THE MINISTRY OFFINANCE ---SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness CIRCULAR ON AMOUNTS, COLLECTION, PAYMENT, MANAGEMENT AND USE OF FEES IN THE FIELDS OF PHARM
Trang 1THE MINISTRY OF
FINANCE
-SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness
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
Trang 2Article 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
Trang 3Vu 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)
1,000)
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,
2 Assessment for marketing authorization for drugs, medicinal materials
2.1 Assessment for marketing authorization for drugs, medicinal materials with regard to new registration and
re-registration
Application 5.500
2.2 Assessment for marketing authorization for drugs, medicinal materials with regard to registration renewal Application 3.000
2.3
Assessment for marketing authorization with regard to
application for registration of change of drugs, medicinal
materials obtaining marketing authorization (minor or
major changes (including minor changes need to be
approved and changes according to forms of
notification))
Application 1.000
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,
non-commercial drugs, drugs used as registration samples or
testing samples, drugs for clinical trials, bioequivalence
testing, etc.)
4 Assessment for import licenses for herbal ingredients,
5 Assessment for declaration of cosmetics, declaration of
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
Trang 4issue 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
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
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
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
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
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)
Application 1.500
c Regarding drug production facilities satisfying GMP-PIC/s and GMP-EU Application 450
d Fee for consideration of list of bidders meeting
requirements for qualification and credibility in bidding
of herbal ingredients, traditional ingredients in
Application 1.000
Trang 5accordance with decision of the Minister of Health
12 Assessment of application for cards of pharmaceutical sales representative Application 200
13 Assessment of cosmetic good manufacturing practice to issue certificate of eligibility for cosmetic production Facility 6.000
14
Assessment of standards for practice in business facilities
of herbal ingredients, herbal ingredient drugs, traditional
drugs (including traditional ingredients):
a Regarding medicine-trading facilities in provinces and
central-affiliated cities; midland provinces Facility 500
b Regarding medicine-trading facilities in mountainous,
15 Assessment of good agricultural and collection practices
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