Regulatory Feasibility Study

Imagine that you have a product that is not clearly classified with Brazilian agencies because it can be used for both human and animal applications, or because of any other issue. You will have to decide to apply for registration but still not knowing what the requirements would be, the standards, forbidden or allowed ingredients or substances, or anything about Brazilian law. What is recommended in such case?

RAGB developed a service to attend to the necessities of companies that would like to know more about Brazilian regulatory requirements. By doing research, we can know the main information for a regulatory project before it happens. It can be done with MAPA and/or ANVISA.

About ANVISA

ANVISA – National Agency of Sanitary Surveillance (translated from BR-Portuguese) is the agency that handles human health and related products affairs, such as:

  • medical, dental, hospital or laboratorial devices or equipment
  • medical, dental, hospital or laboratorial softwares
  • sanitizers
  • cosmetics, perfumes, personal care products
  • food, supplements, food ingredients, materials in contact with food for packaging
  • medicine

About MAPA

MAPA - Ministry of Agriculture, Livestock and Supply – is the agency that handles the affairs regarding:

  • animal food, animal supplement, medicine, general animal related products
  • fertilizers, inoculants, soil conditioners, manures, composts
  • biological or chemical pesticides
  • drinks (ready to drink)
  • wines

Feasibility Study Report – what is the content?

It consists of a report that will let you know valorous information, such as:

  • List of necessary documents to apply for registration
  • Required test reports (if applicable)
  • Correct classification regarding the product
  • Forbidden or allowed substances according to the product category (and minimum/maximum amounts of each one)
  • Similar products that were registered
  • Company Licenses required to apply for product registration
  • Claims/advertising that you can not put in the publicity or print/label/package
  • Necessary information for the label/package/IFU to enter into Brazil

Generally, Feasibility Study is delivered 30 days after the application (it is necessary a few more days if your company needs it in any other language different than English). These 30 days can be precious to make sure the regulatory strategy is correct.

Feasibility Study (or Regulatory Feasibility Study) was created to help innovations to come faster into Brazilian market. With a lower investment, your company can know exactly what will be necessary to apply for your product registration in Brazil.

 

Click here to ask for a quotation.