How much does it cost to regularize a product at ANVISA?
The Sanitary Surveillance Inspection Fee (TFVS) is a reason for doubt for those who are going through this stage, after all there are different evaluation criteria and values that need to be taken into account.
In order for this matter to be clarified, Stone Okamont prepared this blog with the main information about fees. Remembering that we facilitate the entire regularization process, whether it is a product or a company in accordance with current legislation.
What you will see in this blog:
- What are the fees charged by ANVISA?
- How are ANVISA values defined?
- Who must pay the Health Surveillance Inspection Fee?
- How much is the Sanitary Surveillance Inspection Fee?
- How does Stone Okamont help you in this process?
- Clear your doubts.
What are the fees charged by ANVISA?
The Sanitary Surveillance Inspection Fee (TFVS) is collected in regulatory processes for products and services. Before any application to the Agency, such as registration, Operation Authorization, issuance of a Good Manufacturing Practices Certificate, among others, must be paid to TFVS.
How are ANVISA values defined?
ANVISA determines that the value of this fee is in accordance with the requested subject code, also equivalent to the Economic Size of the institution and the type of service requested. For this reason, it is important that proof of size be provided, as there may be a charge as if the company belonged to “Group I – Large”, without the real value provided for in the legislation.
Who must pay the Health Surveillance Inspection Fee?
This fee is generated for individuals and legal entities that requested ANVISA's services. Such as registration, product notification, AFE, CBPF, toxicological evaluations...etc.
How much is the Sanitary Surveillance Inspection Fee (TFVS)?
Just examine the Annexes of RDC 198/2017 to find out the amount that will be charged. The associated values contain the discounts and exemptions provided for in accordance with the Company Size framework and are consistent with the taxable event, linked to the petitioner codes.
How does Stone Okamont help you in this process?
Stone Okamont has qualified consultants to help your company make the correct proof of size, thus avoiding the payment of unnecessary amounts.
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