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Drug Import & Export in Vietnam

Two regimes — ordinary commercial trade in drugs with valid marketing authorisation, and the special import-export of drugs without registration number — under Pharmacy Law Article 60 and new Article 53a (added by Law 44/2024/QH15), Decree 163/2025/NĐ-CP Chapter IV, the Customs Law 54/2014/QH13, and the 1961 Hague Apostille Convention from 11 September 2026.

Overview

Drug import and export in Vietnam runs on two regimes that share one umbrella license but follow different rules. Drugs with a valid Vietnamese marketing authorisation (số đăng ký lưu hành) are imported and exported as ordinary commercial goods, subject to standard documentary, customs and quality controls. Drugs without a Vietnamese registration number — needed for an individual patient, an outbreak response, a clinical trial, or a similar non-routine purpose — require a special-import permit under Article 60 of the Pharmacy Law and the dedicated procedure in Chapter IV of Decree 163/2025/NĐ-CP. Both regimes require the importing or exporting establishment to hold a Giấy chứng nhận đủ điều kiện kinh doanh dược (GCN ĐĐKKDD) for the relevant form of pharmacy business; see the Medibase Distribution & Retail page for the umbrella framework.

Scope of this page:

  • The two regimes — commercial trade in MA-holding drugs versus special-import / special-export of drugs without registration.
  • Authority structure: DAV (Cục Quản lý Dược) for import licensing and the foreign-supplier register; Sở Y tế for controlled-substance overlay where applicable; Tổng cục Hải quan (General Department of Vietnam Customs) for clearance.
  • The post-1 July 2025 legal stack: Pharmacy Law Article 60 + new Article 53a, Decree 163/2025 Chapter IV, Circular 12/2025 on registration, Circular 28/2025 on GMP, and the Customs Law.
  • Documentary requirements: CPP / FSC, foreign-manufacturer recognition (FMR), and the shift from consular legalisation to apostille from 11 September 2026.
  • Special-import categories under Decree 163/2025 (Articles 54, 55, 56, and the urgent-need provision).
  • Drug export — Vietnamese-manufactured drugs and the DAV-issued CPP / FSC procedure.
  • Foreign-invested enterprise (FIE) scope under new Article 53a.
  • Customs procedure, bonded warehouse, and sanctions.

Authority structure:

  • Bộ Y tế leads the regime through the Cục Quản lý Dược (Drug Administration of Vietnam — DAV), which issues import licences (both ordinary and special), CPP / FSC for exports, and maintains the public register of foreign manufacturers and suppliers authorised to supply drugs and pharmaceutical starting materials into Vietnam.
  • Sở Y tế cấp tỉnh participates in the licensing chain for controlled-substance imports under Decree 163/2025 Article 71 (15-day issuance timeline) and for the retail and dispensing side of the supply chain.
  • Tổng cục Hải quan (General Department of Vietnam Customs, Ministry of Finance) clears import shipments at designated drug-import ports against the DAV import licence and the specialised drug-customs dossier defined in Decree 163/2025 Chapter IV.

Legal stack (current from 1 July 2025):

  • Pharmacy Law 105/2016/QH13 — Article 60 (the only article in the Law dedicated to import-export of drugs and pharmaceutical starting materials; located in Chương V Mục 2 on circulation, not in a stand-alone import-export chapter) and new Article 53a (added by Law 44/2024/QH15, defining the rights of foreign-invested pharmaceutical enterprises).
  • Decree 163/2025/NĐ-CP — Chapter IV "Xuất khẩu, nhập khẩu thuốc, nguyên liệu làm thuốc" consolidates the import-export operational rules into a single instrument, replacing the NĐ 54/2017 + NĐ 88/2023 stack. Confirmed articles inside the chapter include Article 50 (export of special-control drugs including personal luggage, humanitarian aid and return of unused stock), Articles 54–56 (special-import categories), Article 71 (15-day timeline for special-control drug imports), and the Articles in the 91–93 range governing the foreign-manufacturer / foreign-supplier register and GMP-status updates .
  • Circular 12/2025/TT-BYT — marketing-authorisation registration; the prerequisite for ordinary commercial import of finished drugs.
  • Circular 28/2025/TT-BYT — Good Manufacturing Practice (GMP), replacing TT 35/2018/TT-BYT; defines the standard against which foreign manufacturers are recognised.
  • Circular 11/2025/TT-BYT — cross-cutting amendment of GPP, GDP and GSP (relevant where the importer also operates as a wholesaler or storage-service provider).
  • Customs Law 54/2014/QH13 (in force 1 January 2015) and its implementing decrees and circulars on specialised customs procedure for pharmaceuticals.

Commercial drug import (drugs with valid Vietnamese MA): Imports of finished drugs and pharmaceutical starting materials that already hold a valid Vietnamese marketing authorisation follow ordinary commercial customs procedures, with the pharmaceutical overlay defined in Decree 163/2025 Chapter IV. The importer must hold a GCN ĐĐKKDD for the import form of pharmacy business (issued by DAV) and present, at customs, the shipment dossier including: the valid marketing authorisation or import licence reference; the manufacturer's batch certificate of analysis; the Certificate of Pharmaceutical Product (CPP) issued by the exporting-country authority and legalised in accordance with the rules below; evidence that the foreign manufacturer is on the DAV-published recognised-supplier register; and the remaining-shelf-life compliance documentation. Specialised drug import ports apply.

Special-import permit (drugs without Vietnamese registration number): Decree 163/2025 Chapter IV defines the categories of drugs that may be imported without a Vietnamese MA, each with its own dossier, evaluation pathway and validity:

  • Article 54 — drugs meeting a special treatment need: individual-patient need, rare-disease therapy, compassionate-use, where no suitable registered alternative exists.
  • Article 55 — drugs whose active substance is not yet registered in Vietnam, or traditional-medicine substances being imported for first use in Vietnam.
  • Article 56 — drugs with active substance already registered but with supply insufficient to meet demand; or traditional-medicine substances previously used but with current supply insufficient.
  • Urgent-need provision — drugs required for national defence, security, prevention and control of disease outbreaks, or remediation of disaster or calamity.
  • Non-commercial imports — registration sample, testing sample, clinical-trial use, exhibition or trade-fair display, scientific research, humanitarian aid or donation, and personal luggage within statutory limits.
  • Special-control drugs with valid MA — Article 71 sets a 15-day issuance timeline; the issuing authority is DAV (Bộ Y tế) for ordinary controlled substances and Sở Y tế cấp tỉnh for the substances within the provincial-DOH scope.

Drug export: Vietnamese-manufactured drugs holding a Vietnamese GMP certificate and a valid MA may be exported under ordinary commercial customs procedure. Where the destination country requires a Certificate of Pharmaceutical Product or Free Sale Certificate, the manufacturer or MA holder applies to DAV, which issues both under DAV procedure QT.ĐT.02.01 (CPP requires a valid Vietnamese MA and current GMP; FSC requires a valid MA). Export of special-control drugs is regulated separately by Decree 163/2025 Article 50, which covers commercial export, export as humanitarian aid, return of unused stock to the manufacturer, and personal-luggage export within statutory limits. There is no general export licence requirement beyond CPP / FSC for routine commercial export of MA-holding drugs.

Apostille milestone (effective 11 September 2026): Vietnam deposited its instrument of accession to the 1961 Hague Convention Abolishing the Requirement of Legalisation for Foreign Public Documents on 31 December 2025. The Convention enters into force for Vietnam on 11 September 2026. Until that date, foreign-issued CPPs and similar public documents submitted in Vietnamese drug-import procedures must continue to be legalised by Vietnamese consular missions in the issuing country. From 11 September 2026, an apostille issued by the competent authority of a Convention member state replaces consular legalisation for documents originating from that state; documents from non-member states continue to require consular legalisation. A Ministry of Health or DAV transition notice clarifying the pharmaceutical-specific implementation is expected during 2026.

Foreign-invested enterprise scope (Article 53a — new): Article 53a of the Pharmacy Law, added by Law 44/2024/QH15, defines and limits the rights of foreign-invested pharmaceutical enterprises (FIEs). FIEs may import drugs, sell imported drugs to licensed wholesalers and to defined hospitals and treatment centres, and sell drugs they manufacture, contract-manufacture, or receive technology transfer for in Vietnam. FIEs may not engage in stand-alone wholesale storage or transport unrelated to their own sales, and may not engage in direct retail — preserving the WTO-commitment restriction. Foreign sponsors typically operate the import-and-distribute chain through a Vietnamese-owned wholesaler or distributor partner.

Foreign manufacturer recognition (FMR) and supplier register: Imported finished drugs and pharmaceutical starting materials must originate from a foreign manufacturing site recognised by DAV. DAV maintains the public list of recognised foreign manufacturers and suppliers — "Danh sách cơ sở sản xuất, kinh doanh thuốc, nguyên liệu làm thuốc nước ngoài đăng ký cung cấp thuốc, nguyên liệu làm thuốc vào Việt Nam" — on the DAV portal (see Resources). The legal basis under the new regime is Decree 163/2025/NĐ-CP, Chapter IV, in the Articles 91–93 range governing GMP-status updates and the responsibilities of foreign registrants. Medibase mirrors a search-friendly view of the DAV foreign-supplier notices at /search/foreign-drug-importers/.

Customs procedure and sanctions:

  • Customs declaration follows the Customs Law 54/2014/QH13. Drugs are typically classified under HS Chapter 30. The specialised drug-customs dossier — comprising the DAV import licence or MA reference, the manufacturer batch certificate, the legalised or apostilled CPP, evidence of recognised foreign-supplier status, and the shelf-life conformity — is presented at clearance. Bonded warehouse arrangements may apply for shipments awaiting completion of administrative requirements.
  • Administrative penalties: Decree 117/2020/NĐ-CP (healthcare sector) as amended by Decree 124/2021/NĐ-CP covers import-without-licence and counterfeit-drug administrative breaches. Decree 128/2020/NĐ-CP (customs sector) covers customs procedure violations including forged documents.
  • Criminal: Penal Code 2015 Article 194 — manufacture or trade in counterfeit medicines — carries 2–7 years and up to life-imprisonment or capital sentences in aggravated cases.

Key documents

Pharmacy Law:

  • Law on Pharmacy 105/2016/QH13 — Article 60 (only import-export article in the Law; located in Chương V Mục 2 on circulation) and new Article 53a (added by Law 44/2024/QH15, defining FIE pharma rights).
  • Law 44/2024/QH15 — amended Pharmacy Law; effective 1 July 2025.

Implementing decree:

  • Decree 163/2025/NĐ-CP — Chapter IV "Xuất khẩu, nhập khẩu thuốc, nguyên liệu làm thuốc". Replaces the NĐ 54/2017 + NĐ 88/2023 stack on import-export. Confirmed inner articles: Article 50 (export of special-control drugs), Articles 54–56 (special-import categories), Article 71 (15-day timeline for special-control drug imports), and the Articles 91–93 range (foreign-manufacturer / foreign-supplier register, GMP-status updates).

Circulars:

  • Circular 12/2025/TT-BYT — marketing-authorisation registration (the prerequisite for ordinary commercial drug import). Effective 1 July 2025.
  • Circular 28/2025/TT-BYT — Good Manufacturing Practice; replaces TT 35/2018/TT-BYT. Effective 1 July 2025.
  • Circular 11/2025/TT-BYT — cross-cutting amendment of GPP (TT 02/2018), GDP (TT 03/2018) and GSP (TT 36/2018). Relevant where the importer also operates as wholesaler or storage-service provider.

Customs:

  • Customs Law 54/2014/QH13 — effective 1 January 2015; the umbrella statute for customs clearance, including pharmaceutical shipments.

International:

  • 1961 Hague Convention Abolishing the Requirement of Legalisation for Foreign Public Documents (Apostille). Vietnam acceded 31 December 2025; in force from 11 September 2026. Replaces consular legalisation of CPPs and similar documents originating from Convention member states.

DAV operational procedure:

  • DAV procedure QT.ĐT.02.01 — issuance of the Certificate of Pharmaceutical Product (CPP) and the Free Sale Certificate (FSC) for Vietnamese-manufactured drugs to be exported.

Penalties:

  • Decree 117/2020/NĐ-CP — administrative penalties in the healthcare field; covers import-without-licence and counterfeit-drug administrative breaches. Amended by Decree 124/2021/NĐ-CP .
  • Decree 128/2020/NĐ-CP — administrative penalties in customs; covers customs-procedure breaches including forged documents.
  • Penal Code 2015 Article 194 — counterfeit medicines.

Source documents

Direct links to the official text on government portals.

Pharmacy Law and amendments:

Decree:

Circulars:

Customs:

International:

DAV operational portals:

Penalties:

Medibase cross-references:

  • Reference — Distribution & Retail — /medicine/distribution-retail/
  • Reference — Special-Control Medicines — /medicine/special-control/
  • Reference — Drug Registration Process — /medicine/registration/
  • Search — Foreign Drug Importers (DAV cn97 / cn98 lookup) — /search/foreign-drug-importers/

Recent updates

21 November 2024 — National Assembly passes Law 44/2024/QH15 amending the Pharmacy Law; adds Article 53a defining the rights of foreign-invested pharmaceutical enterprises.

16 May 2025 — Ministry of Health issues Circular 12/2025/TT-BYT on marketing-authorisation registration.

29 June 2025 — Government issues Decree 163/2025/NĐ-CP, consolidating import-export operational rules into Chapter IV.

1 July 2025 — Simultaneous effective date: amended Pharmacy Law (Law 44/2024), Decree 163/2025/NĐ-CP, Circular 12/2025/TT-BYT (registration), Circular 11/2025/TT-BYT (GPP/GDP/GSP) and Circular 28/2025/TT-BYT (GMP, replacing TT 35/2018).

31 December 2025 — Vietnam deposits its instrument of accession to the 1961 Hague Apostille Convention.

11 September 2026 — Apostille Convention enters into force for Vietnam. Apostilles issued by Convention member states replace consular legalisation for documents originating from those states; documents from non-member states continue to require consular legalisation.

Resources & links

Operational portals:

  • Drug Administration of Vietnam (DAV) — https://dav.gov.vn — main agency for drug import-export licensing; CPP / FSC issuance and the foreign-supplier register.
  • DAV public services portal — https://dichvucong.dav.gov.vn — online submission for import licences, MA renewal, special import dossiers.
  • Vietnam General Department of Customs — https://www.customs.gov.vn — customs procedure, HS-code lookup, and bonded warehouse rules.
  • Cục Lãnh sự (Consular Department, Ministry of Foreign Affairs) — https://lanhsuvietnam.gov.vn — consular legalisation procedure (through 10 September 2026); from 11 September 2026, designated apostille issuing authorities.

Legal text portals:

  • Cổng thông tin điện tử Chính phủ — văn bản pháp luật — https://vanban.chinhphu.vn — primary publisher of laws and decrees.
  • Công báo điện tử — https://congbao.chinhphu.vn — Official Gazette.
  • Thư viện pháp luật — https://thuvienphapluat.vn — searchable archive with selected English working translations.
  • Cổng pháp luật quốc gia (Bộ Tư pháp) — https://vbpl.vn — official national legal database.

International:

  • Hague Conference on Private International Law (HCCH) — https://www.hcch.net — official depository of the 1961 Apostille Convention; list of competent authorities by member state.
  • Vietnam permanent representation lookup for foreign embassies and consular legalisation — https://lanhsuvietnam.gov.vn.

Medibase cross-references:

  • Reference — Distribution & Retail — /medicine/distribution-retail/
  • Reference — Special-Control Medicines — /medicine/special-control/
  • Reference — Drug Registration Process — /medicine/registration/
  • Search — Foreign Drug Importers — /search/foreign-drug-importers/

Frequently asked questions

Có thể nhập khẩu thuốc chưa có giấy đăng ký lưu hành tại Việt Nam không?

Có, theo chế độ giấy phép nhập khẩu đặc biệt tại Chương IV Nghị định 163/2025/NĐ-CP. Các nhóm gồm: thuốc đáp ứng nhu cầu điều trị đặc biệt như nhu cầu cá nhân hoặc bệnh hiếm (Điều 54); thuốc có hoạt chất chưa được đăng ký tại Việt Nam (Điều 55); thuốc có hoạt chất đã đăng ký nhưng nguồn cung không đủ (Điều 56); thuốc cho nhu cầu khẩn cấp quốc phòng, an ninh, phòng chống dịch hoặc khắc phục thiên tai; và nhập khẩu phi thương mại như mẫu đăng ký, mẫu kiểm nghiệm, thử lâm sàng, nghiên cứu khoa học, viện trợ nhân đạo, và hành lý cá nhân trong giới hạn pháp luật. Mỗi nhóm có hồ sơ và thời hạn riêng. Thuốc kiểm soát đặc biệt theo Điều 71 với thời hạn 15 ngày.

Cơ quan nào cấp giấy phép nhập khẩu thuốc?

Cục Quản lý Dược (DAV) thuộc Bộ Y tế là cơ quan cấp trung ương đối với giấy phép nhập khẩu thương mại thường, giấy phép nhập khẩu đặc biệt, và CPP / FSC cho xuất khẩu. Sở Y tế cấp tỉnh cấp giấy phép nhập khẩu thuốc kiểm soát đặc biệt cho các dược chất thuộc phạm vi cấp tỉnh theo Điều 71 Nghị định 163/2025. Thông quan do Tổng cục Hải quan thực hiện, đối chiếu với giấy phép của DAV.

Điều 53a thay đổi gì cho doanh nghiệp dược có vốn nước ngoài?

Điều 53a, do Luật 44/2024/QH15 bổ sung vào Luật Dược (hiệu lực 01/7/2025), là định nghĩa luật định rõ ràng đầu tiên về quyền của doanh nghiệp dược có vốn nước ngoài. FIE được nhập khẩu thuốc, bán thuốc nhập khẩu cho cơ sở bán buôn Việt Nam được cấp phép và cho một số bệnh viện và cơ sở điều trị xác định, và bán thuốc do mình sản xuất, sản xuất theo hợp đồng hoặc nhận chuyển giao công nghệ tại Việt Nam. FIE không được thực hiện bảo quản hoặc vận chuyển bán buôn độc lập không liên quan đến hoạt động bán của mình, và không được tham gia bán lẻ trực tiếp. Nhà tài trợ nước ngoài thường vận hành chuỗi phân phối qua đối tác cơ sở bán buôn hoặc nhà phân phối Việt Nam.

Khi nào Apostille thay thế hợp pháp hóa lãnh sự cho CPP?

Từ 11/9/2026 — ngày Công ước Hague Apostille 1961 có hiệu lực tại Việt Nam sau văn kiện gia nhập ngày 31/12/2025. Apostille do cơ quan có thẩm quyền của một quốc gia thành viên Công ước cấp sẽ thay thế hợp pháp hóa lãnh sự đối với tài liệu xuất xứ từ quốc gia đó. Tài liệu từ quốc gia không phải thành viên tiếp tục yêu cầu hợp pháp hóa lãnh sự bởi cơ quan lãnh sự Việt Nam. Thông báo chuyển tiếp của Bộ Y tế hoặc DAV làm rõ thực thi cụ thể trong lĩnh vực dược dự kiến công bố trong năm 2026.

Chế tài khi nhập khẩu thuốc không có giấy phép là gì?

Ba lớp. Chế tài hành chính theo Nghị định 117/2020/NĐ-CP (lĩnh vực y tế, sửa đổi bởi Nghị định 124/2021/NĐ-CP) và Nghị định 128/2020/NĐ-CP (lĩnh vực hải quan) đi từ cảnh cáo và phạt tiền cố định đến đình chỉ GCN ĐĐKKDD và thu hồi CCHND của người chịu trách nhiệm. Trách nhiệm hình sự theo Bộ luật Hình sự 2015 Điều 194 — sản xuất, buôn bán hàng giả là thuốc chữa bệnh, thuốc phòng bệnh — chế tài 2–7 năm và đến chung thân hoặc tử hình trong các tình tiết tăng nặng. Giám sát quốc tế áp dụng cho dược chất kiểm soát đặc biệt (báo cáo INCB hằng năm theo Công ước 1961 và 1971).

Page changelog

2026-06-28: Initial publication. Reflects amended Pharmacy Law 44/2024/QH15 (new Article 53a on FIE rights), Decree 163/2025/NĐ-CP Chapter IV (consolidating import-export operational rules), Circular 12/2025/TT-BYT (registration), Circular 28/2025/TT-BYT (GMP), Customs Law 54/2014/QH13, and the 1961 Hague Apostille Convention (in force for Vietnam 11 September 2026).

Effective from:
2025-07-01
Last reviewed:
2026-06-28
Page updated:
2026-06-28

Reference information only; not legal or medical advice.