Management and Use of Fees in the Fields of Pharmaceuticals and Cosmetics in Vietnam

According to the Circular, the appraisal fees for issuing circulation permits, import permits, confirmations, and declarations in Vietnam include:

+ Appraisal fee for confirmation of drug and cosmetic information, advertisement content: 1,800,000 VND/document;

+ Appraisal fee for issuing circulation permits for drugs and drug ingredients for initial registration and re-registration: 5,500,000 VND/document;

+ Appraisal fee for issuing circulation permits for registration documents for changes/supplements of drugs and drug ingredients with existing circulation permits (major changes, minor changes (including minor changes needing approval and changes by notification)): 1,000,000 VND/document;

The appraisal fees for standards and conditions of practice, business in the field of pharmaceuticals, cosmetics in Vietnam include:

+ Appraisal fee for standards and conditions for drug and herb production (GMP): 20,000,000 VND/facility;

+ Appraisal fee for standards and conditions for pharmaceutical packaging production: 20,000,000 VND/facility;

+ Appraisal fee for documents for issuing pharmaceutical practice certificates: 500,000 VND/document;

+ Appraisal fee for documents for issuing drug introducer cards: 200,000 VND/document;

+ Appraisal fee for conditions for cosmetic production to issue Certificates of eligibility for cosmetic production: 6,000,000 VND/facility.

The Circular stipulates that by the latest on the fifth day of every week, the fee-collecting organization must transfer the collected fees from the previous week into the pending fee account at the State Treasury and declare the collection and payment of fees according to Clause 3 Article 19, Clause 2 Article 26 Circular 156/2013/TT-BTC and Decree 83/2013/ND-CP.

Circular 277/2016/TT-BTC is effective from January 01, 2017, and replaces the provisions related to fee collection in the pharmaceutical and cosmetic fields as stipulated in Circular 03/2013/TT-BYT.

Source: Finance Magazine

>> CLICK HERE TO READ THIS ARTICLE IN VIETNAMESE