Templates & Checklists
Curated links to the major application forms, registration dossiers, GxP audit checklists, and licensing templates used across Vietnamese healthcare regulation. Medibase does not re-host the templates — each entry points to the authoritative source on the relevant agency portal (DAV, IMDA, MOH, etc.).
25 templates
Medicine
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ASEAN Common Technical Dossier (ACTD)
ASEAN ACTD — Common Technical Dossier for Drug Registration
The ASEAN Common Technical Dossier (ACTD) is the regional dossier format used across ASEAN member states for drug regis…
Authority: Drug Administration of Vietnam (DAV), MOH -
ADR / AEFI report form
ADR / AEFI Report Form (Trung tâm DI & ADR Quốc gia)
Adverse drug reaction (ADR) and adverse event following immunisation (AEFI) report forms submitted to the Trung tâm DI …
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CCHND — pharmacy practice certificate application
CCHND Application — Pharmacy Practice Certificate
Application dossier for the Chứng chỉ hành nghề dược (CCHND) — the pharmacy-practice certificate required for every res…
Authority: Sở Y tế -
Clinical trial / BE application
Clinical Trial Application (TT 50/2025/TT-BYT)
Two-stage application: trial-registration dossier (Form 6 + IB summary) and study-approval dossier (full IB, protocol w…
Authority: Cục Khoa học công nghệ và Đào tạo (ASTT) -
CPP / FSC export certificate application
CPP / FSC — Export Certificate Application (DAV QT.ĐT.02.01)
Application for the Certificate of Pharmaceutical Product (CPP) and Free Sale Certificate (FSC) issued by DAV for Vietn…
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GACP cultivation / collection checklist
GACP — Cultivation and Collection of Medicinal Plants Checklist
GACP audit checklist under Circular 19/2019/TT-BYT, aligned with WHO GACP. Three-year certificate validity. Mandatory f…
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GCN ĐĐKKDD — pharmacy business eligibility certificate
GCN ĐĐKKDD Application — Pharmacy Business Eligibility
Application dossier for the Giấy chứng nhận đủ điều kiện kinh doanh dược (GCN ĐĐKKDD) — the umbrella business-condition…
Authority: DAV (central) or Sở Y tế (retail) -
GDP audit / inspection checklist
GDP — Good Distribution Practice Audit Checklist
Audit checklist for Good Distribution Practice at wholesale establishments. Inspections conducted by DAV inspectors dur…
Authority: Drug Administration of Vietnam (DAV) -
GMP audit / inspection checklist
GMP — Good Manufacturing Practice Audit Checklist
Audit checklist for Good Manufacturing Practice, applied to drug manufacturers. Vietnam adopts WHO-GMP, EU-GMP and PIC/…
Authority: Drug Administration of Vietnam (DAV) -
GPP audit / inspection checklist
GPP — Good Pharmacy Practice Audit Checklist
The audit checklist used by Sở Y tế inspectors for Good Pharmacy Practice compliance at retail pharmacies, drug shops, …
Authority: Sở Y tế / DAV -
GSP audit / inspection checklist
GSP — Good Storage Practice Audit Checklist
Audit checklist for Good Storage Practice. Applies to manufacturers, wholesalers, importers, drug-storage service provi…
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Vaccine / biological lot release (NICVB)
Vaccine and Biological Lot Release Application (NICVB)
NICVB lot-release application required for every vaccine and biological batch — domestic and imported — before commerci…
Authority: National Institute for Control of Vaccines and Biologicals (NICVB) -
Special-import permit (drugs without registration)
Drug Special-Import Permit Application (Articles 54–56)
Application dossier for the special-import permit for drugs without a Vietnamese marketing authorisation — covering dru…
Authority: Drug Administration of Vietnam (DAV) -
Traditional medicine / dược liệu registration
Traditional Medicine, Vị Thuốc Cổ Truyền & Dược Liệu Registration
Marketing-authorisation registration for thuốc cổ truyền, vị thuốc cổ truyền and dược liệu under Circular 29/2025/TT-BY…
Authority: Cục Quản lý Y, Dược cổ truyền (MOH) -
Vaccine / biological registration
Vaccine and Biological Product Registration Dossier
The vaccine-and-biological registration dossier under Circular 12/2025/TT-BYT. Includes the modular CMC quality data, n…
Authority: DAV (registration); NICVB (lot release)
Supplement
Food
Medical device
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CPP / FSC export certificate application
Vietnamese CFS — Medical Device Export Application (IMDA)
Application for the Vietnamese Certificate of Free Sale (CFS) issued by IMDA for Class C/D medical devices manufactured…
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ASEAN Common Submission Dossier Template (CSDT)
ASEAN CSDT — Common Submission Dossier Template (Medical Devices)
The ASEAN Common Submission Dossier Template (CSDT) is mandatory for Class C and Class D medical-device registration do…
Authority: IMDA (Cục Hạ tầng và Thiết bị y tế), MOH -
Medical device registration / số lưu hành
Class A/B Medical Device Self-Declaration of Conformity
Self-declaration of conformity for Class A and Class B medical devices, filed with the provincial Sở Y tế of the regist…
Authority: Sở Y tế (provincial Department of Health)
Cosmetic
Practice
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CCHN KCB — medical practice certificate application
CCHN KCB Application — Medical Practice Certificate
Application dossier for the Chứng chỉ hành nghề khám bệnh, chữa bệnh (CCHN KCB) under Law 15/2023/QH15 and Decree 96/20…
Authority: Bộ Y tế (Cục Quản lý KCB) or Sở Y tế -
GPHĐ KCB — healthcare facility operating licence
GPHĐ KCB Application — Healthcare Facility Operating Licence
Application dossier for the Giấy phép hoạt động khám bệnh, chữa bệnh (GPHĐ KCB) — establishment-level operating licence…
Authority: Bộ Y tế or Sở Y tế cấp tỉnh -
Telemedicine service notification
Telemedicine Service Notification (Decree 96/2023 Article 87)
Light-touch notification — not a separate licence — required of facilities delivering telemedicine under Decree 96/2023…
Authority: Bộ Y tế (Cục Quản lý KCB) or Sở Y tế
General
Reference information only; not legal or medical advice. Medibase does not host the templates themselves and points to each agency portal — URLs accurate at publication.