CIRCULAR NO 2772016TT BTC DATED NOVEMBER 14, 2016, ON AMOUNTS, COLLECTION, PAYMENT, MANAGEMENT AND USE OF FEES IN THE FIELDS OF PHARMACY AND COSMETICS 277 2016 TT BTC 335308

THE MINISTRY OF
FINANCE
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SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No. 277/2016/TT-BTC

Hanoi, November 14, 2016

CIRCULAR
ON AMOUNTS, COLLECTION, PAYMENT, MANAGEMENT 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 Government’s Decree No. 120/2016/ND-CP dated August 23, 2016 on guidelines
for the Law on fees and charges;
Pursuant to the Government's Decree No. 215/2013/ND-CP dated December 23, 2013 defining the
functions, tasks, entitlements and organizational structure of the Ministry of Finance;
At the request of the Director of the Tax Policy Department,
The Minister of Finance promulgates a Circular on amounts, collection, payment, management and
use of fees in the fields of pharmacy and cosmetics.
Article 1. Scope and regulated entities
1. This Circular deals with amounts, collection, payment, management and use of fees in the fields
of pharmacy and cosmetics.
2. This Circular applies to payers and collecting authorities of fees in the field of pharmacy and
cosmetics and other entities in connection with the collection, payment, management and use of
fees in the fields of pharmacy and cosmetics.
Article 2. Payers

Any entity applying to competent authorities for assessment in the field of pharmacy or cosmetics
as prescribed in the Schedule issued herewith shall pay a given amount of fee as prescribed.
Article 3. Collecting authorities
Drug administration of Vietnam, Traditional Medicine Administration of Vietnam (affiliated to the
Ministry of Health) and Services of Health of provinces and central-affiliated cities that are in
charge of tasks prescribed in the Schedule hereof shall be the collecting authorities.
Article 4. Amount
Amounts of fees in the fields of pharmacy and cosmetics shall be specified in the Schedule issued
herewith.


Article 5. Statement and payment
1. No later than every Thursday, the collecting authority shall deposit the amount of fees collected
of the last week to the account of fees pending payment to State budget opened at a State Treasury.
2. The collecting authority shall make monthly and annual statements and pay fees as prescribed in
Clause 3 Article 19 and Clause 2 Article 26 of Circular No. 156/2013/TT-BTC dated November 6,
2013 of the Minister of Finance on guidelines for the Law on Tax administration; Law on
amendments to the Law on Tax administration and the Decree No. 83/2013/ND-CP dated July 22,
2013 of the Government.
Article 6. Management and use of fees
1. Each collecting authority shall pay full amount of fees collected to State budget. Expenses
associated with assessment and collection of fees shall be covered as specified in the collecting
agency’s estimates according to regime and limits of State budget expenditures in accordance with
regulations of law.
2. Eligible collecting authorities prescribed in Clause 1 of Article 4 of the Government's Decree No.
120/2016/ND-CP dated August 23, 2016 may keep 30% of the amount of fees collected to cover
expenses prescribed in Article 5 of the Government's Decree No. 120/2016/ND-CP dated August
23, 2016. 30% of fees collected shall be paid to State budget according to the applicable State
budget entries.
Article 7. Implementation

1. This Circular comes into force from January 1, 2017 and replaces regulations on collection of
fees in the field of pharmacy and cosmetics prescribed in Circular No. 03/2013/TT-BYT dated
January 8, 2013 of the Minister of Finance on assessment fees for conditional trading; assessment
fees for criteria and conditions for medical and/or pharmacy practice; fees for licenses for
export/import of medical equipment, medicinal products, medical practice certificates, health
facility operation license.
2. If other contents in connection with collection, payment, management, and use of fees, receipt
documents and fee collection regime are not guided in this Circular, they shall apply responsive
guidelines in the Law on fees and charges, Decree No. 120/2016/ND-CP dated August 23, 2016 on
guidelines for the Law on fees and charges; Circular No. 156/2013/TT-BTC dated November 6,
2013 of the Minister of; and Circular of the Minister of Finance on printing, issuance, management
and use of documents of collection of fees and charges payable to State budget and their amending
documents (if any).
3. Difficulties that arise during the implementation must be reported to the Ministry of Finance for
consideration./.

PP. MINISTER
DEPUTY MINISTER


Vu Thi Mai

SCHEDULE OF AMOUNTS OF FEES IN THE FIELDS OF PHARMACY AND
COSMETICS
(Issued together with Circular No. 277/2016/TT-BTC dated November 14, 2016 of the Ministry of
Finance)

No.

Description

Unit

I

Assessment fees for issuance of licenses for marketing,
import, certification, declaration in the field of
pharmacy, cosmetics

1

Assessment and certification of information about drugs,
Application
cosmetics to be advertised

2

Assessment for marketing authorization for drugs,
medicinal materials

Amount
(VND
1,000)

1.800

Assessment for marketing authorization for drugs,
2.1 medicinal materials with regard to new registration and
re-registration

Application

5.500

Assessment for marketing authorization for drugs,
medicinal materials with regard to registration renewal

Application

3.000

Assessment for marketing authorization with regard to
application for registration of change of drugs, medicinal
materials obtaining marketing authorization (minor or
2.3
Application
major changes (including minor changes need to be
approved and changes according to forms of
notification))

1.000

2.2

3

Assessment for import licenses for commercial drugs
with no registration number (other than import of rare
drugs, drugs for the special treatment needs, drugs for
prevention and combating of epidemic and natural

disasters, drugs for medication assistance, noncommercial drugs, drugs used as registration samples or
testing samples, drugs for clinical trials, bioequivalence
testing, etc.)

Item

800

4

Assessment for import licenses for herbal ingredients,
traditional ingredients

Item

200

5

Assessment for declaration of cosmetics, declaration of
herbal ingredient standard

Item

500

II

Assessment fees for criteria and conditions for
practice and trading in pharmacy, cosmetics

1

Assessment of cosmetic good manufacturing practice to

Facility

20.000


issue CGMP certificate in conformity with CGMP ASEAN
2

Assessment of good manufacturing practice for drugs
and herbal ingredients (GMP)

Facility

20.000

3

Assessment of good manufacturing practice for
pharmaceutical packaging

Facility

20.000

4

Assessment of good storage practice for drugs and herbal
ingredients (GSP)

Facility

14.000

5

Assessment of good laboratory practice for drugs

Facility

14.000

6

Assessment of good manufacturing practice for
traditional medicines, herbal ingredient drugs, herbal
ingredients according to road map initiation of GMP

Facility

6.000

7

Assessment of good distribution practice for wholesale
facilities (GDP)

Facility

4.000

8

Assessment of application of pharmaceutical practice
certificate

Application

500

9

Assessment of good pharmacy practice (GPP) or
standard for pharmaceutical practice with regard to
pharmacies not compulsory to conform to good
pharmacy practice according to the road map

Facility

1.000

10

Assessment of good pharmacy practice (GPP) for
pharmacies in disadvantaged, mountainous, and island
areas

Facility

500

11

Assessment of declaration of drug prices:

11.1 For declaration or re-declaration

Application

100

11.2 For declaration of lists serving bidding:

Application

a

b
c
d

Regarding proprietary medicines; list of drugs produced
at the production facilities that satisfy WHO/GMP
standards and obtain certificates of the Ministry of Health
of Vietnam and obtain marketing authorizations from
regulatory authorities of state members of ICH

(International Council for Harmonization of Technical
Application
Requirements for Pharmaceuticals for Human Use); list
of drugs produced from materials (active ingredients)
produced in state members of ICH and Australia; list of
drugs produced from materials (active ingredients)
obtaining CEP (Certificate of Suitability to the
Monographs of the European Pharmacopoeia)
Regarding bioequivalence drugs
Regarding drug production facilities satisfying GMPPIC/s and GMP-EU

1.500

Application

2.500

Application

450

Fee for consideration of list of bidders meeting
Application
requirements for qualification and credibility in bidding
of herbal ingredients, traditional ingredients in

1.000


accordance with decision of the Minister of Health

12

Assessment of application for cards of pharmaceutical
sales representative

13

Assessment of cosmetic good manufacturing practice to
issue certificate of eligibility for cosmetic production

14

Assessment of standards for practice in business facilities
of herbal ingredients, herbal ingredient drugs, traditional
drugs (including traditional ingredients):

a

Application

200

Facility

6.000

Regarding medicine-trading facilities in provinces and
central-affiliated cities; midland provinces

Facility

500

b

Regarding medicine-trading facilities in mountainous,
remote and isolated provinces

Facility

200

15

Assessment of good agricultural and collection practices
Application
(GACP)

6.000

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