Circular No. 41/2023/TT-BTC stipulates the fee collection levels in the pharmaceuticals and cosmetics sector, including fees for the examination and approval of circulation permits, importation, and confirmation of advertising information for pharmaceuticals and cosmetics; as well as fees for the examination of standards and conditions for business operations in this field.
적용 범위
The Circular applies to organizations and individuals operating in the pharmaceuticals and cosmetics sector in Vietnam.
핵심 사항
- Fees for the examination and approval of circulation permits, importation, and confirmation of advertising information for pharmaceuticals and cosmetics range from VND 500,000 to VND 11,000,000 depending on the type of application.
- Fees for the examination of standards and conditions for business operations in the pharmaceuticals and cosmetics sector range from VND 4,000,000 to VND 30,000,000 depending on the type of application.
- The specific amounts of these fees are detailed in the Fee Collection Schedule attached to the Circular.
- ngayhieuLucvaThoiHanHieuLuc
- Effective Date: The Circular takes effect from the date of issuance (June 12, 2023). Duration of Effectiveness: No specific duration is set, applicable until a new document replaces it.
- thanhLyVanBanCu
- This Circular abolishes Circular No. 95/2016/TT-BTC dated July 14, 2016, issued by the Ministry of Finance regarding the establishment of fee levels for the examination and approval of circulation permits, importation, and confirmation of advertising information for pharmaceuticals and cosmetics; as well as Circular No. 83/2015/TT-BYT dated October 29, 2015, issued by the Ministry of Health regarding the establishment of fee levels for the examination of standards and conditions for business operations in the pharmaceuticals and cosmetics sector.
🌐 이 문서의 사회적 영향
- Ensuring the quality of pharmaceuticals and cosmetics products circulating in the market.
- Providing a clear legal basis for the collection of examination fees in public health.
- Creating favorable conditions for enterprises operating in the pharmaceuticals and cosmetics sector to comply with regulations on standards and conditions for business operations.
❓ 자주 묻는 질문
Which organizations and individuals must pay fees under this Circular?
All organizations and individuals operating in the pharmaceuticals and cosmetics sector in Vietnam must comply with the fee payment regulations stipulated in this Circular.
What types of fees are specifically defined?
The Circular specifies detailed fees such as: Fees for the examination and approval of circulation permits, importation; fees for the examination of standards and conditions for business operations in the pharmaceuticals and cosmetics sector.
Are there any supports for establishments operating in difficult areas?
For establishments located in areas with difficult economic and social conditions, the fee levels are reduced compared to the general provisions.
전문
MINISTRY OF FINANCE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
Number: 41/2023/TT-BTC
Hanoi, June 12, 2023
CIRCULAR
Regulations on the level of collection, collection system, payment, management
and the use of fees in the pharmaceuticals and cosmetics sector
Pursuant to the Law on Fees and Charges dated November 25, 2015;
Pursuant to the State Budget Law dated June 25, 2015,
BASED ON THE PHARMACEUTICAL LAW dated April 6, 2016;
Pursuant to the Law on Tax Administration dated June 13, 2019,
Pursuant to the Decree No. 120/2016/NĐ-CP dated August 23, 2016 of the Government detailing and guiding the implementation of certain articles of the Law on Fees and Stamp Duties;
Pursuant to Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing certain provisions and implementing measures of the Medicine Law;
Pursuant to Decree No. 126/2020/NĐ-CP dated October 19, 2020 of the Government detailing certain provisions of the Law on Tax Administration; and Decree No. 91/2022/NĐ-CP dated October 30, 2022 of the Government amending and supplementing certain provisions of Decree No. 126/2020/NĐ-CP;
Pursuant to Decree No. 14/2023/NĐ-CP dated April 20, 2023, issued by the Government, stipulating the functions, tasks, powers, and organizational structure of the Ministry of Finance;
At the proposal of the Director of the Department of Tax Policy,
The Minister of Finance issues this Circular stipulating the rates of collection, procedures for collection, payment, management, and use of fees in the pharmaceuticals and cosmetics sector.
Article 1. Scope of Regulation and Applicability
1. This Circular stipulates the rates of collection, procedures for collection, payment, management, and use of fees in the pharmaceuticals and cosmetics sector, including: Fees for the examination and approval of circulation permits, importation, confirmation, and announcement in the pharmaceutical and cosmetic sectors; fees for the examination of standards and conditions for practice and business in the pharmaceutical and cosmetic sectors.
2. This Circular applies to fee payers, organizations collecting fees, and other organizations and individuals related to the collection, payment, management, and use of fees in the pharmaceuticals and cosmetics sector.
Article 2. Persons Paying Fees
Organizations and individuals submitting applications to state management agencies to perform tasks in the pharmaceuticals and cosmetics sector as specified in the Fee Collection Rate Table attached to this Circular are fee payers.
Article 3. Fee Collection Organizations
The Ministry of Health or units under the Ministry of Health assigned by the Ministry of Health to perform tasks subject to fee collection as specified in the Fee Collection Rate Table attached to this Circular, and provincial Departments of Health performing such tasks are fee collection organizations.
Article 4. Fee Rates
The rates of fees in the pharmaceuticals and cosmetics sector shall be implemented according to the Fee Collection Rate Table attached to this Circular.
Article 5. Declaration and Payment of Fees
1. Fee payers must declare and pay fees at the rate specified in Article 4 of this Circular to the fee collection organization in accordance with the form prescribed in Circular No. 74/2022/TT-BTC dated December 22, 2022 of the Minister of Finance regarding the form, time limit, declaration, and payment of various fees and charges within the authority of the Ministry of Finance.
2. No later than the fifth day of each week, the fee collection organization must deposit the collected fees from the previous week into its fee account awaiting submission to the State Treasury opened at the National Treasury. The fee collection organization shall declare, collect, pay, and settle fees in accordance with Circular No. 74/2022/TT-BTC (fees collected by central agencies are submitted to the central budget, fees collected by local agencies are submitted to the local budget).
Article 6. Management and Use of Fees
1. 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 allocated in the budget of the fee collection organization according to the state budget expenditure regulations.
2. In cases where the fee collection organization is a state agency that has been allocated operational costs from fee revenues according to Clause 1, Article 4 of 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, it may retain 70% of the collected fees to cover expenses for performing tasks and collecting fees as stipulated in Article 5 of Decree No. 120/2016/NĐ-CP, and remit 30% of the collected fees to the state budget according to the chapters and sub-items of the current State Budget Classification.
Article 7. Implementation Provisions
1. This Circular takes effect from August 1, 2023.
2. This Circular replaces Circular No. 277/2016/TT-BTC dated November 14, 2016 of the Minister of Finance stipulating the rates of collection, procedures for collection, payment, management, and use of fees in the pharmaceuticals and cosmetics sector, and Circular No. 114/2017/TT-BTC dated October 24, 2017 of the Minister of Finance amending and supplementing the Fee Collection Rate Table in the pharmaceuticals and cosmetics sector issued together with Circular No. 277/2016/TT-BTC dated November 14, 2016 stipulating the rates of collection, procedures for collection, payment, management, and use of fees in the pharmaceuticals and cosmetics sector.
3. Other matters related to the collection, payment, management, use, receipt vouchers, and publicizing the fee collection system in the pharmaceuticals and cosmetics sector not mentioned in this Circular shall be carried out in accordance with the provisions of the following documents: Law on Fees and Charges; Law on Tax Administration; Decree No. 120/2016/NĐ-CP; Decree No. 126/2020/NĐ-CP dated October 19, 2020 of the Government detailing certain provisions of the Law on Tax Administration; Decree No. 91/2022/NĐ-CP dated October 30, 2022 of the Government amending and supplementing certain provisions of Decree No. 126/2020/NĐ-CP; Decree No. 11/2020/NĐ-CP dated January 20, 2020 of the Government on administrative procedures under the National Treasury; Decree No. 123/2020/NĐ-CP dated October 19, 2020 of the Government on invoices and receipts; and Circular No. 78/2021/TT-BTC dated September 17, 2021 of the Minister of Finance guiding the implementation of certain provisions of the Law on Tax Administration dated June 13, 2019 and Decree No. 123/2020/NĐ-CP dated October 19, 2020 of the Government on invoices and receipts.
4. During the implementation, if related documents cited in this Circular are amended, supplemented, or replaced, they shall be implemented according to the newly amended, supplemented, or replaced documents.
5. During the implementation process, if there are any difficulties, organizations and individuals are requested to promptly reflect them to the Ministry of Finance for research and supplementary guidance.
|
Place of Receipt: |
DEPUTY MINISTER |
TABLE OF FEE COLLECTION RATES IN THE PHARMACEUTICALS AND COSMETICS SECTOR
(Attached to Circular No. 41/2023/TT-BTC dated June 12, 2023 of the Minister of Finance)
|
Item number |
Name of Fee |
Unit of Measurement |
Rate of Collection (1,000 VND) |
|
I |
Examination and Approval Fee for Circulation Permits, Importation, Confirmation, and Announcement in the Pharmaceutical and Cosmetic Sectors |
|
|
|
1 |
Examination and Confirmation Fee for Content Information and Advertising of Medicines and Cosmetics |
File |
1.600 |
|
2 |
Examination and Approval Fee for Registration of Circulation of Medicines and Raw Materials for Medicines |
||
|
a |
Examination and Approval Fee for Registration of Circulation of Medicines (excluding traditional herbal medicines as specified in point b of this Section) |
File |
11.000 |
|
b |
Examination and Approval Fee for Registration of Circulation of Raw Materials for Medicines and Traditional Herbal Medicines |
File |
5.500 |
|
specialized agency under the People's Committee of the province/city. |
Examination and Extension Fee for Registration of Circulation of Medicines, Raw Materials for Medicines, and Traditional Herbal Medicines |
File |
4.500 |
|
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%; |
Examination and Amendment Fee for Registration of Circulation of Medicines, Raw Materials for Medicines, and Traditional Herbal Medicines |
File |
1.500 |
|
3 |
Examination and Approval Fee for Import Permit of Medicines Not Registered for Circulation in Vietnam (excluding cases of importation as provided for in Articles 67, 72, 73, 74, and 75 of Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing certain provisions and implementing measures of the Medicine Law) |
Product |
1.200 |
|
4 |
Evaluation and announcement of cosmetic products, standards, and quality of medicinal herbs |
File |
500 |
|
II |
Fees for evaluation of standards and conditions for practicing and operating in the pharmaceuticals and cosmetics sectors |
||
|
1 |
Evaluation of conditions for manufacturing cosmetics and issuance of certificates confirming compliance with ASEAN CGMP standards |
Cơ sở vật chất (nhà cửa, cơ sở hạ tầng) bảo đảm cho việc liên doanh, liên kết |
30.000 |
|
2 |
Evaluation of conditions and assessment of compliance with good manufacturing practices (GMP) for drug production, raw materials for drugs, medicinal herbs, traditional herbal medicines (assessment of compliance, maintenance assessment, change control assessment at the facility) |
Cơ sở vật chất (nhà cửa, cơ sở hạ tầng) bảo đảm cho việc liên doanh, liên kết |
30.000 |
|
3 |
Evaluation of conditions and assessment of compliance with good manufacturing practices (GMP) for pharmaceutical packaging at the facility |
Cơ sở vật chất (nhà cửa, cơ sở hạ tầng) bảo đảm cho việc liên doanh, liên kết |
30.000 |
|
4 |
Evaluation of conditions and assessment of compliance with good storage practices (GSP) for drugs, raw materials for drugs, medicinal herbs, traditional herbal medicines (assessment of compliance, maintenance assessment, change control assessment at the facility) |
Cơ sở vật chất (nhà cửa, cơ sở hạ tầng) bảo đảm cho việc liên doanh, liên kết |
21.000 |
|
5 |
Evaluation of conditions and assessment of compliance with good laboratory practices (GLP) (assessment of compliance, maintenance assessment, change control assessment at the facility) |
Cơ sở vật chất (nhà cửa, cơ sở hạ tầng) bảo đảm cho việc liên doanh, liên kết |
21.000 |
|
6 |
Evaluation of conditions and assessment of compliance with good distribution practices (GDP) for wholesale facilities (assessment of compliance, maintenance assessment, change control assessment at the facility) |
Cơ sở vật chất (nhà cửa, cơ sở hạ tầng) bảo đảm cho việc liên doanh, liên kết |
4.000 |
|
7 |
Evaluation of application files for issuance of pharmaceutical practice certificates: Issuance, reissuance, and adjustment of contents of pharmaceutical practice certificates |
File |
500 |
|
8 |
Evaluation of conditions and assessment of compliance with good pharmacy practices (GPP) for retail pharmacies (assessment of compliance, maintenance assessment, change control assessment at the facility) |
||
|
a |
For facilities located in areas with difficult socio-economic conditions as stipulated in Decree No. 31/2021/NĐ-CP dated March 26, 2021 of the Government detailing and guiding the implementation of certain provisions of the Investment Law |
Cơ sở vật chất (nhà cửa, cơ sở hạ tầng) bảo đảm cho việc liên doanh, liên kết |
500 |
|
b |
For facilities located in other areas |
Cơ sở vật chất (nhà cửa, cơ sở hạ tầng) bảo đảm cho việc liên doanh, liên kết |
1.000 |
|
9 |
Evaluation of announced drug pricing declarations and redeclarations |
File |
800 |
|
10 |
Evaluation of conditions for manufacturing cosmetics and issuance of certificates confirming compliance with cosmetic manufacturing conditions |
Cơ sở vật chất (nhà cửa, cơ sở hạ tầng) bảo đảm cho việc liên doanh, liên kết |
6.000 |
|
11 |
Evaluation of conditions for facilities specializing in retailing medicinal herbs, herbal drugs, traditional medicines (including traditional herbal medicines) |
||
|
a |
For facilities located in areas with difficult socio-economic conditions as stipulated in Decree No. 31/2021/NĐ-CP |
Cơ sở vật chất (nhà cửa, cơ sở hạ tầng) bảo đảm cho việc liên doanh, liên kết |
300 |
|
b |
For facilities located in other areas |
Cơ sở vật chất (nhà cửa, cơ sở hạ tầng) bảo đảm cho việc liên doanh, liên kết |
750 |
|
12 |
Assessment of compliance with good agricultural and collection practices (GACP) for the cultivation and harvesting of medicinal herbs and natural medicinal resource extraction principles (excluding cases where fees are supported according to Clause 2, Article 6 of Decree No. 65/2017/NĐ-CP dated May 19, 2017 of the Government on special policies regarding seedlings, capital, and technology in developing the cultivation and exploitation of medicinal herbs) |
File |
9.000 |
|
13 |
Evaluation and assessment of compliance with good manufacturing practices (GMP) for drug production and raw material production in foreign countries when registering for circulation in Vietnam |
||
|
a |
Reviewing Files |
File |
2.250 |
|
b |
Evaluation and on-site assessment at the facility (excluding travel expenses: transportation, accommodation allowances, food and incidental expenses, various insurance fees as prescribed) |
Cơ sở vật chất (nhà cửa, cơ sở hạ tầng) bảo đảm cho việc liên doanh, liên kết |
200 |
|
14 |
Evaluation and issuance of certificates of free circulation for cosmetics (CFS) |
Product |
500 |
|
15 |
Evaluation and assessment of compliance with conditions for bioequivalence testing facilities for drugs (initial assessment, maintenance assessment, change control assessment at the facility) |
Cơ sở vật chất (nhà cửa, cơ sở hạ tầng) bảo đảm cho việc liên doanh, liên kết |
21.000 |
|
16 |
Evaluation of application files for initial and maintenance assessments of compliance with good clinical trial practices for drug testing |
File |
30.000 |
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