What are tasks and powers of the Ministry of Health of Vietnam regarding pharmaceutical products and cosmetics?

What are tasks and powers of the Ministry of Health of Vietnam regarding pharmaceutical products and cosmetics?

Pursuant to Clause 9 Article 2 of the Decree 95/2022/NĐ-CP stipulating tasks and powers of the Ministry of Health of Vietnam regarding pharmaceutical products and cosmetics as follows:

a) Formulate and promulgate or request competent authorities to promulgate specialized regulations and national technical regulations on pharmaceutical products and cosmetics; national criteria on medicine; promulgate and update Vietnamese Pharmacopoeia and Vietnamese National Drug Formulary;

b) Promulgate the list of drugs and active ingredients included in the list of banned substances in some fields and sectors; the list of controlled drugs and medicinal materials; the list of rare drugs; the list of essential drugs; the list of OTC drugs; the list of domestically manufactured drugs to meet medical treatment, drug pricing and supply capacity requirements; the list of drugs supplied through bidding; the list of drugs supplied through centralized bidding; and the list of drugs supplied through price negotiation;

c) Issue, extend, modify and revoke marketing authorizations of drugs and medicinal materials; license to import/export drugs, medicinal materials and primary packages thereof; issue certificate of pharmaceutical products to drug traders in accordance with regulations of law; Approve order forms for narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials which are narcotic active ingredients, psychotropic active ingredients or precursors;

d) Issue, re-issue, modify and revoke pharmacy practicing certificates by attending and passing examinations; certificates of eligibility for pharmacy business of drug/medicinal material manufacturers, importers or exporters, providers of drug/medicinal material storage, testing, clinical trial or bioequivalence study services; GMP (Good Manufacturing Practices) certificates, GLP (Good Laboratory Practices) certificates, GSP (Good Storage Practices) certificates and GCP (Good Clinical Practices) certificates in accordance with laws; announce the list of foreign drug/medicinal material manufacturers and traders applied for supply of drugs/medicinal materials in Vietnam; assess the conformity with GMP requirements by foreign drug/medicinal material manufacturers when they apply for supply of drugs/medicinal materials in Vietnam in accordance with regulations of law;

dd) Issue and revoke receipt numbers of written declarations of imported cosmetic products; approve changes in contents of such written declarations; issue, re-issue, modify and revoke CGMP (Cosmetic Good Manufacturing Practices) certificates in accordance with regulations of law;

e) Manage quality of drugs, medicinal materials and cosmetics; make decisions on suspension of sale or recall of drugs, medicinal materials and cosmetics in accordance with regulations of law; cooperate with relevant authorities to prevent and fight against production or sale of counterfeit, poor quality and unknown origin drugs, medicinal materials and cosmetics as well as the smuggling of drugs, medicinal materials and cosmetics in accordance with regulations of law;

g) Organize the drug information and pharmacovigilance system; issue, re-issue and modify certificates of drug information; certificates of approval of advertising contents for drugs in accordance with regulations of law;

h) Play the leading role and cooperate with Ministry of Finance of Vietnam and other ministries, ministerial agencies, Governmental agencies and Provincial People’s Committees to manage and announce the selling prices of drugs in accordance with regulations of law;

i) Provide guidelines for bidding for purchase of drugs serving medical prevention, examination and treatment with funding from state budget, health insurance fund and other lawful funding sources of health facilities; organize the national centralized drug procurement and play the leading role in negotiating drug prices in accordance with regulations of law;

k) Direct, instruct, organize and inspect the use of drugs in a rational, safe and effective manner;

l) Direct, instruct, organize and inspect the implementation of law regulations on pharmaceutical products and cosmetics.

What are tasks and powers of the Ministry of Health of Vietnam regarding food safety?

Pursuant to Clause 10 Article 2 of the Decree 95/2022/NĐ-CP stipulating tasks and powers of the Ministry of Health of Vietnam regarding food safety as follows:

a) Play the leading role in formulating and promulgating national technical regulations on food products within the scope of its management; promulgate national technical regulations or regulations on safety limits of food product groups at the request of supervisory ministries; promulgate the list of food additives;

b) Formulate and request competent authorities to promulgate regulations on food safety conditions to be satisfied by manufacturers and traders of functional foods, natural mineral water, bottled water, edible ice, micronutrients, food additives, food flavorings, food processing aids, devices and materials for directly packaging or storing foods; industrial kitchens, restaurants of hotels, resorts, other restaurants, food and beverage trading establishments and street food vendors;

c) Play the leading role in disseminating information and knowledge and educate about laws on food safety within the scope of its management;

d) Play the leading role and cooperate with relevant ministries and regulatory authorities in building an alert system on food safety incidents; providing specific provisions on statement of food safety incidents; organizing the supervision, analysis of food safety risks, prevention, investigation and cooperation in preventing food poisoning as well as responding to food safety risks within the scope of its management;

dd) Manage the compliance with regulations on food safety during the production, preparation, processing, preservation, transportation, import, export and trading in the following food products, including: food additives, food processing aids, bottled water, natural mineral water, edible ice, micronutrients, functional foods and other foods in accordance with regulations of law; take responsibility for food safety management of devices and materials for directly packaging or storing foods during the production, processing and trading of food products in the fields within the scope of its management;

e) Organize receipt and management of applications, and issuance of certificates of registered product declaration with regard to dietary supplements, mixed food additives with new effects and food additives which are not included in the list of permitted food additives or are intended for use in foods other than those prescribed by the Ministry of Health of Vietnam; issuance of certificates of approval of advertising contents for dietary supplements; issuance of certificates of free sale for food products in the fields within the scope of its management; issuance of health certificates and other certificates for exported food products in accordance with regulations of law;

g) Consider issuing certificates of fulfillment of food safety requirements to eligible manufacturers and traders of mixed food additives with new effects and food additives which are not included in the list of permitted food additives or are intended for use in foods other than those prescribed by the Ministry of Health of Vietnam; issue and re-issue GMP certificates for dietary supplements in accordance with regulations of law;

h) Appoint food testing laboratories serving the performance of state management tasks and reference testing laboratories within the scope of its management; appoint laboratories that run tests serving arbitration and giving final conclusions in case of discrepancies in testing results given by various laboratories;

i) Appoint regulatory authorities in charge of performing food safety inspection of imported foods products within the scope of its management;

k) Direct, instruct, organize and inspect the implementation of legislative documents, national standards, and national technical regulations on food safety within the scope of its management;

l) Prepare periodical and ad hoc reports on food safety management on the basis of supervising and consolidating reports submitted by supervisory ministries and local governments.

What are tasks and powers of the Ministry of Health of Vietnam regarding population and reproductive health?

Pursuant to Clause 11 Article 2 of the Decree 95/2022/NĐ-CP stipulating tasks and powers of the Ministry of Health of Vietnam regarding population and reproductive health as follows:

a) Formulate and request competent authorities to promulgate policies on population, including: population size, structure and quality;

b) Formulate and promulgate or request competent authorities to promulgate national standards on population, family planning, reproductive health and health of the elderly; formulate and promulgate criteria and indexes on population, reproductive health and health of the elderly; specialized regulations and national technical regulations on population and family planning services, reproductive health services and community-based healthcare services for the elderly;

c) Consider giving permission to eligible providers of consulting services on population, family planning and community-based healthcare services for the elderly in accordance with regulations of law;

d) Appraise and issue decisions on certification of health facilities' eligibility to conduct in vitro fertilization and surrogacy procedures for humanitarian purposes; consider giving permission to health facilities to conduct sex reassignment procedures;

dd) Direct, instruct and inspect the implementation of legislative documents, specialized regulations, national technical regulations, policies, programs and/or projects on population, family planning, reproductive health services and community-based healthcare services for the elderly.

Best regards!