On June 12, 2023, the Ministry of Finance
promulagated Circular No.41/2023/TT-BTC the
rates, collection, transfer and use of fees in the fields of pharmacy and
cosmetics. Specifically:
Fees for assessment of applications for marketing
authorization, import, certification, declaration in the field of pharmacy,
cosmetics from 500.000 VND to 11.000.000 VND. In which:
-
Assessment and certification of information,
advertisements about drugs, cosmetics: 1.600.000 VND/application.
-
Assessment for marketing authorization for drugs
(except traditional ingredients specified in Point b of this Section):
11.000.000 VND/application.
-
Assessment for marketing authorization for
medicinal materials, traditional ingredients: 5.500.000 VND/application.
-
Assessment for licensing import of drugs without
marketing authorization in Vietnam: 1.200.000 VND/item.
- Assessment
for declaration of cosmetics, declaration of herbal ingredient standards:
500.000 VND/application.
Fees for assessment of competency and eligibility for
practice and trading in pharmacy, cosmetics from 200.000 VND to 30.000.000 VND.
Some specific fees are as follows:
- Assessment of eligibility for production of cosmetics and
issuance of certificate of conformity with CGMP – ASEAN: 30.000.000
VND/facility
- Assessment of
GMP conformity for herbal ingredients and traditional ingredients (assessment
of conformity, maintenance, control of changes at the facility): 30.000.000
VND/facility.
- Assessment of application for pharmaceutical practice
certificate: issuance, re-issuance, revision of the pharmaceutical practice
certificate: 500.000 VND/application.
- Assessment of GMP conformity for pharmaceutical packaging
at the facility: 30.000.000 VND/facility.
Collecting organizations
shall fully transfer the collected fees to state budget.
In case the collecting organization is a state agency that is
permitted to use the collected fees 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.
For details: 
ND41/2023.doc
Department of Enterprise Management.