Registrations, Records, Licenses
All products, after proper company regularization, must be Registered, Registered and/or Notified before the National Health Surveillance Agency (ANVISA).
After the approval of the Registration/Registration process has been published in the Federal Official Gazette (DOU - ANVISA Supplement), the company holding the registration is qualified to Manufacture or Import and distribute the product throughout the national territory.
Setty Regulatory Affairs offers full technical and legal support for the Registration, Registration and Notification of its products. The following services are provided for the Registration, Registration and Notification of your Products:
Medicines
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Obtaining a Specific Medicine Registration with the National Health Surveillance Agency (ANVISA);
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Obtaining a New Medicine Registration with the National Health Surveillance Agency (ANVISA);
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Obtaining a Similar Medicine Registration with the National Health Surveillance Agency (ANVISA);
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Obtaining a Generic Drug Registration before the National Health Surveillance Agency (ANVISA);
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Obtaining the Registration of Biological and Hemotherapy Products before the National Health Surveillance Agency (ANVISA);
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Obtaining the Registration of Active Pharmaceutical Ingredient (IFA) before the National Health Surveillance Agency (ANVISA);
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Obtaining Renewal of Medication Registration in general before the National Health Surveillance Agency (ANVISA);
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Alteration of the Registration of Medicines in general before the National Health Surveillance Agency (ANVISA).
cosmetics
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Obtaining Grade II Cosmetic Product Registration before the National Health Surveillance Agency (ANVISA);
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Obtaining Grade I Cosmetic Product Notification from the National Health Surveillance Agency (ANVISA);
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Obtaining the Grade II Cosmetic Product Registration Renewal before the National Health Surveillance Agency (ANVISA);
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Change of Registration/Notification of Cosmetic Product before the National Health Surveillance Agency (ANVISA);
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Obtaining Free Sales Certificate for Cosmetic Products.
sanitizing
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Obtaining Risk II Sanitizing Product Registration before the National Health Surveillance Agency (ANVISA);
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Obtaining Risk I Sanitizing Product Notification from the National Health Surveillance Agency (ANVISA);
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Obtaining Renewal of Risk II Sanitizing Product Registration before the National Health Surveillance Agency (ANVISA);
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Alteration of Sanitizing Product Registration/Notification before the National Health Surveillance Agency (ANVISA);
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Obtaining a Certificate of Free Sale for Sanitizing Products.
Foods
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Obtaining the Registration of New Foods and New Ingredients before the National Health Surveillance Agency (ANVISA);
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Obtaining the Registration of Foods with Isolated Substances and Probiotypes with a functional and/or Health claim before the National Health Surveillance Agency (ANVISA);
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Obtaining a Child Food Registration before the National Health Surveillance Agency (ANVISA)
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Obtaining the Food Registration for Enteral Nutrition before the National Health Surveillance Agency (ANVISA);
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Obtaining the Registration of Recycled Food Packaging before the National Health Surveillance Agency (ANVISA);
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Obtaining Food Registration Renewal before the National Health Surveillance Agency (ANVISA);
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Amendment of Food Registration before the National Surveillance Agency;
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Adequacy of Labeling, Labeling Words and Nutritional Table of Foods submitted for Free Sale, in the manner required by the Consumer Protection Code and National Sanitary Legislation.