Appraisal of Drug and Cosmetic Advertisements with a Fee of 1.8 Million VND per Dossier

The Circular stipulates that organizations and individuals, when performing tasks related to the fields of pharmaceuticals and cosmetics as specified by state management agencies, must pay fees. The Drug Administration of Vietnam; the Agency of Traditional Medicine Administration (Ministry of Health) and the Departments of Health of provinces and cities directly under the central government shall perform the tasks prescribed for fee collection as the fee-collecting organizations.

The Circular clearly states the fee levels for assessing the licensing of marketing authorization, import authorization, confirmation, and publication in the fields of pharmaceuticals and cosmetics. The fee for assessing confirmation of information content, drug and cosmetic advertising is 1.8 million VND per dossier.

The fee for assessing the licensing of marketing authorization of drugs and drug materials for initial registration and re-registration is 5.5 million VND per dossier; the fee for assessing the licensing of marketing authorization of drugs and drug materials for renewal registration is 3 million VND per dossier.

The fee for assessing the import license of medicinal ingredients and traditional medicine herbs is 200,000 VND per item. The fee for assessing the publication of cosmetic products and the announcement of medicinal herb standards is 500,000 VND per item.

Regarding the fee for assessing the standards and conditions for practicing and doing business in the fields of pharmaceuticals and cosmetics, the Circular stipulates: The fee for assessing the standards and conditions for cosmetic production to issue a GMP certification complying with CGMP-ASEAN; assessing the standards and conditions for drug and medicinal herb production (GMP); assessing the standards and conditions for pharmaceutical packaging production all have a fee of 20 million VND per establishment.

The fee-collecting organization shall remit all collected fees to the state budget. The funding for carrying out the tasks related to fee collection shall be allocated from the state budget within the estimate of the fee-collecting organization according to policies and state budget expenditure norms.

In cases where the fee-collecting organization is a state agency being allocated operating expenses from collected fee revenue according to the regulations of the Government of Vietnam, 70% of the collected fees can be retained to cover expenditure content as prescribed, and 30% of the collected fees must be remitted to the state budget.

Circular 277/2016/TT-BTC takes effect from January 1, 2017.

Source: Bnews

>> CLICK HERE TO READ THIS ARTICLE IN VIETNAMESE