pharmacy business for facilities manufacturing, importing or exporting drugs or medicinal ingredients, providers of drug/ medicinal ingredient storage services, providers of drug/ medicinal ingredient testing services, providers of clinical trial or bioequivalence study services for drugs; issue, renew, modify and revoke certificates of free sale of drug/ medicinal ingredients, licenses to import/ export drug/ medicinal ingredients, Good Manufacturing Practice (GMP) Certificates, Good Laboratory Practice (GLP) Certificates, Good Storage Practice (GSP) Certificate in accordance with laws; issue and nullify certificates of declaration of enterprise having drugstore chain meeting GPP standards;

3. Issue and revoke Cosmetics Good Manufacturing Practice (CGMP) Certificates; issue receiving numbers of applications for declaration of cosmetics products; issue receiving numbers of applications for declaration of compliance with good agricultural and collection practices for medicinal plants, and certificates of pharmaceutical products for traders in pharmaceutical products or cosmetics in accordance with laws;

4. Manage quality of drugs, medicinal ingredients and cosmetics; make decisions on suspension of sale or recall of drugs, medicinal ingredients and cosmetics in accordance with laws; cooperate with relevant authorities to prevent and fight against production or sale of counterfeit or poor quality drugs, medicinal ingredients and cosmetics as well as the smuggling of drugs, medicinal ingredients and cosmetics;

5. Organize pharmacovigilance and drug information system; issue certificates of approval for advertising contents for drugs;

6. Take charge and cooperate with Ministry of Finance and other ministries, ministerial-level agencies, the Government's affiliates and Provincial-level People’s Committees to manage the selling prices of drugs in accordance with laws; organize bulk purchasing of drugs at national level and take charge of drug-price negotiation in accordance with laws;

7. Instruct and inspect the use of drugs in rational, safe and effective manner;

8. Instruct and inspect the compliance with regulations on pharmaceutical products and cosmetics.

View more details at Decree No. 75/2017/NĐ-CP of Vietnam’s Government, effective from June 20, 2017.

- Ngoc Duyen -

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