Tiếng Việt
中文 (中国)
Cosmetic–drug borderline / Treatment claim
IMPORT PROCEDURE FOR ACNE PRODUCTS WITH TREATMENT CLAIMS
Acne products with treatment claims are a high-risk borderline category between skincare cosmetics and topical medicinal products. A single wording such as “treats acne”, “heals acne”, “stops acne” or the presence of medicinal active ingredients may change the HS code, duty exposure, specialized import dossier, labelling route and market circulation requirements. This article provides an E2E (End-to-End) control map before ETA: product classification, HS Code, tax, C/O, marketing authorization or import permit, customs documents, labelling and pre-arrival risk controls.
QUICK FACT TABLE
| Item | What must be fixed | Files/checkpoints | Risk if wrong |
|---|---|---|---|
| Product scope | Acne product with treatment claim: cream, gel, lotion, solution, spot treatment or patch with therapeutic acne wording. | Catalogue, label, leaflet, marketing claim, active ingredients, retail packing. | Misclassified as cosmetic, missing drug-related import dossier or wrong HS. |
| Classification driver | Claims such as treats, heals, prevents or stops acne may move the product outside cosmetics. | Label, website, brochure, usage direction and manufacturer documents. | Customs/regulatory explanation, delay or rejection. |
| HS direction | Review heading 3004 if the product is for therapeutic/prophylactic use and packed for retail; do not automatically use 3304. | Active ingredients, dosage form, main use, retail packing, indication. | Wrong duty, wrong specialized policy and wrong import dossier. |
| Specialized policy | May be governed as a drug and require MA/import permit depending on actual dossier. | MA/import permit, CPP/CFS, GMP, COA, label/leaflet, importer qualification. | Cargo hold, no legal circulation or post-clearance risk. |
Legal note: This article deals with products retaining treatment claims. ASEAN cosmetic claim guidance gives examples of unacceptable skin cosmetic claims such as prevents, heals, treats or stops acne. Anti-acne may only be considered a cosmetic claim in limited cases when it is secondary and the product otherwise meets cosmetic criteria.
SCOPE OF APPLICATION
This article applies only to acne products with therapeutic treatment wording. It does not automatically apply to ordinary anti-acne cosmetics without treatment claims, antibacterial/disinfecting products, beauty supplements, beauty devices, research samples or EPE/FDI project shipments. The actual catalogue, formula, label, claim, SKU and import purpose must be reviewed before shipment.
PRODUCT CLASSIFICATION AND TECHNICAL IDENTIFICATION
| Checkpoint | Documents to compare | Risk if misdescribed | Suggested goods description |
|---|---|---|---|
| Claim and intended use | Label, leaflet, catalogue, website and advertisements. | Cosmetic filing may be rejected or drug dossier requested. | Describe as topical acne treatment cream/gel/solution/patch if the drug route is confirmed. |
| Active ingredients | Formula, COA, SDS/MSDS and specifications. | Antibiotic/retinoid/medicinal active ingredient may be missed. | Mention dosage form and key active ingredient where legally appropriate. |
| Dosage form and packing | Product photos, retail box, tube/bottle/patch specifications. | Cream, gel and medicated patch may fall under different HS directions. | State cream/gel/solution/patch, net weight/volume and retail packing. |
| Import purpose | Contract, PO, R&D plan and regulatory files. | Commercial goods may be wrongly declared as samples or cosmetics. | Clarify commercial import, R&D, testing or internal use. |
HS CODE – DUTY – C/O
HS classification must follow the product substance, not the commercial name. If the product is presented for treatment or prophylaxis and packed for retail sale, heading 3004 is the main review direction. Heading 3304 should only be considered if the product is genuinely a cosmetic and the treatment claim is removed or legally adjusted.
| Indicative HS code | Application condition | Indicative import duty | VAT/checkpoint | Risk | Files to review |
|---|---|---|---|---|---|
| 3004.90.99 – Other medicaments | Topical treatment product packed for retail and not covered by a more specific drug line. | MFN 0%; ordinary duty generally 0% if calculated from 0% MFN; C/O may have limited duty impact. | If the product is determined to be a preventive/curative medicine, VAT must be reviewed under current VAT law; medicines are commonly reviewed under the 5% bracket. Do not automatically use the 10% cosmetic VAT treatment for a product classified as a drug. | Using cosmetic HS while retaining treatment claims may cause regulatory mismatch. | Formula, active ingredients, leaflet, label, MA/import permit, invoice and packing list. |
| 3004.20.xx – Medicaments containing antibiotics | Where the formula contains antibiotics for acne treatment; final 8-digit code depends on active ingredient and form. | Some Trade Portal lines show MFN 5%; ordinary duty may be 7.5%; FTA must be checked by final HS. | If classified as antibiotic-containing medicine for prevention/treatment, review VAT under the medicine bracket, commonly 5%. If the dossier does not support drug status, VAT must be re-confirmed by the actual HS. | Missing antibiotic classification may lead to wrong HS and import condition. | Formula, COA, SDS, leaflet, label and drug dossier. |
| 3005 – Medicated dressings/patches | Only if the product is a medicated patch, dressing or similar article. | By final 8-digit HS. | By final HS and tax status. | Treating a medicated patch as a cream/gel can be wrong. | Material structure, medicated layer, backing film and intended use. |
| 3304.99.20 – Anti-acne preparations | Only if the product is a lawful cosmetic and the claim is limited to cosmetic prevention/support, without treatment, healing or stopping acne. | Indicative MFN 20%; ordinary duty 30%; special preferential duty depends on valid C/O/FTA. | Cosmetics are commonly reviewed at VAT 10% or under the applicable VAT policy of the period. | Using 3304.99.20 while keeping drug-like treatment claims may trigger rejection, drug-policy review or post-clearance claim risk. | Cosmetic notification, PIF, formula, label, claim substantiation and proof that the product is not a drug. |
| 3304.99.90 – Other skincare/cosmetic preparations | Only if the product is another cosmetic skincare preparation and 3304.99.20 does not fit. | Indicative MFN 20%; ordinary duty 30%; special preferential duty depends on valid C/O. | Usually 10% or the VAT policy applicable at import. | Wrongly classifying anti-acne or drug-like products under 3304.99.90 may distort both HS and policy. | Catalogue, label, formula, claims, cosmetic notification/PIF if cosmetic. |
C/O and FTA review
| Origin route | C/O or origin document | Preferential duty review | Key conditions | Documents | Risk |
|---|---|---|---|---|---|
| ASEAN | Form D / ATIGA document | For HS 3004.90.99 Trade Portal shows ATIGA 0%; other codes must be checked. | Origin rule and direct transport. | C/O, invoice, packing list, B/L and origin criterion. | Wrong form or HS discrepancy. |
| China | Form E or RCEP | Check ACFTA/RCEP by final HS. | Correct origin rule, third-party invoice and transit documents. | C/O, invoice, through B/L, goods description. | Common risk: Form E description/HS/third-party invoice mismatch. |
| Korea/Japan/EU/UK/Oceania/India/Hong Kong | Relevant FTA C/O or origin statement | Compare all applicable FTAs by final HS. | Valid origin proof and transport route. | C/O/origin statement, invoice, packing list and transport documents. | Preferential duty rejected due to non-matching data. |
SPECIALIZED POLICY MATRIX
| Goods scenario | Possible policy | Files to check | Authority/portal | Timing | Risk note |
|---|---|---|---|---|---|
| Cosmetic with only secondary anti-acne claim | Cosmetic notification if cosmetic definition and ASEAN claim rules are met. | Notification, PIF, formula, label and claim. | Drug Administration/SOH as applicable. | Before commercial import. | Not applicable if treatment claim is retained. |
| Treatment acne claim | Likely outside cosmetics; drug route must be reviewed. | MA/import permit, CPP/CFS, GMP, COA, label and leaflet. | Drug Administration of Vietnam / Ministry of Health. | Before PO and before ETA. | Do not import as ordinary cosmetic before classification is closed. |
| Medicinal active ingredients | Drug import conditions and importer qualification may apply. | Active list, dosage form, quality dossier, storage conditions. | Ministry of Health. | Before shipment. | Cargo may be held without proper drug dossier. |
| Research/testing samples | Specific sample route depending on purpose and quantity. | Sample order, use plan, technical documents and non-circulation commitment. | Relevant specialized authority. | Before ETA. | Do not disguise commercial goods as samples. |
LEGAL DOCUMENTS TO REVIEW
| Document group | Name/number | Issuer | Effective timing | Role | Key point | Review note |
|---|---|---|---|---|---|---|
| Cosmetics circular | Circular 06/2011/TT-BYT | Ministry of Health | Effective from 01/04/2011; amended; check current status. | Cosmetic definition, notification, PIF and claim review. | Article 2, Article 3 and Appendix 03-MP. | Treatment acne claim is a high-risk borderline point. |
| ASEAN claim guidance | ASEAN Cosmetic Claims Guidelines / Appendix III | ASEAN / referenced by cosmetic regulations | Used for cosmetic claim assessment. | Distinguishes acceptable and unacceptable cosmetic claims. | Unacceptable examples include prevents, heals, treats or stops acne. | Final decision depends on competent authority. |
| Pharmacy law | Law on Pharmacy 105/2016/QH13 | National Assembly | Effective from 01/01/2017. | Framework for drugs, drug business and import. | MA/import permit and drug business conditions. | Applies if product is determined as a drug. |
| Pharmacy decree | Decree 163/2025/ND-CP | Government | Issued 29/06/2025, effective 01/07/2025. | Detailed rules for implementing the Pharmacy Law including import/export. | Drug import/export and permit validity. | Use the current decree, not only older rules. |
| VAT | VAT Law 48/2024/QH15 and Decree 181/2025/ND-CP | National Assembly/Government | Effective from 01/07/2025; period-specific VAT reduction policy should be checked. | Determines VAT by actual product nature: medicine, cosmetic or other goods. | VAT brackets and detailed guidance/appendices if applicable. | Do not rely on a single tariff lookup VAT figure when the product is on the drug–cosmetic borderline. |
| Labelling | Decree 43/2017/ND-CP and Decree 111/2021/ND-CP | Government | Check current effect. | Original and Vietnamese supplementary labels. | Mandatory labelling content. | Drug labels and cosmetic labels are not interchangeable. |
VIEW / DOWNLOAD ORIGINAL LEGAL DOCUMENTS
Businesses should verify the relevant documents on official legal databases or competent authority websites before application.
CUSTOMS DOCUMENT DOSSIER
| File group | Required documents | Used for | Usually prepared by | Common error | Pre-ETA check |
|---|---|---|---|---|---|
| Chứng từ thương mại | Commercial Invoice, Packing List, Sales Contract/Purchase Order. | Khóa bộ chứng từ, khai trị giá, mở tờ khai. | Importer, procurement, shipper, sales logistics. | Tên hàng ghi “acne cream” quá chung; không thể hiện dạng bào chế/hoạt chất. | Đối chiếu tên hàng, quy cách, số lượng, trị giá, điều kiện Incoterms. |
| Vận tải | B/L hoặc AWB, Arrival Notice, Pre-alert. | Theo dõi ETA, lấy D/O, kiểm soát DEM/DET. | Forwarder, đại lý, shipper. | Chứng từ vận tải về muộn hoặc sai consignee/notify. | Yêu cầu pre-alert trước ETA, rà soát consignee, số kiện, gross weight. |
| Kỹ thuật sản phẩm | Catalogue, leaflet, nhãn gốc, ảnh sản phẩm, công thức/active list, COA, SDS/MSDS nếu có. | Phân loại HS, chính sách chuyên ngành, giải trình hải quan. | Nhà sản xuất, supplier, legal/compliance. | Claim điều trị nằm trong brochure/website nhưng không nằm trên invoice. | Rà soát toàn bộ tài liệu bán hàng, không chỉ nhãn. |
| Hồ sơ dược nếu là thuốc | Số đăng ký lưu hành hoặc giấy phép nhập khẩu thuốc, CPP/CFS, GMP, giấy ủy quyền, hồ sơ cơ sở nhập khẩu. | Chốt điều kiện nhập khẩu chuyên ngành. | Importer, regulatory affairs, legal. | Có claim thuốc nhưng không có hồ sơ dược tương ứng. | Xác nhận trạng thái lưu hành/giấy phép trước khi đặt hàng. |
| C/O và thuế | C/O, statement on origin nếu có, hóa đơn bên thứ ba, chứng từ vận chuyển trực tiếp. | Áp ưu đãi đặc biệt, khai xuất xứ. | Supplier, shipper, procurement, customs broker. | C/O sai mô tả, sai HS, sai form, phát hành sau không đúng. | So khớp C/O với invoice, packing list, tờ khai và HS chính thức. |
| Nhãn | Nhãn gốc, nhãn phụ dự kiến, leaflet, cảnh báo, số đăng ký/giấy phép nếu áp dụng. | Thông quan/lưu thông/hậu kiểm. | Importer, marketing, compliance. | Nhãn vẫn ghi mỹ phẩm trong khi claim/hoạt chất là thuốc. | Kiểm nhãn theo đường pháp lý đã chốt: mỹ phẩm hoặc thuốc. |
CLEARANCE DECISION POINTS
| Decision point | Question | Evidence | Consequence | Recommended action |
|---|---|---|---|---|
| Claim điều trị | Sản phẩm có tuyên bố trị/chữa/ngăn ngừa/điều trị mụn không? | Nhãn, leaflet, website, brochure, video quảng cáo. | Bị bác theo mỹ phẩm hoặc yêu cầu hồ sơ dược. | Khóa claim trước khi nhập; nếu giữ claim điều trị thì đi theo hướng dược. |
| Hoạt chất | Có kháng sinh, retinoid hoặc hoạt chất điều trị không? | Formula, COA, MSDS, specification. | Sai HS và sai điều kiện chuyên ngành. | Rà soát hoạt chất với regulatory trước khi ký hợp đồng. |
| HS Code | Có đủ căn cứ áp 3004/3005 hay vẫn là 3304? | Catalogue, thành phần, công dụng chính, dạng bào chế. | Sai thuế, sai giấy phép, dễ chuyển luồng. | Lập bảng phân loại HS theo từng SKU. |
| Điều kiện nhập khẩu | Có số đăng ký lưu hành/giấy phép nhập khẩu thuốc chưa? | MA/import permit, CPP/CFS, authorization, GMP. | Không đủ điều kiện thông quan/lưu thông. | Xin/kiểm tra hồ sơ chuyên ngành trước ETA. |
| C/O | C/O có đúng form, tiêu chí và mô tả không? | C/O, invoice, B/L, packing list. | Không được hưởng ưu đãi hoặc bị bác C/O. | Rà soát C/O bản nháp trước khi phát hành. |
| Nhãn | Nhãn thuốc/mỹ phẩm có thống nhất với đường pháp lý không? | Nhãn gốc, nhãn phụ, leaflet. | Rủi ro hậu kiểm, thu hồi hoặc xử phạt nhãn. | Chỉ in/duyệt nhãn sau khi chốt phân loại. |
PRACTICAL E2E PROCEDURE
Step 1: Pre-ETA review
Close claim, formula, HS, tax, C/O, label and specialized import conditions.
Step 2: Lock documents
Check invoice, packing list, B/L/AWB, catalogue, leaflet, label, active ingredient and origin.
Step 3: Specialized dossier
If treated as a drug, verify MA/import permit and importer qualification before arrival.
Step 4: Customs declaration
Green channel may be cleared by system; Yellow checks documents; Red checks documents and physical goods.
Step 5: Clearance and post-clearance file
Pay duties, release cargo, control labels, and retain dossier for post-clearance explanation.
Step 6: Market circulation control
Release products only through the legal route already confirmed: cosmetic or drug.
PRE-ETA RISK CHECKLIST
| Risk | Consequence | Pre-ETA control | Documents to check |
|---|---|---|---|
| Giữ claim “trị mụn/điều trị mụn” nhưng làm hồ sơ mỹ phẩm | Bị yêu cầu giải trình, chuyển hướng hồ sơ, chậm thông quan hoặc không được lưu thông. | Chốt đường pháp lý trước khi đặt hàng: mỹ phẩm claim phụ hay thuốc điều trị. | Nhãn, claim, công thức, hồ sơ công bố/giấy phép. |
| Áp HS 3304 cho sản phẩm có bản chất thuốc | Sai thuế và sai chính sách chuyên ngành. | Rà soát theo công dụng chính, hoạt chất và dạng bào chế. | Catalogue, formula, COA, leaflet, Trade Portal. |
| Không có giấy phép/số đăng ký lưu hành thuốc | Không đủ căn cứ nhập khẩu/lưu thông. | Kiểm tra hồ sơ dược và điều kiện cơ sở nhập khẩu trước khi hàng đi. | MA/import permit, GDP/GSP nếu liên quan, CPP/CFS, GMP. |
| C/O sai form hoặc sai mô tả hàng | Không được hưởng ưu đãi, có thể bị yêu cầu bổ sung/xác minh. | Rà C/O draft theo HS, tên hàng, số lượng, invoice và vận tải trực tiếp. | C/O, invoice, packing list, B/L. |
| Nhãn phụ không thống nhất với hồ sơ pháp lý | Risk hậu kiểm, xử phạt nhãn, không được lưu thông. | Duyệt nhãn sau khi chốt phân loại pháp lý và claim. | Nhãn gốc, nhãn phụ, leaflet, số đăng ký/phiếu công bố nếu có. |
| Mô tả hàng quá chung chung | Bị hỏi thêm catalogue, hoạt chất, mục đích sử dụng; kéo dài thông quan. | Ghi tên hàng đầy đủ: dạng sản phẩm, công dụng, hoạt chất chính nếu phù hợp, quy cách. | Invoice, packing list, catalogue, tờ khai. |
FAQ
| Question | Answer |
|---|---|
| Can an acne treatment claim product be notified as a cosmetic? | Do not assume so. Treatment/healing/prevention claims may move the product outside cosmetics. |
| Is every anti-acne product a drug? | No. Anti-acne may be secondary cosmetic claim only if the product and claims remain within cosmetic scope. |
| Which HS code is commonly reviewed? | Heading 3004 is the main direction for retail therapeutic products; final HS depends on formula and dosage form. |
| Is an import permit required? | Possibly, if the product is determined as a drug or falls under drug import permit scenarios. |
| Can C/O reduce duty? | Possibly, but where MFN is already 0%, C/O may have limited duty impact. |
| Should the Vietnamese label follow cosmetic or drug rules? | It must follow the legal classification already confirmed. |
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IMPLEMENTATION SUPPORT FROM TGIMEX
This article provides a control map for HS, tax, C/O, specialized dossier and labelling. In actual shipments, all documents must be reviewed against catalogue, formula, claim, label, legal status, origin and import purpose.
- Pre-ETA review: HS, policy, C/O, tax, label and claim dossier.
- Compliance control: invoice, packing list, B/L/AWB, C/O, permit, MA and technical files.
- International logistics coordination: agents, carriers, ETA, pre-alert and transport documents.
- Customs declaration and channel handling.
- Post-clearance file retention and explanation support.
For cargo that may involve specialized inspection, import permits, C/O or labelling requirements, businesses should not wait until arrival to start dossier review.
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