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.

Illustration for Import procedure for acne products with treatment claims — Illustration of the product group and document review before customs clearance.

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.

Circular 06/2011/TT-BYT ASEAN Claims Guideline Decree 163/2025/ND-CP Law on Pharmacy

CUSTOMS DOCUMENT DOSSIER

File group	Required documents	Used for	Usually prepared by	Common error	Pre-ETA check
Commercial documents	Commercial Invoice, Packing List, Sales Contract/Purchase Order.	Lock the set of documents, declare the value, open the declaration.	Importer, procurement, shipper, sales logistics.	The product name says “acne cream” which is too general; Dosage form/active ingredient not shown.	Compare product names, specifications, quantities, values, and conditions Incoterms.
Transport	B/L hoặc AWB, Arrival Notice, Pre-alert.	Track ETA, get D/O, control DEM/DET.	Forwarder, đại lý, shipper.	Transport documents are late or wrong consignee/notify.	Request pre-alert before ETA, check consignee, number of packages, gross weight.
Kỹ thuật sản phẩm	Catalog, leaflet, original label, product photo, formula/active list, COA, SDS/MSDS if any.	HS classification, specialized policies, customs explanations.	Nhà sản xuất, supplier, legal/compliance.	Treatment claim is in the brochure/website but not on the invoice.	Review all sales materials, not just labels.
Pharmaceutical records if drugs	Circulation registration number or drug import license, CPP/CFS, GMP, authorization letter, import facility records.	Closing specialized import conditions.	Importer, regulatory affairs, legal.	There is a drug claim but no corresponding pharmacy records.	Confirm circulation/licensing status before ordering.
C/O và thuế	C/O, statement on origin if available, third party invoice, direct shipping documents.	Apply special incentives, declare origin.	Supplier, shipper, procurement, customs broker.	C/O has wrong description, wrong HS, wrong form, incorrectly issued later.	Match C/O with invoice, packing list, declaration and official documents.
Nhãn	Original label, proposed secondary label, leaflet, warning, registration/license number if applicable.	Customs clearance/circulation/post-inspection.	Importer, marketing, compliance.	The label still says cosmetics while the claim/active ingredient is medicine.	Check the label according to the established legal path: cosmetic or medicine.

CLEARANCE DECISION POINTS

Decision point	Question	Evidence	Consequence	Recommended action
Claim điều trị	Does the product claim to cure/cure/prevent/treat acne?	Nhãn, leaflet, website, brochure, video quảng cáo.	Rejected according to cosmetics or pharmaceutical records request.	Lock claims before importing; If you keep claiming treatment, then go in the direction of medicine.
Hoạt chất	Are there antibiotics, retinoids or active treatment ingredients?	Formula, COA, MSDS, specification.	Wrong students and wrong specialized conditions.	Review active ingredients with regulatory before signing a contract.
HS Code	Are there enough grounds to apply 3004/3005 or is it still 3304?	Catalog, ingredients, main uses, dosage form.	Sai thuế, sai giấy phép, dễ chuyển luồng.	Create a table to classify students according to each SKU.
Import conditions	Do you have a circulation registration number/drug import license?	MA/import permit, CPP/CFS, authorization, GMP.	Not eligible for customs clearance/circulation.	Apply/check specialized documents before ETA.
C/O	Does the C/O have the correct form, criteria and description?	C/O, invoice, B/L, packing list.	Not eligible for incentives or C/O rejected.	Review draft C/O before issuance.
Nhãn	Is the medicine/cosmetic label consistent with the legal line?	Original label, secondary label, leaflet.	Risk of post-inspection, recall or label sanctions.	Only print/approve labels after finalizing classification.

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
Keep the claim “acne treatment/acne treatment” but make cosmetic records	Being asked to explain, redirecting documents, delaying customs clearance or not being allowed to circulate.	Check the legal route before ordering: cosmetics claiming side effects or medical treatment.	Label, claim, formula, publication/license records.
HS 3304 applies to products of medicinal nature	Wrong taxes and wrong specialized policies.	Review by main uses, active ingredients and dosage form.	Catalogue, formula, COA, leaflet, Trade Portal.
There is no license/registration number for drug circulation	Insufficient basis for import/circulation.	Check pharmaceutical records and import facility conditions before goods leave.	MA/import permit, GDP/GSP if relevant, CPP/CFS, GMP.
C/O in wrong form or wrong description of goods	Not eligible for incentives, additional/verification may be required.	Review C/O draft according to HS, product name, quantity, invoice and direct transportation.	C/O, invoice, packing list, B/L.
Secondary labels are inconsistent with legal documents	Risk post-inspection, penalty label, not allowed to circulate.	Browse the label after finalizing the legal classification and claim.	Original label, secondary label, leaflet, registration number/announcement form if any.
Product description is too general	Asked for additional catalogs, active ingredients, and intended uses; prolong customs clearance.	Write full product name: product form, uses, main active ingredients if appropriate, and specifications.	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.

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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