Circular 41/2023/TT-BTC directly affects fee budgeting for drug marketing registration, import permits, cosmetic product notification, cosmetic CFS and the appraisal of manufacturing, practice and business conditions in pharmaceuticals and cosmetics.

QUICK SUMMARY

Effective date

01 Aug 2023

Core fees

Appraisal fees for marketing authorization, import permits, confirmation, product notification and business/practice conditions.

Operational point

Impacts state fee budgeting, professional dossier preparation and compliance records before products enter the Vietnamese market.

Legal note: This English version is for operational reference only and is not an official legal translation.

DOCUMENT INFORMATION

Field	Details
Document title	Circular on rates, collection, payment, management and use of fees in pharmaceuticals and cosmetics
Number	41/2023/TT-BTC
Issuing authority	Ministry of Finance
Issue date	12 June 2023
Effective date	01 August 2023
Validity status	To be checked at the time of filing. The National Legal Database records a partial expiry status, therefore later amendments must be reviewed.
Scope	Fee rates and rules on collection, payment, management and use of fees in pharmaceuticals and cosmetics.

KEY POINTS TO NOTE

Article 1 covers two main groups: appraisal fees for licensing/registration/import/confirmation/notification, and appraisal fees for standards, practice conditions and business conditions in pharmaceuticals and cosmetics.

The fee payer is the organization or individual submitting a dossier. Fee collectors include the Ministry of Health, assigned units under the Ministry of Health and provincial Departments of Health depending on the specific administrative task.

No.	Fee item	Unit	Fee
I	Appraisal fees for marketing authorization, import licensing, confirmation and declaration in pharmaceuticals and cosmetics
1	Appraisal for confirmation of information/advertising content for drugs and cosmetics	Dossier	VND 1,600,000
2a	Appraisal for drug marketing registration certificates, excluding traditional medicinal ingredients	Dossier	VND 11,000,000
2b	Appraisal for marketing registration of drug ingredients and traditional medicinal ingredients	Dossier	VND 5,500,000
2c	Appraisal for renewal of marketing registration for drugs, drug ingredients and traditional medicinal ingredients	Dossier	VND 4,500,000
2d	Appraisal for variation/supplementation of marketing registration	Dossier	VND 1,500,000
3	Appraisal for import permits for drugs without marketing authorization in Vietnam, excluding certain cases under Decree 54/2017/ND-CP	Item	VND 1,200,000
4	Appraisal for cosmetic product notification and declaration of standards/quality for medicinal materials	Dossier	VND 500,000
II	Appraisal fees for standards, practice conditions and business conditions in pharmaceuticals and cosmetics
1	Appraisal for cosmetic production conditions and CGMP-ASEAN certificate	Facility	VND 30,000,000
2	Appraisal and assessment of GMP compliance for drugs, ingredients, medicinal materials and traditional medicinal ingredients	Facility	VND 30,000,000
3	Appraisal and assessment of good manufacturing practice for pharmaceutical packaging	Facility	VND 30,000,000
4	Appraisal and assessment of GSP compliance	Facility	VND 21,000,000
5	Appraisal and assessment of GLP compliance	Facility	VND 21,000,000
6	Appraisal and assessment of GDP compliance for wholesale drug establishments	Facility	VND 4,000,000
7	Appraisal for issuing/reissuing/amending pharmacy practice certificates	Dossier	VND 500,000
8a	GPP appraisal in difficult and especially difficult socio-economic areas	Facility	VND 500,000
8b	GPP appraisal in other areas	Facility	VND 1,000,000
9	Appraisal for drug price declaration/re-declaration	Dossier	VND 800,000
10	Appraisal of cosmetic manufacturing conditions for a cosmetic manufacturing eligibility certificate	Facility	VND 6,000,000
11a	Appraisal of retail establishments specializing in medicinal materials/traditional medicines in difficult areas	Facility	VND 300,000
11b	Appraisal of such establishments in other areas	Facility	VND 750,000
12	Assessment of GACP compliance for cultivation, harvesting and natural exploitation of medicinal materials	Dossier	VND 9,000,000
13a	Dossier appraisal for foreign GMP compliance in Vietnam marketing registration	Dossier	VND 2,250,000
13b	On-site appraisal/assessment at the foreign GMP facility, excluding travel and mission expenses	Facility	VND 200,000
14	Appraisal for Cosmetic Free Sale Certificate (CFS)	Item	VND 500,000
15	Appraisal and assessment of bioequivalence testing establishments	Facility	VND 21,000,000
16	Dossier appraisal for first and maintenance assessment of Good Clinical Practice for clinical trials	Dossier	VND 30,000,000

AFFECTED ENTERPRISES / PRODUCT GROUPS

Importers and registrants of drugs, drug ingredients, medicinal materials and cosmetics.
Brand owners, distributors and trading companies preparing product notification, CFS, advertising confirmation or import permit dossiers.
Manufacturers and business establishments subject to GMP, GSP, GLP, GDP, GPP, CGMP-ASEAN or similar appraisal.

IMPACT ON IMPORT-EXPORT / LOGISTICS OPERATIONS

Cost planning: the fee must be budgeted per dossier, item or facility, separately from freight, customs duty and testing fees.
Timeline: delayed fee payment or incomplete supporting documents may delay dossier appraisal.
Customs dossier: the fee does not change HS classification or import duty, but it supports the professional licensing/product compliance file.
Record retention: fee payment evidence, dossier receipts and appraisal results should be archived with the shipment/product compliance file.

ENTERPRISE CHECKLIST

Checklist item	Operational purpose	Status
Classify the product as drug, drug ingredient, cosmetic or medicinal material	Identify the right procedure and fee item	□
Confirm whether the dossier is for marketing registration, import permit, notification, CFS or advertising confirmation	Avoid applying the wrong fee unit	□
Identify the receiving authority	Ministry of Health, assigned unit or provincial Department of Health	□
Prepare product documents	CFS, LOA, GMP/CGMP, COA, formulation, label and supporting documents	□
Archive payment and appraisal documents	Needed for accounting, compliance and inspection	□

Group	Documents	Role
Laws	Law on Fees and Charges 2015; State Budget Law 2015; Law on Pharmacy 2016; Law on Tax Administration 2019	Legal basis for fee collection and management.
Decrees	Decree 120/2016/ND-CP; Decree 54/2017/ND-CP; Decree 126/2020/ND-CP; Decree 91/2022/ND-CP; Decree 14/2023/ND-CP	Detailed rules on fees, pharmacy, tax administration and the Ministry of Finance functions.
Replaced documents	Circular 277/2016/TT-BTC and Circular 114/2017/TT-BTC	Previous fee schedules replaced by Circular 41.

VIEW / DOWNLOAD ORIGINAL DOCUMENT

Government document page Open signed PDF Official Gazette

FULL TEXT OF THE LEGAL DOCUMENT

The document is short and contains a fee schedule. For stable WordPress display, the full text is reproduced as a white legal-text block instead of a small PDF frame. This English version is for operational reference only and is not an official legal translation.

OPEN FULL TEXT OF CIRCULAR 41/2023/TT-BTC

MINISTRY OF FINANCE
No. 41/2023/TT-BTC

SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
Hanoi, 12 June 2023

CIRCULAR
Providing fee rates, collection, payment, management and use of fees in the pharmaceutical and cosmetic sectors

Pursuant to the Law on Fees and Charges dated 25 November 2015; the Law on State Budget dated 25 June 2015; the Law on Pharmacy dated 06 April 2016; and the Law on Tax Administration dated 13 June 2019.

Pursuant to Decree No. 120/2016/ND-CP guiding the Law on Fees and Charges; Decree No. 54/2017/ND-CP guiding the Law on Pharmacy; Decree No. 126/2020/ND-CP guiding the Law on Tax Administration, as amended by Decree No. 91/2022/ND-CP; and Decree No. 14/2023/ND-CP on the functions, tasks, powers and organizational structure of the Ministry of Finance.

At the proposal of the Director of the Tax Policy Department, the Minister of Finance promulgates this Circular on fee rates, collection, payment, management and use of fees in the pharmaceutical and cosmetic sectors.

Article 1. Scope and regulated entities

1. This Circular provides for fee rates and the regime for collection, payment, management and use of fees in the pharmaceutical and cosmetic sectors, including fees for assessment of marketing authorization, import licensing, certification and declaration dossiers in pharmaceuticals and cosmetics; and fees for assessment of standards and eligibility for practice and business in pharmaceuticals and cosmetics.

2. This Circular applies to fee payers, fee-collecting organizations and other organizations and individuals related to the collection, payment, management and use of fees in the pharmaceutical and cosmetic sectors.

Article 2. Fee payers

Organizations and individuals submitting applications requesting competent state authorities to perform tasks in the pharmaceutical and cosmetic sectors specified in the fee schedule enclosed with this Circular are fee payers.

Article 3. Fee-collecting organizations

The Ministry of Health, units under the Ministry of Health assigned to perform fee-collecting tasks, and provincial Departments of Health performing the fee-collecting tasks specified in the enclosed fee schedule are fee-collecting organizations.

Article 4. Fee rates

Fee rates in the pharmaceutical and cosmetic sectors shall comply with the fee schedule enclosed with this Circular.

Article 5. Fee declaration and payment

1. Fee payers shall pay fees at the rates specified in Article 4 of this Circular to fee-collecting organizations by the methods provided in Circular No. 74/2022/TT-BTC on methods, deadlines for collection, payment and declaration of fees and charges under the authority of the Ministry of Finance.

2. No later than Thursday every week, fee-collecting organizations shall transfer the fees collected in the previous week to their fee account pending remittance to the state budget opened at the State Treasury. Fee declaration, collection, payment and finalization shall comply with Circular No. 74/2022/TT-BTC; fees collected by central agencies shall be paid into the central budget, and fees collected by local agencies shall be paid into local budgets.

Article 6. Management and use of fees

1. Fee-collecting organizations shall remit all collected fees to the state budget. Expenses for performance of tasks and fee collection shall be funded by the state budget in the approved expenditure estimates of the fee-collecting organizations.

2. Where the fee-collecting organization is a state agency allowed to cover operating expenses from fee revenue under Clause 1 Article 4 of Decree No. 120/2016/ND-CP, it may retain 70% of collected fees for permitted expenses and shall remit 30% to the state budget according to the applicable state budget classification.

Article 7. Implementation provisions

1. This Circular takes effect from 01 August 2023.

2. This Circular replaces Circular No. 277/2016/TT-BTC dated 14 November 2016 and Circular No. 114/2017/TT-BTC dated 24 October 2017.

3. Matters on fee collection, payment, management, use, receipts and public disclosure not provided in this Circular shall comply with the Law on Fees and Charges, the Law on Tax Administration and relevant guiding documents.

4. If any legal document cited in this Circular is amended, supplemented or replaced, the new document shall apply.

5. Difficulties arising during implementation should be reported to the Ministry of Finance for study and further guidance.

FOR THE MINISTER
DEPUTY MINISTER

Cao Anh Tuan

FEE SCHEDULE IN THE PHARMACEUTICAL AND COSMETIC SECTORS

Issued together with Circular No. 41/2023/TT-BTC dated 12 June 2023. Rate unit: VND 1,000.

No.	Fee item	Unit	Rate (VND 1,000)
I	Fees for assessment of marketing authorization, import licensing, certification and declaration dossiers in pharmaceuticals and cosmetics
1	Assessment and certification of information/advertising contents for drugs and cosmetics	Application	1,600
2.a	Assessment for issuance of marketing authorization for drugs, except traditional herbal ingredients specified at Point b of this item	Application	11,000
2.b	Assessment for issuance of marketing authorization for medicinal materials and traditional herbal ingredients	Application	5,500
2.c	Assessment for renewal of marketing authorization for drugs, medicinal materials and traditional herbal ingredients	Application	4,500
2.d	Assessment for changes/supplements to marketing authorization for drugs, medicinal materials and traditional herbal ingredients	Application	1,500
3	Assessment for import permits for drugs without marketing authorization in Vietnam, except import cases specified in Articles 67, 72, 73, 74 and 75 of Decree 54/2017/ND-CP	Item	1,200
4	Assessment of cosmetic product notification dossiers and declaration of standards/quality of medicinal materials	Application	500
II	Fees for assessment of standards and eligibility for practice and business in pharmaceuticals and cosmetics
1	Assessment of cosmetic manufacturing conditions for issuance of certificate of CGMP-ASEAN compliance	Facility	30,000
2	Assessment of conditions and Good Manufacturing Practice (GMP) compliance for drugs, medicinal materials, medicinal herbs and traditional herbal ingredients, including initial, maintenance and change-control assessment at the facility	Facility	30,000
3	Assessment of conditions and GMP compliance for pharmaceutical packaging at the facility	Facility	30,000
4	Assessment of conditions and Good Storage Practice (GSP) compliance for drugs, medicinal ingredients, medicinal herbs and traditional herbal ingredients, including initial, maintenance and change-control assessment at the facility	Facility	21,000
5	Assessment of conditions and Good Laboratory Practice (GLP) compliance, including initial, maintenance and change-control assessment at the facility	Facility	21,000
6	Assessment of Good Distribution Practice (GDP) compliance for wholesale establishments, including initial, maintenance and change-control assessment at the facility	Facility	4,000
7	Assessment of pharmacy practice certificate dossiers: issuance, re-issuance and adjustment	Application	500
8.a	Assessment of conditions and Good Pharmacy Practice (GPP) compliance for retail drug establishments located in difficult and extremely difficult socio-economic areas under Decree 31/2021/ND-CP	Facility	500
8.b	Assessment of conditions and Good Pharmacy Practice (GPP) compliance for retail drug establishments in other areas	Facility	1,000
9	Assessment of declared and re-declared drug prices	Application	800
10	Assessment of cosmetic manufacturing conditions for issuance of certificate of eligibility for cosmetic manufacturing	Facility	6,000
11.a	Assessment of conditions of specialized retail establishments for medicinal herbs, herbal medicines and traditional medicines, including traditional herbal ingredients, in difficult and extremely difficult areas under Decree 31/2021/ND-CP	Facility	300
11.b	Assessment of conditions of specialized retail establishments for medicinal herbs, herbal medicines and traditional medicines, including traditional herbal ingredients, in other areas	Facility	750
12	Assessment of compliance with Good Agricultural and Collection Practice (GACP) and principles/standards for exploitation of natural medicinal materials, except cases eligible for fee support under Clause 2 Article 6 of Decree 65/2017/ND-CP	Application	9,000
13.a	Dossier assessment for GMP compliance of overseas drug and medicinal-ingredient manufacturers when registering products for circulation in Vietnam	Application	2,250
13.b	On-site assessment at overseas drug and medicinal-ingredient manufacturing facilities, excluding mission expenses such as travel, lodging allowance, meals, incidental expenses and insurance as prescribed	Facility	200
14	Assessment for issuance of Certificate of Free Sale (CFS) for cosmetics	Item	500
15	Assessment of eligibility of bioequivalence trial facilities, including initial, maintenance and change-control assessment at the facility	Facility	21,000
16	Assessment of dossiers for initial and maintenance evaluation of Good Clinical Practice compliance in clinical drug trials	Application	30,000

Operational note: this English version is provided for reference. For official application, use the Vietnamese signed PDF and verify current legal effect at the time of dossier submission.

TECHNICAL TERMS

Appraisal fee: a state fee paid for regulatory review of a dossier or facility condition.
CFS: Certificate of Free Sale.
GMP/GSP/GLP/GDP/GPP: good practice standards in manufacturing, storage, laboratory, distribution and retail pharmacy.
CGMP-ASEAN: ASEAN cosmetic good manufacturing practice standard.

FAQ

When does the Circular take effect?

From 01 August 2023.

Does it change HS codes or import duty?

No. It governs appraisal fees. HS classification and import duty must be reviewed separately.

How much is the cosmetic product notification appraisal fee?

VND 500,000 per dossier.

Should later amendments be checked?

Yes, because the validity status may have changed for parts of the Circular.

SOLUTION FROM TGIMEX

Legal screening

Identify the applicable procedure and the currently valid fee item.

Document control

Cross-check invoice, packing list, C/O, CFS, LOA, formula, label, GMP/CGMP and fee receipts.

Operational coordination

Build a pre-ETA timeline for dossier submission, fee payment and customs clearance.

Post-clearance records

Archive regulatory and fee evidence for future inspections.

COSMETICS – PERSONAL CARE (BY POLICY), LEGAL DOCUMENTS, MINISTRY OF FINANCE & CUSTOMS, MINISTRY OF HEALTH

Circular 41/2023/TT-BTC: Fees in pharmaceuticals and cosmetics for import-export compliance

CIRCULAR 41/2023/TT-BTC: FEES IN PHARMACEUTICALS AND COSMETICS – OPERATIONAL NOTES FOR IMPORTERS