What is the current appraisal fee for cosmetic product registration in Vietnam?

13:44, 11/07/2024

On October 24, 2017, the Ministry of Finance promulgated Circular 114/2017/TT-BTC amending and supplementing the Fee Schedule in the field of pharmaceuticals and cosmetics issued together with Circular 277/2016/TT-BTC.

Circular 114 has reduced the appraisal fees for confirming the content of drug and cosmetic information and advertisements, while also abolishing the appraisal fees for issuing import permits for medicinal materials and traditional medicine. To be specific: the new appraisal fee rates are as follows:

No.	Types of fees	Unit	Fee amount (1,000 VND)
I	Appraisal fees for licensing the circulation, importation, confirmation, and declaration in the pharmaceutical and cosmetic fields
1	Appraisal for confirming the content of drug and cosmetic information and advertisements	Dossier	1,600
2	Appraisal for licensing the circulation of drugs and drug materials
2.1	Appraisal for licensing the circulation of drugs and drug materials for first-time registration, re-registration	Dossier	5,500
2.2	Appraisal for licensing the circulation of drugs and drug materials for registration extension	Dossier	3,000
2.3	Appraisal for licensing the circulation for the dossiers of registration for changes/supplementation of drugs, and drug materials with existing circulation licenses (major changes, minor changes (including minor changes requiring approval and changes notified))	Dossier	1,000
3	Appraisal for issuing import permits for finished drugs without registration numbers (except for the importation of rare drugs, drugs for special treatment needs, epidemic and natural disaster prevention drugs, drugs for health programs, aid drugs, non-trade drugs, drugs for registration sample, testing sample, clinical trial, bioequivalence trial, etc.)	Item	800
4	Appraisal for declaring cosmetic products, declaring medicinal material standards	Item	500

More details can be found in Circular 114/2017/TT-BTC effective from December 11, 2017.

- Thanh Lam -

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