| Số hiệu | 41/2023/TT-BTC |
| Loại văn bản | Thông tư |
| Cơ quan | Bộ Tài chính |
| Ngày ban hành | 12/06/2023 |
| Người ký | Cao Anh Tuấn |
| Ngày hiệu lực | |
| Tình trạng |
|
THE MINISTRY OF FINANCE OF VIETNAM |
SOCIALIST REPUBLIC OF VIETNAM |
|
No. 41/2023/TT-BTC |
Hanoi, June 12, 2023 |
CIRCULAR
RATES, COLLECTION, TRANSFER AND USE OF FEES IN THE FIELDS OF PHARMACY AND COSMETICS
Pursuant to the Law on Fees and Charges dated November 25, 2015;
Pursuant to the Law on State Budget dated June 25, 2015;
Pursuant to the Law on Pharmacy dated April 06, 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 elaborating some Articles of the Law on Fees and Charges;
Pursuant to the Government's Decree No. 54/2017/ND-CP dated May 08, 2017 on elaboration of the Law on Pharmacy;
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Pursuant to the Government’s Decree No. 14/2023/ND-CP dated April 20, 2023 on functions, tasks, powers and organizational structure of the Ministry of Finance;
At request of the Director of the Tax Policy Department;
The Minister of Finance promulgates a Circular on rates, collection, transfer and use of fees in the fields of pharmacy and cosmetics.
Article 1. Scope of application and regulated entities
1. This Circular provides for the rates, collection, transfer and use of fees in the fields of pharmacy and cosmetics, including: Fees for marketing authorization, import, certification, declaration in the fields of pharmacy and cosmetics; fees for assessment of competency, eligibility for practice and trading in the fields of pharmacy and cosmetics.
2. This Circular applies to fee payers, collecting organizations, other organizations and individuals that are relevant to the collection, transfer and use of fees in the fields of pharmacy and cosmetics.
Article 2. Fee payers
Fee payers are organizations and individuals that submit applications requesting regulatory authorities to perform certain tasks in the field of pharmacy and cosmetics specified in the Fee Schedule enclosed to this Circular.
Article 3. Collecting organizations
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Article 4. Fee rates
Fee rates in the field of pharmacy and cosmetics are specified in the Fee Schedule enclosed to this Circular.
Article 5. Declaring and paying fees
1. Fee payers shall pay the fees according to the rates mentioned in Article 4 of this Circular to the collecting organizations using the methods specified in Circular No. 74/2022/TT-BTC dated December 22, 2022 of the Minister of Finance on methods, deadlines for collection, transfer and declaration of fees and charges under the jurisdiction of the Ministry of Finance.
2. By every Thursday, collecting organizations shall transfer the fees that were collected in the previous week to their accounts designated for amounts pending transfer to state budget opened at State Treasury. Collecting organizations shall declare, collect, transfer and finalize fees in accordance with Circular No. 74/2022/TT-BTC (fees collected by central authorities shall be transferred to the central government budget; fees collected by local authorities shall be transferred to local government budgets).
Article 6. Management and use of fees
1. Collecting organizations shall fully transfer the collected fees to state budget. The cost of operation and fee collection shall be covered by the state budget within the cost estimate of the collecting organization and state budget norms.
2. In case the collecting organization is a state agency that is permitted to use its revenue to cover its operating costs according to Clause 1 Article 4 of the Government’s Decree No. 120/2016/ND-CP dated August 23, 2016, it may retain 70% of the collected fees to cover the costs specified in Article 5 of Decree No. 120/2016/ND-CP and transfer the remaining 30% to state budget in accordance with applicable state budget laws.
Article 7. Implementation
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2. This Circular replaces Circular No. 277/2016/TT-BTC dated November 14, 2016 of the Minister of Finance on rates, collection, transfer and use of fees in the fields of pharmacy and cosmetics, and Circular No. 114/2017/TT-BTC dated October 24, 2017 amending the Fee Schedule enclosed with Circular No. 277/2016/TT-BTC.
3. Other contents relevant to fee collection, transfer, management, use, receipt vouchers, disclosure of collection regulations in the field of pharmacy and cosmetics that are not mentioned in this Circular shall comply with the following documents: the Law and Fees and Charges, Decree No. 120/2016/ND-CP; Decree No. 126/2020/ND-CP; Decree No. 91/2022/ND-CP; Decree No. 11/2020/ND-CP; Decree No. 123/2020/ND-CP; Circular No. 78/2021/TT-BTC and Decree No. 123/2020/ND-CP.
4. In case any document referred to in this Circular is amended or replaced during the implementation of this Circular, the newest document shall apply.
5. Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Finance for consideration and guidance./.
PP MINISTERDEPUTY MINISTERCao Anh Tuan
FEE SCHEDULE IN THE FIELD OF PHARMACY AND COSMETICS
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No.
Description
Unit
Rate
(1.000 VND)
I
Fees for assessment of applications for marketing authorization, import, certification, declaration in the field of pharmacy, cosmetics
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Assessment and certification of information, advertisements about drugs, cosmetics
Application
1.600
2
Assessment for marketing authorization for drugs, medicinal materials
a
Assessment for marketing authorization for drugs (except traditional ingredients specified in Point b of this Section)
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11.000
b
Assessment for marketing authorization for medicinal materials, traditional ingredients
Application
5.500
c
Assessment for renewal of marketing authorization for medicinal materials, traditional ingredients
Application
4.500
...
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...
Assessment for changes/supplementation of marketing authorization for medicinal materials, traditional ingredients
Application
1.500
3
Assessment for licensing import of drugs without marketing authorization in Vietnam (except the cases of import specified in Articles 67, 72, 73, 74, 75 of the Government's Decree No. 54/2017/ND-CP dated May 08, 2017 on elaboration of the Law on Pharmacy)
Item
1.200
4
Assessment for declaration of cosmetics, declaration of herbal ingredient standards
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500
II
Fees for assessment of competency and eligibility for practice and trading in pharmacy, cosmetics
1
Assessment of eligibility for production of cosmetics and issuance of certificate of conformity with CGMP - ASEAN
Facility
30.000
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Assessment of GMP conformity for herbal ingredients and traditional ingredients (assessment of conformity, maintenance, control of changes at the facility)
Facility
30.000
3
Assessment of GMP conformity for pharmaceutical packaging at the facility
Facility
30.000
4
Assessment of Good Storage Practice (GSP) conformity for drugs, medicinal ingredients, herbal ingredients and traditional ingredients (assessment of conformity, maintenance, control of changes at the facility)
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21.000
5
Assessment of Good Laboratory Practice (GLP) (assessment of conformity, maintenance, control of changes at the facility)
Facility
21.000
6
Assessment of Good Distribution Practice (GDP) of wholesalers (assessment of conformity, maintenance, control of changes at the facility)
Facility
4.000
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Assessment of application for pharmaceutical practice certificate: issuance, re-issuance, revision of the pharmaceutical practice certificate
Application
500
8
a
For facilities in disadvantaged and extremely disadvantaged areas according to the Government’s Decree No. 31/2021/ND-CP
Facility
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b
For facilities in other areas
Facility
1.000
9
Assessment of declared and re-declared drug prices
Application
800
10
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Facility
6.000
11
Assessment of eligibility for retailing of herbal ingredients, herbal drugs, traditional drugs (including traditional ingredients)
a
For facilities in disadvantaged and extremely disadvantaged areas according to the Government’s Decree No. 31/2021/ND-CP
Facility
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b
For facilities in other areas
Facility
750
12
Assessment of Good Agricultural and Collection Practice (GACP) conformity (in case of eligibility for fee support according to 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 production and use of herbal ingredients)
Application
9.000
13
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a
Application assessment
Application
2.250
b
On-assessment (not including the costs of travel, lodging, meals, allowances, insurance premiums)
Facility
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14
Assessment for issuance of the Certificate of Free Sale (CFS) for cosmetics
Item
500
15
Assessment of eligibility of bioequivalence testing laboratory (first assessment, maintenance, control of changes at the facility)
Facility
21.000
16
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Application
30.000
| Số hiệu | 41/2023/TT-BTC |
| Loại văn bản | Thông tư |
| Cơ quan | Bộ Tài chính |
| Ngày ban hành | 12/06/2023 |
| Người ký | Cao Anh Tuấn |
| Ngày hiệu lực | |
| Tình trạng |
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| Số hiệu | 41/2023/TT-BTC |
| Loại văn bản | Thông tư |
| Cơ quan | Bộ Tài chính |
| Ngày ban hành | 12/06/2023 |
| Người ký | Cao Anh Tuấn |
| Ngày hiệu lực | |
| Tình trạng |