Holder Service or Hosting is a service provided by a company that already has its Operating License and Company Operation Authorization approved and issued by the brazilian National Health Surveillance Agency (ANVISA). This company grants its license and its AFE to a foreign company to register, import / export its product. This service cannot be used to store, distribute or manufacture the product.
The product hosting service is intended only for international companies that wish to register their products in Brazil. To operate in the Brazilian market, the company needs the Operating License and the Company Operating Authorization (AFE), as required by Brazilian law.
Therefore, there are only three ways to regularize your product in Brazil:
Through a regularized distributor;
Creating a corporation in Brazil with the appropriate licenses and authorizations;
Through a BRH (Brazilian Registration Holder Services).
As a strategic way of regularization, the International Product Hosting facilitates the regulatory process of companies and products, that’s because the BRH already has all the licenses and authorizations necessary for the company use and the immediate start of the registration processes.
The products that can be registered using the BRH method are cosmetics, hygiene products and perfumes, health products, materials and equipment, in vitro diagnostics, food, sanitizing and cleaning products.
If your company produces risk class levels III and IV products, Stone Okamont has qualified professionals with international experience to assist in the Certification of Good Manufacturing Practices (CBPF) at ANVISA and harmonize the company's Quality System in accordance with the Brazilian regulation.
Some benefits of a Holder Service:
In addition to having an extremely qualified team in the regulatory affairs, we have an Operating License and Company Operating Authorization (AFE), enabling your regularization at ANVISA.
Request a quote here.