Anvisa

Regulatory Affairs SM SOMARCA operates in the regulatory area, before the Ministry of Health and its regulatory agency - Agência Nacional of Health Surveillance (ANVISA) , as well as in the State and Municipal Health Surveillance Secretariats and before the Ministry of Agriculture, Livestock and Supply.

Our object is to provide regulatory consultancy and advice, at different levels of inspection, with technically qualified professionals to meet the needs of the market for products of interest to health, with regard to the regulatory and bureaucratic procedures of these ministries.

Our services are provided in a personalized way, according to the interests and needs of each client. SM SOMARCA provides its services to: manufacturers, fractionators, importers, distributors and transporters of food, pharmaceutical supplies, medicines, health equipment (related), cosmetics, sanitizing products, veterinary products and products intended for animal feed.

To better serve our customers, SM SOMARCA has professionals to carry out the procedural steps in Brasilia.

We operate throughout the national territory, as well as provide services for adjusting the registration and registration of importers from Europe, Asia, Africa, Central and South America .



SM SOMARCA provides consultancy and assistance to regulatory bodies and acts as an intermediary and attorney in the process of obtaining licenses, authorizations, registrations and product registration.

The Brazilian Health Surveillance System is comprised of the National Health Surveillance Agency - ANVISA and Local Health Surveillance (State and Municipal).

The legalization of the company's activities is divided into two stages:


  • Operating License for Local Health Surveillance
  • Authorization for the Operation of a Company at the National Health Surveillance Agency - ANVISA

Prior to the conception of any activity, whether it is the development of an import, export project or the opening of new activity sites; it is important to know which regulations and which regulations are applied to that activity.

In this way, we risk saying that for each activity that will be performed by the company there are hundreds of rules that must be observed and that determine how the activity should be developed.

The failure in this analysis leads the company to bear unexpected regularization costs and often create expectations for the start of activities that do not materialize.

The objective of hiring consultants and consultants to prepare a regulatory plan is precisely to know these rules and not expose projects to risks.

In order for a company to be able to operate in the areas of medicines, drugs, pharmaceutical inputs and related products, defined in Law No. 5,991, of December 17, 1973, as well as hygiene products, cosmetics, perfumes and sanitizing products, it must have Authorization of Operating Company at ANVISA (AFE Anvisa) and Operating License issued by the Local Health Surveillance, under the terms of Law No. 6.360 / 76.

SM SOMARCA acts in the advisory and technical consultancy work for the application of the Company Operation Authorization (AFE) at the National Health Surveillance Agency - ANVISA.

Companies that operate in the food industry do not require the Authorization for the Operation of a Company.

In this case, once the Local Health Surveillance License (State or Municipal, depending on the location) has been obtained, the company should only be registered with the National Health Surveillance Agency - ANVISA, for the purposes of electronic petition, in order to to allow the registration of national or imported foods.


Services provided for the legalization of your company in the Secretaries of Health Surveillance - Local and ANVISA:


  • Operating License in the Municipal or State Health Surveillance, depending on the location and complexity of the activities to be legalized;
  • Company Operation Authorization (AFE);
  • Alteration / Expansion / Reduction of Activities in the Operating License in Health Surveillance and in the Authorization for the Operation of the Company (AFE);
  • Application for Special Operating Authorization (AE) - Ordinance 344/1999;
  • Application for Business Operation Authorization (AFE) for Pharmacies and Drugstores;
  • Renewal of Operating License for Health Surveillance
  • Annual renewal of AFE (Pharmaceutical Inputs, Medicines, Pharmacies and Drugstores);
  • Compliance with requirements;
  • Daily monitoring of ANVISA publications and manifestations (during the administrative process);
  • Certification of Good Manufacturing, Distribution and Storage Practices for Cosmetics, Medicines, Health Products and Household Cleaning Products

With the due regularization of the company, we can achieve the registration and / or registration of products with ANVISA . The registration, after approval, is published in the DOU (Diário Oficial da União - ANVISA Supplement) authorizing the company that owns the registration to Import or Manufacture, as well as to distribute the product in national territory.

However, there are products that do not require registration, but registration. This procedure is nothing more than a simplified product registration and has the same purpose as a registration, that is, to guarantee the quality and safety of the product with the final consumer. This type of legalization is used in the registration of correlated Risk Degrees I and II (which are not included in the IN 07/2010 list).

These are products subject to registration and registration


FOOD: (I) Novel foods; (ii) new ingredients; (iii) infant foods; (iv) Food for Enteral Nutrition; (v) New technology packaging (recycled); (vi) Bioactive substances and isolated probiotics with claims of functional and / or health properties.

HEALTH PRODUCTS - RELATED: (i) Sets, reagents and supplies for diagnostics; (ii) Medical and hospital equipment and materials; (iii) Imaging diagnostic equipment; (iv) Dental equipment; (v) Hemotherapy and laboratory diagnostic equipment; (vi) Tradioisotopes for use in in vivo diagnosis; (vii) Radiopharmaceuticals and radioactive products used in diagnosis and therapy.

GRADE I PRODUCTS subject to registration (IN N. 07/2010): Electrical equipment under the Health Surveillance regime including its parts and accessories.

GRADE II PRODUCTS subject to registration (IN N. 07/2010): Materials for use in health.

COSMETICS: Cosmetics, personal care products and perfumes.

MEDICINES: (i) Specific Medicines; (ii) New Medicines; (iii) Similar Drugs; (iv) Generic Medicines; (v) Registration of Biological and Hemotherapy Products; (vi) Active Pharmaceutical Input (IFA).

SANEANTES: any disinfectant or purifying chemical.

CIGARETTES: any smoking product derived or not from tobacco.


SM SOMARCA advises and advises on the legalization of companies and products with MAPA (Ministry of Agriculture, Livestock and Supply) , in accordance with current legislation for the production, storage, distribution, import and export of products of animal and vegetable origin, as well as wines, beverages and vinegars, products intended for use in agricultural activities and for veterinary use.

The work of the Ministry of Agriculture, Livestock and Supply ( MAPA ) is based on the search for animal and plant health in the organization of the agribusiness production chain, the modernization of agricultural policy, the incentive to exports, sustainable use of natural resources and social welfare.

MAPA carries out sanitary inspection of products of animal origin (milk, honey, meat, fish, poultry and their derivatives) and vegetable products and beverages (soft drinks, juices, alcoholic and non-alcoholic drinks) alcoholic beverages). It also inspects wines, vinegars and products intended for use in agricultural activities (fertilizers, inoculants, corrective and pesticides) and products for veterinary use (additives and foods for animal feed, veterinary medicines, products for animal beautification, etc.).


The activities inspected by MAPA are regulated by several rules. In the area of ​​products of animal origin (milk, honey, meat, fish, poultry and their derivatives) there is the possibility of installing the Federal Inspection Service (SIF) or Related Establishment Title (ER).

The areas of products intended for use in agricultural activities (fertilizers, inoculants, corrective and pesticides) and products for veterinary use (additives and foods intended for animal feed, veterinary medicines, products for animal beautification etc.) require registration of the Establishment for its activities, so that each of the segments has its own standard, referring to technical-sanitary requirements and Good Operational Practices.


Some of our services provided for the legalization of your company on the MAP:


  • Installation of the SIF (Federal Inspection Service);
  • Establishment Relationship Requirement, to obtain Registration as a Related Establishment (ER);
  • Registration of Establishment of importer and / or manufacturers of pharmaco-chemicals for veterinary use;
  • Registration of Establishment of importer and / or manufacturers of veterinary drugs;
  • Registration of establishment of importer and / or manufacturers of fertilizers, inoculants, correctives;
  • Registration of an importer, manufacturer or fractionator of additives intended for animal feed;
  • Registration of an importer, manufacturer or fractionator of products intended for animal feed;
  • Renewal of Registration as a Related Establishment (ER);
  • Renewal of Registration of Establishment of importer and / or manufacturers of pharmaceutical chemicals for veterinary use;
  • Renewal Registration of Establishment of importer and / or manufacturers of veterinary drugs.


Good practices for manufacturers and fractionators


Adequacy to Decree 6296/2007: Good practices for manufacturers and fractionators of additives and products intended for animal feed.

In order to grant the establishment record, in the area of ​​additives and products intended for animal feed, Decree 6269/2007 determines the prior inspection of all facilities, installations and equipment, in accordance with the good manufacturing practices, established in a specific act of the Ministry of Agriculture, Livestock and Supply.

Establishments already registered with MAPA must comply with the Decree and request inspection for verification of Good Manufacturing Practices, with the CIRCULAR CIRCULAR DFIP nº 34/08 on the procedures for adapting to the Regulation of Law 6.198 / 74, approved by DECREE 6.296 / 07, according to the letter, companies that did not manifest themselves until the date of 18/12/2008, would have their registrations canceled, in accordance with article 114, of the said regulation, therefore, prevented from carrying out the activities provided for in it.


SM SOMARCA prepares the processes for Product Registration at the Ministry of Agriculture. The products subject to registration are: products of animal origin, pharmaco-chemicals and medicines for veterinary use, fertilizers, inoculants, correctives, additives and products intended for animal feed.

Thus, the scope of our work is to elaborate the entire process for product registration, namely:


  • Registration of products of animal origin;
  • Registration of veterinary pharmacochemicals;
  • Registration of veterinary drugs;
  • Registration of fertilizers, inoculants, correctives;
  • Registration of additives for animal feed;
  • Registration of products intended for animal feed

These are products that are under the supervision of MAPA:


  • Products of animal origin (beef, pork, poultry meat, eggs, fish, milk and dairy products, honey, as well as their derivatives);
  • Fertilizers, inoculants, correctives;
  • Additives for animal feed (acidifiers, preservatives, dyes, vitamins, minerals, probiotics, etc.);
  • Products intended for animal feed, except for pets;
  • All chemical, biological, biotechnological or manufactured substances, which are administered individually or collectively, directly or mixed with food, intended for the prevention, diagnosis, cure or treatment of animal diseases;
  • Additives, supplements, promoters, animal production improvers, antiseptics, disinfectants for environmental use or in livestock equipment and facilities, pesticides;
  • All products that, used in animals or in their habitat, protect, restore or modify their organic and physiological functions, and products intended for hygiene and the beautification of animals.
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