Vietnam Pharmaceutical Licensing

Decree No. 163/2025/NĐ-CP applies to domestic and foreign agencies, organisations and individuals engaged in pharmaceutical activities in Vietnam. Certificates of eligibility for pharmaceutical business, individual pharmacy practice certificates, product marketing authorisations, and import/export or controlled-drug approvals are separate matters.

An initial application for a certificate of eligibility for pharmaceutical business must include an enterprise registration certificate or a legal document evidencing the lawful establishment of the organisation; this establishment document is not a pharmaceutical business licence. The official materials reviewed did not confirm generally applicable foreign ownership ratios, capital amounts or company forms. Foreign-invested projects must separately verify requirements with the investment, enterprise registration and health authorities.

— Verify separately the establishment document, certificate of eligibility for pharmaceutical business, individual practice certificate, product registration, and import/export or controlled-drug approvals.

Article 37 of the Law on Pharmacy allocates responsibilities by establishment category: the Ministry of Health is responsible for manufacturing and the central-level categories listed in Article 32; the Department of Health of the province or centrally governed city where the business premises are located is responsible for issuing, reissuing, amending and revoking certificates for wholesale and retail activities.

The DAV publishes information on the marketing authorisation of pharmaceuticals and active pharmaceutical ingredients. Product registration, certificates of eligibility for premises-based business, and individual practice certificates must be checked separately.

— Ministry of Health: manufacturing; Department of Health where the business is located: ordinary wholesale and retail; DAV: public product-registration information.

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Retail establishments include pharmacies, medicine counters, medicine cabinets at commune health stations, and establishments specialising in the retail of medicinal materials, medicinal herbs or traditional medicines. They must first obtain a certificate of eligibility for pharmaceutical business. Ordinary retail establishments must have premises, storage areas and equipment, technical documents and personnel, and comply with GPP.

Pharmaceuticals on the restricted-retail list require written approval from the Department of Health where the establishment is located; specially controlled drugs are subject to additional written approval and security requirements. The specialised retail of traditional medicines is subject to the specific scope set out in Article 69 and its implementing rules.

— Physical retail is conducted under the certificate; online retail is generally limited to non-prescription, non-controlled and non-restricted-retail pharmaceuticals.

Wholesale of pharmaceuticals and active pharmaceutical ingredients is a separate business category under the authority of the Department of Health where the business is located. Wholesale establishments must have premises, warehouses, storage equipment, transport vehicles, a quality management system, technical documents and personnel, and comply with GDP.

Specially controlled drugs require written approval in addition to the general requirements. The National Public Service Portal, citing Decree No. 163/2025/NĐ-CP, describes applicable controls such as separate or dedicated storage, locks, video surveillance and record-keeping.

— Ordinary wholesale requires GDP; controlled products additionally require written approval, security measures and traceability controls.

Manufacturing is a separate business category under the authority of the Ministry of Health. Manufacturing establishments must have premises, production workshops, testing laboratories, warehouses, support systems, equipment, a quality management system, technical documents and personnel, and comply with GMP.

Manufacturers must produce in accordance with the registered or declared process and quality standards, release only compliant products, and assume post-market monitoring and recall responsibilities. Traditional medicine manufacturing is subject to separate GMP, personnel and product rules.

— Manufacturing GMP, the certificate of eligibility for premises-based business, product registration, and cross-border permits must be considered separately.

A certificate of eligibility for pharmaceutical business is different from an individual pharmacy practice certificate. The professional person in charge of pharmaceutical activities and personnel in statutory roles must hold a practice certificate appropriate to the establishment; an establishment’s certificate does not mean that individuals automatically acquire the required qualifications.

Decree No. 163/2025/NĐ-CP requires foreign professional qualifications to be recognised as equivalent. Foreign documents must, where required, undergo consular legalisation, translation into Vietnamese and certification of the translator’s signature. Circular No. 31/2025/TT-BYT requires the list of currently practising certificate holders to be updated.

— Process establishment applications and individual practice-certificate applications separately, and keep records of changes in personnel.

The law adopts good practices linked to the type of business rather than a nationwide uniform floor area that this guide could summarise: GMP for manufacturing, GDP for wholesale, and GPP for retail. All three involve premises, facilities, quality systems, technical documentation and personnel.

Medicines and active pharmaceutical ingredients must be stored according to their labelled conditions; specially controlled medicines are also subject to security measures to prevent loss. Traditional medicinal materials and traditional medicines sold at specialist retail outlets are subject to separate requirements for premises, storage and traceability.

— GMP for manufacturing, GDP for wholesale, and GPP for retail; controlled products are additionally subject to security and record-keeping requirements.

For an initial application or a new application following revocation, the core documents are an application, the relevant technical documents, proof of business registration or lawful establishment, and a pharmacy practice certificate. Applications are submitted to the competent authority under Article 37.

A change in category, scope or location that alters the conditions requires an application for issuance; changes to the name, address, scope that does not alter the conditions, or professional manager’s information are handled as amendments. Issuance takes 30 days after receipt of a complete application; reissuance or amendment takes 20 days; reissuance due to an error by the authority takes 7 working days.

— After confirming the competent authority, submit the application, technical documents, proof of establishment and the corresponding practice certificate.

A Certificate of Eligibility for Pharmacy Business has no fixed validity period, but the premises, technical and personnel conditions must be assessed at least once every 3 years, or assessed on an unscheduled basis as prescribed.

This research has not verified a current fee schedule that can safely be applied across central and local authorities, initial and amendment applications, and GxP assessments; therefore, no amounts are stated.

— The certificate has no fixed validity period; conditions are assessed at least once every 3 years; confirm fees with the authority actually receiving the application.

An establishment must continuously meet the requirements, operate only within the categories, scope and locations stated on its certificate, and fulfil obligations including storage according to labels, retention of batch documentation, display of the certificate, updating personnel lists, and submitting annual and other required reports.

Ceasing operations, no longer meeting the requirements, unlawful issuance, or failure to operate for 12 consecutive months without notification may lead to revocation. Suspensions lasting more than six months or cessation of operations must be reported to the Ministry of Health or the Department of Health.

— Maintain GxP, the certified scope/location/personnel, traceability, reporting and recall systems.

A change in category, scope or location that alters the business conditions requires an application for issuance; changes to the name, address, scope that does not alter the conditions, or professional manager’s information are handled as amendments; loss, damage or an error by the authority is handled as reissuance.

The provisions reviewed in force do not state that a sale of shares, merger or handover automatically transfers a Certificate of Eligibility for Pharmacy Business. Before a transaction, separately verify changes to the entity, address, scope, personnel, product registrations and controlled-product approvals.

— A change in category, scope or location that affects the conditions requires an application for issuance; other specified changes are handled as amendments.

Medicines generally must be registered before being placed on the market. The Ministry of Health is responsible for issuing, renewing, amending and supplementing registrations. A premises’ Certificate of Eligibility for Pharmacy Business does not replace product marketing authorisation.

Medicines or active pharmaceutical ingredients without Vietnamese marketing authorisation may be imported only in statutory circumstances, subject to import permits and quantity limits; imports and exports of specially controlled medicines require permits and must not exceed the authorised quantities.

— Product registration, general cross-border pathways, permits for specially controlled medicines, and Certificates of Eligibility for Pharmacy Business are independent of one another.