Circular No. 277/2016/TT-BTC stipulates the level of collection, collection system, payment, management, and use of fees in the pharmaceuticals and cosmetics sector. This document applies to organizations and individuals related to the implementation of work within the scope of pharmaceuticals and cosmetics.
适用范围
Organizations and individuals when being appraised for permission to circulate, import, or confirm information in the pharmaceuticals and cosmetics sector; production and business establishments of medicines and cosmetics.
要点
- Appraisal to confirm advertising content: VND 1,800,000 per file
- Appraisal for circulation permit for initial registration: VND 5,500,000 per file
- Appraisal for product announcement in cosmetics: VND 500,000 per item
- Appraisal for production standards and conditions for medicines and herbal drugs (GMP): VND 20,000,000 per establishment
- Authentication of tender list: VND 1,000,000 per file
- Cultivation of medicinal herbs according to GACP standards: VND 6,000,000 per file
🌐 本文件的社会影响
- Strengthening the management of pharmaceutical and cosmetic product quality.
- Ensuring consumer safety through strict control of production and business processes.
❓ 常见问题
What is the fee for the appraisal of the initial registration of a drug circulation permit?
VND 5,500,000 per file
What is the fee for the appraisal of production standards and conditions for cosmetics (GMP)?
VND 20,000,000 per establishment
全文
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MINISTRY OF FINANCE |
SOCIALIST REPUBLIC OF VIET NAM |
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Number: 277/2016/TT-BTC |
Hanoi, November 14, 2016 |
CIRCULAR
REGULATIONS ON THE LEVEL OF COLLECTION, COLLECTION REGIME, PAYMENT, MANAGEMENT AND USE OF FEES IN THE FIELD OF PHARMACEUTICALS AND BEAUTY PRODUCTS
CamendPursuant to the Law on Fees and Charges dated November 25, 2015;
Pursuant to the State Budget Law dated June 25, 2015;
Pursuant to Decree No. 120/2016/NĐ-CP dated August 23, 2016 of the Government detailing and guiding the implementation of certain provisions of the Law on Fees and Charges;No. Pursuant to Decree No. 215/2013/NĐ-CP dated December 23, 2013 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Finance; construction costs;;
Pursuant to the tax list, Bhereby promulgates this Circular regulating the level of collection, collection regime, payment, management and use of fees in the field of pharmaceuticals and beauty products.
At the proposal of the Director of the Department of Tax Policy,"b) In addition to the lists of public services issued according to the provisions of Clause 2, Article 4 of this Decree, specialized agencies under provincial People's Committees shall report to the provincial People's Committee for decision-making on amending, supplementing, or issuing the list of public services funded by the state budget within their jurisdiction and consistent with the local budget capacity within the approved budget by the Provincial People's Assembly, and send it to the Ministry of Finance and relevant ministries and sectors for supervision during implementation."Article 1. This Circular regulates the level of collection, collection regime, payment, management and use of fees in the field of pharmaceuticals and beauty products.
1. Selling state property through public listing."b) In addition to the lists of public services issued according to the provisions of Clause 2, Article 4 of this Decree, specialized agencies under provincial People's Committees shall report to the provincial People's Committee for decision-making on amending, supplementing, or issuing the list of public services funded by the state budget within their jurisdiction and consistent with the local budget capacity within the approved budget by the Provincial People's Assembly, and send it to the Ministry of Finance and relevant ministries and sectors for supervision during implementation."Article 2. This Circular applies to fee payers, organizations collecting fees in the field of pharmaceuticals and beauty products, and other related organizations and individuals concerning the collection, payment, management and use of fees in the field of pharmaceuticals and beauty products.
Article 1. Scope of Regulation and Applicability
Organizations managing state agencies that perform tasks related to the field of pharmaceuticals and beauty products as specified in the Fee Schedule attached hereto must pay the fees."b) In addition to the lists of public services issued according to the provisions of Clause 2, Article 4 of this Decree, specialized agencies under provincial People's Committees shall report to the provincial People's Committee for decision-making on amending, supplementing, or issuing the list of public services funded by the state budget within their jurisdiction and consistent with the local budget capacity within the approved budget by the Provincial People's Assembly, and send it to the Ministry of Finance and relevant ministries and sectors for supervision during implementation." The Drug Administration; the Traditional Medicine and Drugs Administration (Ministry of Health) and the Department of Health of provinces and centrally governed cities implementing tasks specified for fee collection in the Fee Schedule attached hereto are the fee collection organizations.
The level of fees in the field of pharmaceuticals and beauty products shall be implemented according to the provisions in the Fee Schedule attached hereto.policiesWithin the latest by the fifth day of each week, the fee collection organization must deposit the amount of fees collected from the previous week into the account for pending budget payments opened at the State Treasury. organize credit institutions, foreign bank branches are responsible for organizing the implementation of this Circular.The fee collection organization shall declare and pay the monthly collected fees, settle accounts annually according to the guidance provided in Clause 3 Article 19, Clause 2 Article 26 of Circular No. 156/2013/TT-BTC dated November 6, 2013 of the Minister of Finance guiding the implementation of certain provisions of the Law on Tax Administration; the Law Amending and Supplementing Certain Provisions of the Law on Tax Administration and Decree No. 83/2013/NĐ-CP dated July 22, 2013 of the Government.
Article 2. Persons Paying Fees
Subject measures The fee collection organization shall remit all collected fees to the state budget. The cost of expenses for performing tasks and collecting fees shall be covered by the state budget within the organization's budget according to the state budget expenditure regulations.ngIn cases where the fee collection organization is a state agency allocated costs for activities from fee revenues according to Clause 1 Article 4 of Decree No. 120/2016/NĐ-CP dated August 23, 2016 of the Government, it may retain 70% of the collected fees to cover costs for expenditures as stipulated in Article 5 of Decree No. 120/2016/NĐ-CP dated August 23, 2016 of the Government. Remit 30% of the collected fees to the state budget according to the chapters and sub-items of the current State Budget Classification.concerning the classification and determination of state management authority in the field of crop production This Circular takes effect from January 1, 2017 and replaces the relevant fee collection provisions in the field of pharmaceuticals and beauty products stipulated in Circular No. 03/2013/TT-BYT dated January 8, 2013 of the Minister of Health regarding fees for business trade condition assessment; professional standards and conditions assessment; license issuance fees for medical equipment, drug imports and exports, practice certificates, and operation permits for medical facilities.
Article 3. Fee Collection Organizations
Other provisions related to the collection, payment, management, use, receipt vouchers, and publicizing the fee collection regime not mentioned in this Circular shall be implemented according to the Law on Fees and Charges, Decree No. 120/2016/NĐ-CP dated August 23, 2016 of the Government; Circular No. 156/2013/TT-BTC dated November 6, 2013 of the Minister of Finance; Circulars of the Ministry of Finance prescribing the printing, issuance, management, and use of various types of receipts for fees and charges under state budget and other amending or replacing documents (if any). standards During the implementation process, if there are difficulties, please promptly reflect them to the Ministry of Finance for research and supplementary guidance.
Article 4. Fee Rates
(Issued together with Circular No. 277/2016/TT-BTC dated November 14, 2016 of the Minister of Finance)
Article 5. Declaration and Payment of Fees
Fees for approval determination
Issuance, importation, confirmation, announcement in the field of pharmaceuticals and beauty products Determination of issuance approval for drugs,
Article 6. Management and Use of Fees
Raw materials for drugs
Approval issuance for drug and raw material registration for first-time registration, re-registration Approval issuance determination for drug and raw material registration for extension
Article 7. Implementation Organization
Approval issuance determination for drug and raw material registration for change/supplement registration of drugs and raw materials already having issuance approval (major changes, minor changes)
(including minor changes requiring approval and changes made through notification)For power plants invested under the Build-Operate-Transfer (BOT) model, n is determined according to the operational period of the power plant stipulated in the BOT contract.Approval issuance determination for finished drug importation without registration number (excluding rare drug imports, special treatment needs, epidemic prevention drugs, disaster relief drugs, health program drugs, aid drugs, non-commercial trade drugs, sample registration drugs, testing sample drugs, clinical trial drugs, bioequivalence test drugs, etc.)organize credit institutions, foreign bank branches are responsible for organizing the implementation of this Circular. Approval issuance determination for traditional herbal medicine and medicinal herb importsứApproval issuance determination for cosmetic product announcement, herbal standard announcementhStandard and business operation condition determination fees in the field of pharmaceuticals and beauty productsâCosmetic production standard and condition determination for issuing GMP certification, amended and supplemented by Decree No. 109/2025/NĐ-CP and Decree No. 193/2025/NĐ-CPm, amended and supplemented by Decree No. 109/2025/NĐ-CP and Decree No. 193/2025/NĐ-CP GMP certification issuanceFor power plants invested under the Build-Operate-Transfer (BOT) model, n is determined according to the operational period of the power plant stipulated in the BOT contract.ASEAN CGMP certification issuance
c) Providing technical assistance to provinces and centrally administered cities under their jurisdiction in developing local technical standards on clean water quality.FPharmaceutical and herbal medicine production standard and condition determination (GMP)shall Pharmaceutical and packaging material production standard and condition determinationâPharmaceutical and herbal medicine storage standard and condition determination (GSP)
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Place of Receipt: |
DEPUTY MINISTER |
TABLE OF FEE COLLECTION RATES IN THE PHARMACEUTICALS AND COSMETICS SECTOR
Pharmaceutical testing standard and condition determination (GLP)1Traditional Chinese medicine, herbal medicine production standard and condition determination
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Quarter (1) |
Name of fee, charge |
Unit of Measurement |
Rate of Collection (1,000 VND) |
|
I |
Herbal medicine application example đGMP implementation roadmap stillborn Wholesale drug business condition determination (GDP) |
|
|
|
1 |
Examination and Confirmation Fee for Content Information and Advertising of Medicines and Cosmetics |
File |
1.800 |
|
2 |
THErime Minister cPharmacy practice certificate issuance determination For power plants invested under the Build-Operate-Transfer (BOT) model, n is determined according to the operational period of the power plant stipulated in the BOT contract.Retail pharmacy business condition and standard determination (GPP) or pharmacy practice condition and standard determination for retail pharmacies not yet required to implement good pharmacy practice principles according to the roadmap |
|
|
|
2.1 |
Appraisal specialized agency under the People's Committee of the province/city.Retail pharmacy business condition and standard determination (GPP) for retail pharmacies located in difficult areas, mountainous regions, islands |
File |
5.500 |
|
2.2 |
Drug price announcement fee:Declaration, re-declarationTo announce lists serving bidding procedures: |
File |
3.000 |
|
2.3 |
Review the issuance permit for applications to change or supplement registered information of drugs that already have circulation permits (including minor changes and changes notified in a declaration form).ệu làm thuốc đã có giấy phép lưu hành (thay đổi lớn, thay đổi mới) l(bao gồm thay đổi nhỏ cấp)ỏ n phê duyệt)ầệt và thay đổi theo hình thức thông báo))yp giấy phép nhập khẩu thuốc thành phẩm chưa có số đăng ký (trừ trường hợp nhập khẩu thuốc hiếm, thuốc cho nhu cầu điều trị đặc biệt, thuốc phòng chống dịch, thiên tai, thu) |
File |
1.000 |
|
3 |
Review the issuance of import permits for finished drugs without registration numbers (excluding rare drug imports, drugs for special treatment needs, epidemic prevention drugs, disaster relief drugs, health program drugs, aid drugs, non-trade drugs, sample registration drugs, testing sample drugs, clinical trial drugs, bioequivalence test drugs, etc.).of the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Home Affairsc cho các chương trình y tế, thuốc viện trợ, thuốc phi mậu dịch, thuốc làm mẫu đăng ký, mẫu kiểm nghiệm, thuốc cho thử tương đương sinh học,...)N ||| declaration of customs import procedures.ỹ phẩm, công bố tiêu chuẩn dược liệunationalh tiêu chuẩn, điều kiện hành nghề, kinh doanh thuộc lĩnh vực dược, mỹ phẩmNo.ng nhận GMP mỹ phẩm theo)đổ hủ) |
Product |
800 |
|
4 |
Review the issuance of import permits for medicinal herbs and traditional medicines. |
Product |
200 |
|
5 |
Review the announcement of cosmetic standards and herbal medicine standards.No. Quarter I (Q t sMP) |
Product |
500 |
|
II |
Review standards and business conditions within the pharmaceuticals and cosmetics sectors.t s This Circular promulgates the Regulation on Distance Learning for Bachelor's Degree Programs.For power plants invested under the Build-Operate-Transfer (BOT) model, n is determined according to the operational period of the power plant stipulated in the BOT contract.Thẩm định tiêu chuẩn)itselfvà điều kiện sản xuất thuốc cổ truyền, thuốc dược liệu,) |
|
|
|
1 |
Appraisal organize credit institutions, foreign bank branches are responsible for organizing the implementation of this Circular.Standards and production conditions for cosmetics to issue Good Manufacturing Practice (GMP) certification.ứdược)âocess xg lộ trình triển khai GMP) ASEAN CGMP. |
Cơ sở vật chất (nhà cửa, cơ sở hạ tầng) bảo đảm cho việc liên doanh, liên kết |
20.000 |
|
2 |
Review standards and production conditions for drugs and herbal medicines (GMP).ofThẩm định) |
Cơ sở vật chất (nhà cửa, cơ sở hạ tầng) bảo đảm cho việc liên doanh, liên kết |
20.000 |
|
3 |
Review standards and production conditions for pharmaceutical packaging. |
Cơ sở vật chất (nhà cửa, cơ sở hạ tầng) bảo đảm cho việc liên doanh, liên kết |
20.000 |
|
4 |
ng chỉ hành nghề dược)For power plants invested under the Build-Operate-Transfer (BOT) model, n is determined according to the operational period of the power plant stipulated in the BOT contract.Review standards and storage conditions for drugs and herbal medicines (Good Storage Practices - GSP). |
Cơ sở vật chất (nhà cửa, cơ sở hạ tầng) bảo đảm cho việc liên doanh, liên kết |
14.000 |
|
5 |
ng chỉ hành nghề dược)For power plants invested under the Build-Operate-Transfer (BOT) model, n is determined according to the operational period of the power plant stipulated in the BOT contract.Review standards and testing conditions for drugs (Good Laboratory Practices - GLP). |
Cơ sở vật chất (nhà cửa, cơ sở hạ tầng) bảo đảm cho việc liên doanh, liên kết |
14.000 |
|
6 |
Thẩm định điều kiện, tiêu chuẩn bán)For power plants invested under the Build-Operate-Transfer (BOT) model, n is determined according to the operational period of the power plant stipulated in the BOT contract. ẻ) tại các) Apply the implementation timeline for GMP.For power plants invested under the Build-Operate-Transfer (BOT) model, n is determined according to the operational period of the power plant stipulated in the BOT contract.c địa bàn thuộc vùng khó khăn, miền núi, hải đảo) |
Cơ sở vật chất (nhà cửa, cơ sở hạ tầng) bảo đảm cho việc liên doanh, liên kết |
6.000 |
|
7 |
Review business conditions for wholesale drug establishments (Good Distribution Practices - GDP). |
Cơ sở vật chất (nhà cửa, cơ sở hạ tầng) bảo đảm cho việc liên doanh, liên kết |
4.000 |
|
8 |
kê khai, kê khai lại)t s Review applications for pharmaceutical practice licenses.ứng chỉ hành nghề dược |
File |
500 |
|
9 |
kê khai, kê khai lại)t s Review retail drug sale conditions (Good Pharmacy Practices - GPP) or pharmacy practice conditions for retail drug establishments not yet required to follow good pharmacy practice principles according to the implementation timeline. |
Cơ sở vật chất (nhà cửa, cơ sở hạ tầng) bảo đảm cho việc liên doanh, liên kết |
1.000 |
|
10 |
Thẩm định điều kiện, tiêu chuẩn bán lẻ organize credit institutions, foreign bank branches are responsible for organizing the implementation of this Circular.Review retail drug sale conditions (GPP) for establishments located in difficult areas, mountainous regions, and islands.ẻ tại cJune 2024;c địa bàn thuộc vùng khó khăn, miền núi, hải đảo |
Cơ sở vật chất (nhà cửa, cơ sở hạ tầng) bảo đảm cho việc liên doanh, liên kết |
500 |
|
11 |
kê khai, kê khai lại)t s Review the announcement of drug prices: initial declaration, re-declaration. |
|
|
|
11.1 |
3. Amend Clause 3 Article 2 as follows:development kê khai, kê khai lại |
File |
100 |
|
11.2 |
To announce lists serving bidding processes: |
File |
|
|
a |
For original brand drugs; the list of medicines produced at pharmaceutical manufacturing facilities that have obtained a certificate of compliance with WHO/GMP standards issued by the Ministry of Health of Vietnam and authorized for circulation by the competent authority of the participating country CH; IThe list of medicines produced from raw materials (active ingredients) manufactured in countries participating in ICH and Australia; The list of medicines produced from raw materials (active ingredients) certified with a CEP certificate; |
File |
1.500 |
|
b |
For bioequivalent medicines; |
Hồ Administrative Procedure: Recognition of forest tree planting seed sources |
2.500 |
|
specialized agency under the People's Committee of the province/city. |
For pharmaceutical manufacturing facilities that meet GMP-PIC/s and GMP-EU standards; |
File |
450 |
|
For coal-fired thermal power plants where the enterprise holds 100% of the registered capital and uses 100% of its own capital to invest in the project approved by the competent authority, E is determined as 100%; |
The fee for reviewing to publish the List of contractors meeting the requirements of capacity, experience, and reputation in bidding for medicinal herbs and traditional herbal medicines, as decided by the Minister of Health; |
File |
1.000 |
|
12 |
Reviewing the application for issuing a drug promoter card; |
Hồ Administrative Procedure: Recognition of forest tree planting seed sources |
200 |
|
13 |
THErime Minister cDetermining the conditions for producing cosmetics to issue a Certificate of Compliance for Cosmetic Production Conditions; |
Cơ sở vật chất (nhà cửa, cơ sở hạ tầng) bảo đảm cho việc liên doanh, liên kết |
6.000 |
|
14 |
Reviewing the standards and conditions for operating a business in medicinal herbs, traditional Chinese medicine, and traditional herbal medicines (including traditional herbal medicines); |
|
|
|
a |
For pharmaceutical businesses in provinces and centrally governed cities; central provinces;logoMidland provinces; |
Cơ sở vật chất (nhà cửa, cơ sở hạ tầng) bảo đảm cho việc liên doanh, liên kết |
500 |
|
b |
For pharmaceutical businesses in mountainous provinces, remote areas, and far-flung regions; |
Cơ sở vật chất (nhà cửa, cơ sở hạ tầng) bảo đảm cho việc liên doanh, liên kết |
200 |
|
15 |
Reviewing the standards and conditions for cultivating and harvesting medicinal herbs according to the GACP principle; |
File |
6.000 |
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