No.

Description

Unit

Amount (VND 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, cosmetics to be advertised

Application

1.800

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.)

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 issue CGMP certificate in conformity with CGMP - ASEAN

Facility

20.000

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

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

b

Regarding bioequivalence drugs

Application

2.500

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 accordance with decision of the Minister of Health

Application

1.000

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, remote and isolated provinces

Facility

200

15

Assessment of good agricultural and collection practices (GACP)

Application

6.000