Regulatory Affairs


The SM SOMARCA acts in the regulatory area, before the Ministry of Health and its regulatory agency - National Health Surveillance Agency (ANVISA), as well as in State and Municipal Health Surveillance and with the Ministry of Agriculture, Livestock and Supply.


Our aim is to provide consulting and regulatory, at various levels of supervision, with technically qualified professionals to meet the needs of the market of products of interest to health in relation to regulatory and bureaucratic procedures of these ministries.


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


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


We operate throughout the national territory, as well as provide services adequacy cadastre and registration of importers in Europe, Asia, Africa, Central and South Americas.


ANVISA

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The SM SOMARCA engaged in consulting and advisory capacity to the regulatory bodies and acts as mediator and attorney in the process of obtaining licenses, permits, registrations and registration of products.
The Health Surveillance System is composed by Brazilian National Health Surveillance Agency - ANVISA and the Sanitary Surveillance Sites (State and Municipal).
The legalization of the activities of the company is divided into two stages:
• License to Operate in Local Health Surveillance
• Operating Permit Officer at National Health Surveillance Agency - ANVISA

Our services ANVISA are:

PLANNING REGULATORY

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Prior to designing any activity, whether developing a project to import,
export or opening new sites of activity, it is important to know what the
normative and regulatory framework which is applied to that activity.

Thus, we chanced to mention that for each activity shall be exercised by
the company there are hundreds of rules that must be observed and that
determine how the activity should be developed. The flaw in this analysis
takes the company to incur the costs of regulation unexpected and often
create expectations for the commencement of activities that do not materialize.


The Purpose of a procurement advisory and consultancy for the preparation of a
regulatory plan is just to know these rules and do not expose the projects risks.

REGISTRATION OF ESTABLISHMENT

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For a company to act in the areas of medicine, drugs, pharmaceutical and related inputs,
as defined in Law No. 5,991, of December 17, 1973, as well as toiletries, cosmetics, perfumes
and household cleaning products, should possess Operating Permit for Company ANVISA (AFE ANVISA)
and Operating License issued by the Local Health
Surveillance under the Law 6.360/76.


The SM SOMARCA operates in advisory and consulting work for the technical application of the
Operating Permit Enterprise (AFE) in the National Health Surveillance Agency - ANVISA.

Companies operating in the food industry do not require the Operating Permit Company. In this
case, once obtained the License of the Sanitary Location (State or Municipal, by location), it should
be just that you register the company in the National Health Surveillance Agency - ANVISA for the
purpose of electronic application, to allow the registration of domestic and imported foods.

Services provided for the legalization of your company in the Departments of Health Surveillance - ANVISA and Places:

• Operating Licence in Sanitary Municipality or the State, depending on the location and
complexity of the activities to be legalized.
• Operating Permit Enterprise (AFE)
• Change / Enlargement / Reduction Activities in the Operation License in Sanitary and
Operating Permit Enterprise (AFE)
• Application for Special Authorization of Operation (AE) - Ordinance 344/1999;
• Application for Operating Permit Enterprise (AFE) for Pharmacies and Drugstores
• Renewal of License to Operate in Health Surveillance
• Annual renewal of AFE (Pharmaceutical Drugs, Medicines, Pharmacies and Drugstores)
• Compliance with requirements
• Daily monitoring of publications and manifestations of ANVISA (during the administrative procedure)
• Certification of Good Manufacturing Practices, Distribution and Storage Cosmetics,
Medicines, Health Products Household Cleaning and Sanitizing

REGISTRATION AND REGISTRATION OF PRODUCTS

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With proper adjustment of the company, we can access the registry and / or registration of products with ANVISA. The record after granted is published in the Official Gazette (Diário Oficial da União - Supplement VISA) authorizing the company holding the record to Import or Manufacture and Distribute the product domestically.

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

Products are subject to registration and registration:

FOOD: (i) novel foods, (ii) new ingredients, (iii) infant foods (iv) Food for Enteral Nutrition (v) New packaging technologies (recycled), (vi) Bioactive substances and probiotic isolates with claim properties functional and / or health.
HEALTH PRODUCTS - RELATED: (i) sets, reagents and materials intended for diagnosis, (ii) equipment and medical and hospital supplies, (iii) diagnostic imaging equipment, (iv) Dental equipment, (v) Equipment and hemotherapic diagnostic laboratory (vi) Tradioisótopos for diagnostic use in vivo, (vii) Radiopharmaceuticals and radioactive products used in diagnosis and therapy.
PRODUCT GRADE I registrable (IN N. 07/2010):. Electrical equipment under the regime of Sanitary Surveillance including parts and accessories.
PRODUCT GRADE II registrable (IN N. 07/2010): Materials for use in healthcare.
COSMETICS:. Cosmetics, toiletries and perfumes.
MEDICATIONS: (i) Specific Medicines (ii) New Drugs (iii) Similar Drugs (iv) Generic Drugs (v) Registration of Biological Products, hemotherapic (vi) Input Active Pharmaceutical Association (IFA).
Sanitizing: any chemical disinfectant action or purification.
CIGARETTES: any product derived or not smoke tobacco.

M.A.P.A - Ministry of Agriculture, Livestock and Food Supply

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The SM SOMARCA provides advice and consultancy to legal firms and products with MAPA (Ministry of Agriculture, Livestock and Supply), according to the legislation for the production, storage, distribution, import and export of animal and plant as well as wines, spirits and vinegar, products intended for use in farming and veterinary.
The role of the Ministry of Agriculture, Livestock and Supply (MAPA) is based on the pursuit of animal and vegetable organization of agribusiness production chain, the modernization of the agricultural policy of encouraging exports, the sustainable use of natural resources and welfare.
The MAP performs the sanitary inspection of animal products (milk, honey, meats, fish, poultry and their derivatives) and vegetable and drinks (soft drinks, juices, alcoholic and non-alcoholic). Also oversees wines, vinegars and products intended for use in agricultural activities (fertilizers, inoculants, lime and pesticides) and veterinary products (feed and food additives for animal feed, veterinary drugs, pet products for beautification etc.).

REGISTRATION OF ESTABLISHMENT

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Activities supervised by MAP are regulated by different standards. In the area of ​​animal products (milk, honey, meats, fish, poultry and their derivatives) there is the possibility of installing the Federal Inspection Service (SIF) or Title Establishment related (ER).
The areas of products intended for use in agricultural activities (fertilizers, inoculants, lime and pesticides) and veterinary products (feed and food additives for animal feed, veterinary drugs, pet products for beautification etc.) Require registration of establishment for their activities, so that each segment has its own standard, relating to technical and sanitary requirements and Good Operating Practices.

Some of our services for the legalization of your company in MAP:

• Installing the SIF (Federal Inspection Service);
• Requirement to Establish Relationship to obtain registration as Establishment related (ER);
• Registration of Establishment of the importer and / or manufacturers pharmacochemical for veterinary use;
• Registration of Establishment of the importer and / or manufacturers of veterinary drugs;
• Registration of Establishment of the importer and / or manufacturers fertilizer, inoculants, corrective;
• Establishment Registration importer, manufacturer or skimmer additives for animal feed;
• Establishment Registration importer, manufacturer or skimmer products intended for animal feed;
• Establishment and Renewal of Registration-related (ER);
• Renewal of Registration of Establishment of the importer and / or manufacturers pharmacochemical for veterinary use;
• Establishment Registration Renewal importer and / or manufacturers of veterinary drugs.

Good practices for manufacturer and fractionators

Appropriateness to the decree 6296/2007: Good practices for manufacturer and fractionators additives and products intended for animal feed.
For grant of registration of establishment in the area of additives and products intended for animal feed, Decree 6269/2007, provides the preview of all the dependencies, plant and equipment in accordance with good manufacturing practices established in the specific act Ministry of Agriculture, Livestock and Supply.
Establishments already registered in the MAP should suit the Decree and require inspection for verification of Good Manufacturing Practices, and sent on the 17th of November the CIRCULAR DFIP No. 34/08, on the procedures for adjusting the Regulation of Law 6.198/74, approved by Decree 6.296/07, according to craft businesses that do not manifest themselves until the date of 18/12/2008 would have deregistered in accordance with Article 114 of that regulation being thus prevented to perform the activities therein.

PRODUCT REGISTRATION

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The SM SOMARCA elaborates processes for Product Registration in the Ministry of Agriculture. The products subject to registration are: animal products, pharmacochemical and veterinary pharmaceuticals, fertilizers, inoculants, corrective, additives and products intended for animal feed.

Thus, the scope of our work is to develop the process for registration of products, which are:

• Registration of products of animal origin;
• Registration pharmacochemical for veterinary use;
• Registration of veterinary drugs;
• Registration of fertilizers, inoculants, corrective;
• Registration of additives in animal nutrition;
• Registration of products intended for animal feed;

 

These products are under the supervision of the MAP:

• Animal products (beef, pork, poultry, eggs, fish, milk and dairy products, honey, and their derivatives);
• Fertilizers, inoculants, corrective;
• Additives for use in animal nutrition (acidifiers, preservatives, dyes, vitamins, minerals, probiotics etc..);
• Products intended for animal feed, except for pets;
• All chemical, biological, biotechnological or preparation manufactured, whose administration is done individually or collectively, directly or mixed with food, for the prevention, diagnosis, cure or treatment of animal diseases;
• additives, supplements, promoters, enhancers of animal production, antiseptics, disinfectants use or environmental equipment and livestock facilities, pesticides;
• All products used in animals or their habitat, protect, restore or modify their organic and physiological functions, and products for hygiene and beautification of animals.