19:24 | Bsb, 9/4/2010
 
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Visanco has had the opportunity to participate on several technical regulation processes in the scope of the National Agency of Sanitary Surveillance – ANVISA and the Ministry of Agriculture – MAPA, in work groups or contributions to public consultation, and in its consolidation, representing associations of food and drugs sectors.

Visanco has also acted in the innovation of various products classified as Novel food/ingredients, and Food products with Health and or Functional Properties claims.

Visanco has technically structured processes of technology transfer, inclusion and standardization of essential, high cost and complexity drugs in the scope of the Ministry of Health, states and municipalities, enabling the acquisition of these drugs by the public sector, guaranteeing free access to patients assisted by the Brazilian National Health System.

Cases in the field of Food and Nutrition:

  • Administrative Order Nº 27/98 – Technical Regulation on Complementary Nutritional Information (declarations related to nutrients content);

  • Administrative Order Nº 28/98 – Technical Regulation on Additives for Food with Complementary Nutritional Information and Special Purposes Food Products;

  • Administrative Order Nº 29/98 – Technical Regulation on Special Purposes Food Products;

  • Administrative Order Nº 30/98 – Technical Regulation on Weight Control Food Products;

  • Administrative Order Nº 31/98 – Technical Regulation on Essential Nutrients Added Foods;


  • Administrative Order Nº 32/98 – Technical Regulation on Vitamins-Minerals Supplements;

  • Administrative Order Nº 33/98 – Technical Regulation on DRI – Dietary Reference Intakes (cancelled by Resolution RDC nº 269/05);

  • Administrative Order Nº 34/98 – Technical Regulation on Transition Food for Infants and First Childhood Children;

  • Administrative Order Nº 36/98 – Technical Regulation on Cereal based Foods for Child Food;

  • Administrative Order Nº 40/98 – Technical Regulation on Maximum Secure Levels of Vitamins and Minerals on Drugs;

  • Administrative Order Nº 222/98 – Technical Regulation on Food Products for Physical Activity;

  • Administrative Order Nº 868/98 – Technical Regulation on Ready to Consume Liquid Compound (cancelled by Resolution RDC nº 273/05);

  • Resolution Nº 16/99 – Technical Regulation on New Food Products;

  • Resolution Nº 17/99 – Food Risk and Safety Assessment;

  • Resolution Nº 18/99 – Technical Regulation that establishes the basics guidelines for analysis and proof of functional and or health properties claimed in food labeling;

  • Resolution Nº 19/99 – Technical Regulation on procedures for registry of food with functional and or health properties claims on its label;

  • Resolution RDC Nº 02/02 – Technical Regulation on Bioactive substances and Probiotics;

  • Resolution RDC Nº 263/05 – Technical regulation on cereals, starches, flours and bran products;

  • Resolution RDC Nº 264/05 – Technical Regulation on chocolate and cocoa products;

  • Resolution RDC Nº 265/05 – Technical Regulation on candies, chocolate and chewing gums;

  • Resolution RDC Nº 266/05 – Technical Regulation on Iced products and Preparations for iced Products;

  • Resolution RDC Nº 267/05 – Technical Regulation on vegetables species for tea preparation;

  • Resolution RDC Nº 268/05 – Technical Regulation on Protein Foods of Vegetable Origin;

  • Resolution RDC Nº 269/05 – Technical Regulation on Protein, Vitamins and Minerals Dietary Reference Intakes (DRI);

  • Resolution RDC Nº 270/05 – Technical Regulation on Vegetable oils, vegetable fat and vegetable creams;

  • Resolution RDC Nº 271/05 – Technical Regulation on Sugar and Sweetening products;

  • Resolution RDC Nº 272/05 – Technical Regulation on Vegetable products, fruit products and eatable mushrooms;

  • Resolution RDC Nº 273/05 – Technical Regulation on Mixes for food preparation and ready-to-eat food products;

  • Resolution RDC Nº 274/05 – Technical Regulation on bottled waters and ice;

  • Resolution RDC Nº 275/05 – Technical Regulation on microbiologic characteristics for natural mineral water and natural water;

  • Resolution RDC Nº 276/05 – Technical Regulation on spices, seasoning and sauces;

  • Resolution RDC Nº 277/05 – Technical Regulation on coffee, barley, tea, mate herb and soluble products;

  • Resolution RDC Nº 278/05 – Approves the categories of food and packages dismissed and with obligatory registration;

  • Administrative Order Nº 287/06 – Approves technical regulation on modified powdered milk;

  • Administrative Order Nº 288/06 – Approves technical regulation on dairy compound;

  • Administrative Order Nº 289/06 – Approves technical regulation on aromatized milk;

  • Bill concerning Natural Origin Products for Health (ABIFISA);

  • Proposal for a new technical regulation: Food products for athletes (ABENUTRI and ABIAD);

  • Approval of the first Omega 3 Milk for the market, in 2000;

  • Market studies, with assessment of Brazilian manufacturers and importers of food products, qualified as nutritional supplements, functional foods, novel products and bioactive foods;

  • Actions on elaboration of guidelines for the National Program of School Nourishment Activities Planning – PNAE;

  • Elaboration and approval of the first registration processes of probiotics, lycopene, soy germ, safflower oil and colostrums;

  • Elaboration and advisement on evaluation processes of safety and efficacy of the following products: collagen, lycopene, diacylglicerol, fish oil, lutein, colostrum, resistant starch, soy germ, safflower oil, glutamine, among others;


  • Approval of collagen use in compound beverages, in 2006;
  • Market studies and viability of blood products in the country;
  • Approval of other food “supplements” due to the current legislation: primrose, borage, wheat germ, egg lecitin, soy lecitin, vegetables in capsules, graviola, collagen, gelatin, fish gelatin, dietary fibers, energy drinks, protein food for athletes, compensators, replacers, among others;

  • Elaboration of scientific well based processes, regarding innovating products, that haven’t yet been regulated as Novel Food Products or Functional Properties Claims by ANVISA.

Cases in the Pharmaceutical field:

  • Administrative Order Nº 185/99 – Establishes the procedures for acquisition of Drugs Importers and Exporters Operating License;

  • Administrative Order Nº 40/98 – Drugs based on vitamins and minerals;

  • Resolution RDC Nº 48/04 – Establishes the procedures for the registration of Herbal Medicines;

  • Bill concerning Natural Origin Products for Health (ABIFISA);

  • Participation on Pharmaceutical Sector Competitiveness Forum;


  • Participation on the ratification of several Public Consultations in the fields of drugs, cosmetics, health products and sanitizing products;

  • Actions on work groups on pharmaceutical inputs;

  • Elaboration and approval of registration processes of drugs, cosmetics, health products and sanitizing products;

  • Inclusion approval of Olanzapin and Raloxifene on the exceptional drugs list of the Brazilian National Health System;

  • Extension approval of the Olanzapina drug for hospital use;


  • Inclusion of the drug Tenofovir on the National Program of STD/AIDS, participating in the drug price approval along with CMED;

  • Inclusion of the drug Atazanavir on the National Program STD/AIDS, participating in the drug price approval along with CMED;

  • Standardization and trading of the drug Implanon on the States of Mato Grosso do Sul and Family Planning State Program of Mato Grosso;

  • Market and feasibility studies related to blood products in Brazil;;

  • Standardization of the drug Xigris (active drotrecogin alfa) in the State of Parana;


  • Participation on drugs technology transfer processes between private and public sectors;

  • Personnel qualification, training, and pre-audit on Good Manufacturing Practices and Control aiming the GMP certification of ANVISA for Chinese, Indian, Japanese, Mexican, American, Argentine, and German companies, among others.

 
 
 

 
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