Circular 41/2023/TT-BTC charges relating to pharmaceuticals and cosmetics

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ATTRIBUTE

Circular No. 41/2023/TT-BTC dated June 12, 2023 of the Ministry of Finance prescribing the rates, collection, remittance, management and use of the charges relating to pharmaceuticals and cosmetics
Issuing body: Ministry of FinanceEffective date:
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Official number:41/2023/TT-BTCSigner:Cao Anh Tuan
Type:CircularExpiry date:Updating
Issuing date:12/06/2023Effect status:
Known

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Fields:Food and drug , Medical - Health , Tax - Fee - Charge

SUMMARY

Charge for appraisal for grant of registration certificates of free sale for drugs: VND 11,000,000/dossier

On June 12, 2023, the Ministry of Finance issues the Circular No. 41/2023/TT-BTC prescribing the rates, collection, remittance, management and use of the charges relating to pharmaceuticals and cosmetics. To be specific:

1. Charges for appraisal for grant of licenses of free sale, import, certification, and publication in the fields of pharmaceuticals and cosmetics: from VND 500,000 to VND 11,000,000. In which:

  • Charge for appraisal for grant of registration certificates of free sale for drugs (except for traditional medicaments): VND 11,000,000/dossier
  • Charge for appraisal for grant of registration certificates of free sale for drug materials, traditional medicaments: VND 5,500,000/dossier
  • Charge for appraisal for grant of import licenses of drugs that do not have registration certificates of free sale for drugs in Vietnam (except some cases): VND 1,200,000/item

2. Charges for appraisal of standards and conditions for practice and business relating to pharmaceuticals and cosmetics: from VND 200,000 to VND 30,000,000. Some specified charges as follows:

  • Charge for appraisal of dossiers for grant of pharmacy practice certificates (grant, re-grant, modification of pharmacy practice certificates): VND 500,000/dossier
  • Charge for appraisal of conditions and assessment of satisfying the good practices of manufacturing of pharmaceutical package at the facility: VND 30,000,000/facility

3. Charge collectors shall remit the entire collected charge amount into the state budget.

In case charge collectors are state agencies allowed to have their operating expenses covered by charge revenues, they may retain 70% of collected charge amount for covering expenditure contents as specified; and remit 30% of the collected amount into the state budget.

This Circular takes effect on August 01, 2023.

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Effect status: Known

THE MINISTRY OF FINANCE

__________

 

No. 41/2023/TT-BTC

THE SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

________________________

 

Hanoi, June 12, 2023

 

CIRCULAR

Prescribing the rates, collection, remittance, management and use of the charges relating to pharmaceuticals and cosmetics

_______________________________

 

Pursuant to the Law on Charges and Fees dated November 25, 2015;

Pursuant to the Law on the State Budget dated June 25, 2015;

Pursuant to the Law on Pharmacy dated April 6, 2016;

Pursuant to the Law on Tax Administration dated June 13, 2019;

Pursuant to the Government’s Decree No. 120/2016/ND-CP dated August 23, 2016, on detailing and guiding the implementation of a number of articles of the Law on Charges and Fees;

Pursuant to the Government’s Decree No. 54/2017/ND-CP dated May 8, 2017, detailing a number of articles of and providing measures for implementing the Pharmacy Law;

Pursuant to the Government's Decree No. 126/2020/ND-CP dated October 19, 2020, detailing a number of articles of the Law on Tax Administration; the Government's Decree No. 91/2022/ND-CP dated October 30, 2022, amending and supplementing a number of articles of the Decree No. 126/2020/ND-CP;

Pursuant to the Government's Decree No. 14/2023/ND-CP dated April 20, 2023, defining 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 the Circular prescribing the rates, collection, remittance, management and use of the charges relating to pharmaceuticals and cosmetics.

 

Article 1. Scope of regulation and subjects of application

1. This Circular defines the rates and the collection, remittance, management and use of the charges relating to pharmaceuticals and cosmetics, including: Charges for appraisal for grant of free sale, import, certification, and publication licenses in the fields of pharmaceuticals and cosmetics; charges for appraisal of standards and conditions for practice and business relating to pharmaceuticals and cosmetics.

2. This Circular applies to charge payers; charge collectors; other organizations and individuals involved in the collection, remittance, management and use of the charges relating to pharmaceuticals and cosmetics.

Article 2. Charge payers

Charge payers are organizations and individuals who submit dossiers to request state management agencies to perform tasks relating to pharmaceuticals and cosmetics specified in the Charge Tariff attached to this Circular.

Article 3. Charge collectors

Charge collectors are the Ministry of Health or units under the Ministry of Health that are assigned by the Ministry of Health to perform specified tasks of collecting the charges defined in the Charge Tariff issued together with this Circular; and Departments of Health of provinces and centrally-run cities performing specified tasks of collecting the charges defined in the Charge Tariff to this Circular.

Article 4. Charge rates

Charge rates relating to pharmaceuticals and cosmetics shall comply with the Charge Tariff issued together with this Circular.

Article 5. Declaration, payment of charges

1. Charge payers shall pay charges at the rates specified in Article 4 of this Circular to the charge collectors in the form specified in the Minister of Finance’s Circular No. 74/2022/TT-BTC dated December 22, 2022, providing for forms and time limits for the collection, payment and declaration of charges and fees falling under the Ministry of Finance’s competence.

2. By the 5th of every week, charge collectors shall deposit the charge amount collected in the previous week into charge collectors’ accounts of charge amount pending remittance into the state budget that are opened at the State Treasury. The charge collectors shall declare, collect, remit the collected charge amount and make a finalization of such collected charge amount in accordance with Circular No. 74/2022/TT-BTC (charge amount collected by central agencies shall be remitted into the central budget, charge amount collected by local agencies shall be remitted into the local budget).

Article 6. Management and use of charge amount

1. Charge collectors shall remit the entire collected charge amount into the state budget. Funding for the performance of the tasks and the collection of charges shall be allocated by the state budget in the charge collectors' estimates according to the state budget expenditure regime and norms.

2. In case charge collectors are state agencies allowed to have their operating expenses covered by charge revenues as specified in Clause 1 Article 4 of the Government’s Decree No. 120/2016/ND-CP of August 23, 2016, on detailing and guiding the implementation of a number of articles of the Law on Charges and Fees, they may retain 70% of collected charge amount for covering expenditure contents specified in Article 5 of Decree No. 120/2016/ND-CP; and remit 30% of the collected amount into the state budget according to chapters and sub-sections of the current State Budget Index.

Article 7. Implementation provisions

1. This Circular takes effect on August 01, 2023.

2. This Circular replaces the Minister of Finance’s Circular No. 277/2016/TT-BTC dated November 14, 2016, prescribing the rates, collection, remittance, management and use of the charges relating to pharmaceuticals and cosmetics; the Minister of Finance’s Circular No. 114/2017/TT-BTC dated October 24, 2017, amending and supplementing the Charge Tariff in the fields of pharmaceuticals and cosmetics promulgated together with the Circular No. 277/2016/TT-BTC dated November 14, 2016, prescribing the rates, collection, remittance, management and use of the charges relating to pharmaceuticals and cosmetics.

3. Other contents relating to the collection, remittance, management, use, collection documents and publicization of the collection regime of charges relating to pharmaceuticals and cosmetics that are not specified in this Circular shall comply with the following documents: Law on Charges and Fees; Law on Tax Administration; Decree No. 120/2016/ND-CP; Government’s Decree No. 126/2020/ND-CP dated October 19, 2020, detailing a number of articles of the Law on Tax Administration; Government’s Decree No. 91/2022/ND-CP dated October 30, 2022, on amending and supplementing a number of articles of Decree No. 126/2020/ND-CP; Government’s Decree No. 11/2020/ND-CP dated January 20, 2020, providing for administrative procedures in the field of state treasury; Government’s Decree No. 123/2020/ND-CP dated October 19, 2020, on invoices and documents; and the Minister of Finance’s Circular No. 78/2021/TT-BTC dated September 17, 2021, guiding the implementation of a number of articles of the Law on Tax Administration dated June 13, 2019, and the Government’s Decree No. 123/2020/ND-CP dated October 19, 2020, on invoices and documents.

4. During the implementation, if the relevant documents mentioned herein are amended, supplemented or replaced, these amending, supplementing or replacing ones shall prevail.

5. Any problems arising in the course of implementation should be promptly reported to the Ministry of Finance for consideration and guidance./.

 

 

FOR THE MINISTER

THE DEPUTY MINISTER

 

 

Cao Anh Tuan

 

THE TARIFF OF CHARGES RELATING TO PHARMACEUTICALS AND COSMETICS

(Promulgated together with the Minister of Finance’s Circular
No. 41/2023/TT-BTC dated June 12, 2023)

_____________________

 

No.

Charge

Unit

Rate

(VND 1,000)

I

Charges for appraisal for grant of licenses of free sale, import, certification, and publication in the fields of pharmaceuticals and cosmetics

 

 

1

Appraisal for certification of information and advertisement of drugs, cosmetics

Dossier

1,600

2

Appraisal for grant of registration certificates of free sale for drugs and drug materials

 

 

a

Appraisal for grant of registration certificates of free sale for drugs (except for traditional medicaments specified at Point b of this Section)

Dossier

11,000

b

Appraisal for grant of registration certificates of free sale for drug materials, traditional medicaments

Dossier

5,500

c

Appraisal for extension of registration certificates of free sale for drugs, drug materials, traditional medicaments

Dossier

4,500

d

Appraisal for modification/supplementation of registration certificates of free sale for drugs, drug materials, traditional medicaments

Dossier

1,500

3

Appraisal for grant of import licenses of drugs that do not have registration certificates of free sale for drugs in Vietnam (except for import cases specified in Articles 67, 72, 73, 74, 75 of the Government’s Decree No. 54/2017/ND-CP dated May 8, 2017, detailing a number of articles of and providing measures for implementing the Pharmacy Law)

Item

1,200

4

Appraisal for publication of cosmetic products, publication of standards and quality of medicinal materials

Dossier

500

II

Charges for appraisal of standards and conditions for practice and business relating to pharmaceuticals and cosmetics

 

 

1

Appraisal of cosmetic manufacturing conditions to grant certificates of ASEAN cosmetic good manufacturing practices (CGMP - ASEAN)

Facility

30,000

2

Appraisal of conditions and assessment of satisfying the good practices of manufacturing of drugs, drug materials, medicinal materials, traditional medicaments (GMP) (assessment of satisfaction, assessment of maintenance, assessment of control of changes at the facility)

Facility

30,000

3

Appraisal of conditions and assessment of satisfying the good practices of manufacturing of pharmaceutical package at the facility

Facility

30,000

4

Appraisal of conditions and assessment of satisfying the good practices of storage of drugs, drug materials, medicinal materials, traditional medicaments (GSP) (assessment of satisfaction, assessment of maintenance, assessment of control of changes at the facility)

Facility

21,000

5

Appraisal of conditions and assessment of satisfying the good laboratory practices (GLP) (assessment of satisfaction, assessment of maintenance, assessment of control of changes at the facility)

Facility

21,000

6

Appraisal of conditions and assessment of satisfying the good practices of distribution of drugs for establishments wholesaling drugs (GDP) (assessment of satisfaction, assessment of maintenance, assessment of control of changes at the facility)

Facility

4,000

7

Appraisal of dossiers for grant of pharmacy practice certificates to grant, re-grant, modify pharmacy practice certificates

Dossier

500

8

Appraisal of conditions and assessment of satisfying the good pharmacy practices (GPP) (assessment of satisfaction, assessment of maintenance, assessment of control of changes at the facility)

 

 

a

For facilities located in areas with difficult and extremely difficult socio-economic conditions as prescribed in the Government’s Decree No. 31/2021/ND-CP dated March 26, 2021, detailing and guiding the implementation of a number of articles of the Law on Investment

Facility

500

b

For facilities located in remaining areas

Facility

1,000

9

Appraisal of publication of declared drug prices; re-declared drug prices

Dossier

800

10

Appraisal of cosmetic manufacturing conditions for grant of certificates of eligibility for cosmetic manufacturing

Facility

6,000

11

Appraisal of conditions of facilities retailing medicinal materials, drugs from medicinal materials or traditional drugs (including traditional medicaments)

 

 

a

For facilities located in areas with difficult and extremely difficult socio-economic conditions as prescribed in the Decree No. 31/2021/ND-CP

Facility

300

b

For facilities located in remaining areas

Facility

750

12

Assessment of satisfying the good agricultural and collection practices and principles and standards for exploitation of natural medicinal materials satisfiable to good agricultural and collection practices (GACP) (except for cases being supported with charges prescribed in Clause 2 Article 6 of the Government’s Decree No. 65/2017/ND-CP dated May 19, 2017, providing specific policies on seeds, funding and technology for culturing and exploitation of medicinal materials)

Dossier

9,000

13

Appraisal, assessment of satisfying the good manufacturing practices (GMP) for drugs, drug materials overseas upon registration for free sale in Vietnam

 

 

a

Appraisal of dossiers

Dossier

2,250

b

Appraisal and actual assessment at the facilities (excluding travel expenses: travel, accommodation allowances, meals and others, insurance premiums as prescribed)

Facility

200

14

Appraisal for grant of certificates of free sale of cosmetics (CFS)

Item

500

15

Appraisal and assessment of satisfying conditions for drug bioequivalence testing facility (first assessment, assessment of maintenance, assessment of control of changes at the facility)

Facility

21,000

16

Appraisal of dossiers of request for first assessment, assessment of maintenance of satisfying the good practices of clinical trial of drugs

Dossier

30,000

 

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