Announcement of fees in the field of pharmaceuticals and cosmetics as of August 1, 2023 in Vietnam

No

Content

Unit

Fee
(1,000 VND)

I

Fees for appraisal, licensing, circulation, import, confirmation, and announcement in the field of pharmaceuticals and cosmetics

1

Appraisal and confirmation of information content and advertising of drugs and cosmetics

File

1,600

2

Appraisal and issuance of circulation registration certificates for drugs and medicinal ingredients

a

Appraisal and issuance of drug circulation registration certificate (except for traditional drugs specified in Point b of this Section)

File

11,000

b

Appraisal and issuance of registration certificates for circulation of medicinal ingredients and traditional medicines

File

5,500

c

Appraisal of renewal of circulation registration papers for drugs, medicinal ingredients, and traditional medicines

File

4,500

d

Appraisal of changes/additions to circulation registration papers for drugs, medicinal ingredients, and traditional medicinal herbs

File

1,500

3

Appraisal and issuance of import licenses for drugs that do not have drug circulation registration certificates in Vietnam (except for cases of import as prescribed in Articles 67, 72, 73, 74, 75 of  Decree No. 54/2017/ND- CP  dated May 8, 2017 of the Government detailing a number of articles and measures to implement the Pharmacy Law)

Items

1,200

4

Appraisal and announcement of cosmetic products, announcement of standards and quality of medicinal herbs

File

500

II

Fees for appraisal of standards and conditions for practice and business in the field of pharmaceuticals and cosmetics

1

Evaluateing cosmetic production conditions and issue a certificate that the facility meets CGMP - ASEAN standards

Basis

30,000

2

Appraisal of conditions and assessment of compliance with good manufacturing practices for drugs, medicinal ingredients, medicinal materials, and traditional medicinal herbs (GMP) (assessment of response, assessment of maintenance, assessment of change control at the facility) department)

Basis

30,000

3

Evaluating conditions and assess compliance with good pharmaceutical packaging production practices at the facility

Basis

30,000

4

Appraisal of conditions and assessment of compliance with good storage practices for drugs, medicinal ingredients, medicinal materials, and traditional medicinal herbs (GSP) (assessment of response, assessment of maintenance, assessment of change control at the facility) department)

Basis

21,000

5

Validating conditions and assess compliance with good laboratory practice (GLP) (assessment of response, assessment of maintenance, assessment of change control at the facility)

Basis

21,000

6

Appraisal of conditions and assessment of compliance with good drug distribution practices for wholesale establishments (GDP) (assessment of response, assessment of maintenance, assessment of change control at the facility)

Basis

4,000

7

Appraisal of application for pharmacy practice certificate: Issuance, re-issuance, adjustment of pharmacy practice certificate content

File

500

8

Appraisal of conditions and assessment of compliance with good retail practice (GPP) (assessment of response, assessment of maintenance, assessment of change control at the facility)

a

For establishments in areas with difficult and extremely difficult socio-economic conditions according to the provisions of Decree No. 31/2021/ND-CP  dated March 26, 2021 of the Government detailing regulations and guide the implementation of a number of articles of the Investment Law

Basis

500

b

For establishments in remaining areas

Basis

1,000

9

Appraisal and announcement of declared and re-declared drug prices

File

800

10

Appraisal of cosmetic production conditions and issuance of certificate of eligibility for cosmetic production

Basis

6,000

11

Appraisal of conditions of establishments specializing in retailing medicinal herbs, herbal medicines, and traditional medicines (including traditional medicines)

a

For establishments in areas with difficult and extremely difficult socio-economic conditions as prescribed in Decree No. 31/2021/ND-CP

Basis

300

b

For establishments in remaining areas

Basis

750

12

Evaluate compliance with good practices in growing and harvesting medicinal herbs and principles of standards for exploiting natural medicinal herbs that meet GACP (except for cases where fees are supported as prescribed in Clause 2, Article 6 of Decree No.  65/2017/ND-CP  dated May 19, 2017 of the Government stipulating specific policies on varieties, capital and technology in the development of aquaculture and exploitation of medicinal materials)

File

9,000

13

Appraisal and assessment of compliance with good practice (GMP) for manufacturing drugs and medicinal ingredients abroad when registering for circulation in Vietnam

a

Document appraisal

File

2,250

b

On-site appraisal and assessment (excluding per diem expenses: Travel, accommodation allowances, meals and pocket money, insurance of all kinds as prescribed)

Basis

200

14

Appraisal and issuance of certificate of free circulation of cosmetics (CFS)

Items

500

15

Appraisal and assessment of meeting the conditions of the drug bioequivalence testing facility (initial evaluation, maintenance evaluation, evaluation of change control at the facility)

Basis

21,000

16

Appraisal of dossiers requesting initial assessment and maintenance assessment to meet good clinical drug testing practices

File

30,000