Circular No. 41/2023/TT-BTC stipulates the levels of collection, the system of collection, payment, management, and use of fees in the pharmaceuticals and cosmetics sector.

Place of Receipt:
- Central Party Committee Secretariat;
- Prime Minister, Deputy Prime Ministers;
- Central Party Office and Party Committees;
- General Secretary's Office;
- National Assembly's Office;
- National Assembly;
- Financial and Budget Committee;
- President's Office;
- Government Office;
- Supreme People's Procuracy;
- Supreme People's Court;
- State Audit Agency;
- Ministries, agencies equivalent to ministries, and government agencies;
- Provincial People's Councils, Provincial People's Committees;
- Central Agencies of Associations and Mass Organizations;
- Provincial Departments of Finance, National Treasury, Provincial Tax Departments;
- Department of Legal Normative Documents Inspection, Ministry of Justice;
- Official Gazette, Government Electronic Portal;
- Ministry of Finance Electronic Portal;
- Units under the Ministry of Finance;
- To be filed: VT, Department of Revenue (300b).

DEPUTY MINISTER
DEPUTY MINISTER
(Signed)



Cao Anh Tuấn

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