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THE MINISTRY OF FINANCE OF VIETNAM
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SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
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No. 41/2023/TT-BTC
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Hanoi, June 12, 2023
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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 MINISTER
DEPUTY MINISTER
Cao 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