ADVICE AND CONSULTING ON REGULATORY AFFAIRS AND FOREIGN TRADE

We have the expertise and full capacity to provide our customers with comprehensive advice and walk them through the paperwork of Foreign Trade with the relevant agencies and in compliance with the legal requirements for each product in a discerning manner.

MINISTRY OF AGRICULTURE (MA)

The Ministry of Agriculture, Supply and Agrarian Reform is the federal agency which regulates and controls companies that produce, distribute and store products of animal and plant origin.

Line of business:

• Products of animal origin (beef, pork, poultry, eggs, fish, milk and dairy, etc.)
• Fresh produce of plant origin (e.g. fruit, vegetable and legumes, seeds, etc.);
• Manufactured and processed goods (e.g. vegetable oils based on soybeans, corn, cotton, olive, etc.);
• Farming inputs;
• Processed plant products;
• Beverages;
• Wines and vinegars;
• Wine and grape derivatives;
• Plant multiplication materials;
• Plant multiplication materials;

Country qualification

We advise countries that have never exported to Brazil to help them meet the key requirements for approval by the Ministry of Agriculture and for subsequently enabling the other procedures for becoming trade partners.

Accreditation of international businesses

Any businesses willing to export products of animal origin to Brazil shall meet the requirements set forth in the country’s specific laws and regulations. Such requirements may relate to the condition of facilities, equipment, operating flow chart, technological processes, use of best manufacturing practices, and the adoption of food safety assurance methodologies recommended by the CODEX ALIMENTARIUS.

Product registration

All foreign businesses qualified to export to Brazil shall meet the formal requirements for approval of Label Registration and submit a brief of manufacturing, quality control and other key information for approval.

MINISTRY OF HEALTH (MS)

The Ministry of Health is the authority responsible for preparing and making public policies and plans to promote the health, prevent diseases and provide healthcare for Brazilians. Some agencies are not part of the Ministry of Health’s central structure, but conduct their activities in connection therewith. Such is the case of the National Sanitary Authority (ANVISA), a quasi-governmental agency that plays specific roles and perform complementary activities that must be in line with the main Health issues and government priorities. The institutional purpose of the ANVISA is to foster the population’s health protection by regulating, controlling and inspecting goods and services, including the relevant environments, processes, materials and technologies.

Products subject to sanitary control and inspection:

• Medication for human use, active ingredients and other materials thereof, as well as related processes and technologies;
• Foods, beverages, bottled water and related inputs, packaging materials, food additives, organic contaminant limits, traces of agrochemicals and veterinary medication;
• Related health products;
• Cosmetics, personal hygiene products and perfumes;
• Cleaning products for sanitation, disinfection and disinfestation of household, hospital and collective environments;
• Diagnostic kits, reagents and materials;
• Medical and hospital, dental, hemotherapeutic, laboratory diagnosing and diagnostic imaging equipment and materials;
• Immunobiological substances and active ingredients thereof, blood and blood products;
• Human and veterinary organs and tissues for use in transplants or regeneration;
• Radioisotopes for in vivo diagnosis, radiopharmaceuticals and radioactive products used in diagnosis and therapy;
• Cigarettes, cigarillos, cigars and any other smoking products, whether or not tobacco derivatives;
• Any products involving potential risks to health produced by genetic engineering or any other procedures or subject to radiation sources;

Services subject to sanitary control and inspection:

• Those designed for ambulatory care, whether in routine or emergency procedures, those performed during hospitalization, diagnostic and therapeutic support services, and those involving the incorporation of new technologies;
• The facilities, equipment, technologies, environments and procedures involved in all stages of the production processes for products subject to sanitary control and inspection, including the disposal of related waste.

Operation Permit (AF)

Only companies authorized by the Ministry of Health (ANVISA) may extract, produce, manufacture, process, synthesize, purify, fraction, pack, repack, import, export, store and ship products controlled by the ANVISA. We advise and file applications for these companies according to the ANVISA rules.

State Sanitary Inspection Registration (CEVS)

All importers and distributors of healthcare products who do not own storage facilities shall file for State Sanitary Inspection Registration.

We advise and file applications for these companies, following the rules of Sanitary Inspection Authorities and according to the regulations of the relevant Municipalities.

Operation License (LF)

Only businesses licensed by the sanitary authority of the State where they are located may extract, produce, manufacture, process, synthesize, purify, fraction, pack, repack, import, export, store and ship products controlled by the ANVISA.

We advise and file applications for these companies, in compliance with the rules issued by the local Sanitary Authorities.

Certification of Best Manufacturing Practices (BPF)

Before marketing certain products, companies are required to implement Best Manufacturing Practices (BPF, in Portuguese) and have them certified, which practices consist of a set of requirements imposed by the ANVISA on manufacturers and distributors of health-related products. In other words, they are a Quality Management System.

We will provide information on all of the requirements applicable to any businesses which manufacture or market products requiring best manufacturing practices in order to assure the quality of the process aiming for the safety, effectiveness and control of consumer health risk factors.

Product Registration

All “healthcare products” or “related products” may only be manufactured or imported upon registration approved by the ANVISA.

The registration requirement is applicable to most such products.

However, it is our duty to advise that before applying for registration, a company needs an Operation Permit issued by the ANVISA, which means that before applying for registration, the company shall file an application for Operation Permit.

Domestic products must be registered with the ANVISA by their manufacturers, who are required to have an Operation Permit issued by the ANVISA to Manufacture Healthcare Products (related products).

Imported products must be registered with the ANVISA by the importing companies, which are required to have an Operation Permit issued by the ANVISA for Importing and Distributing Healthcare Products (related products).

Companies in other lines of business (cleaning products, cosmetics, medication, sanitation products, perfumes, etc.) must apply for Permits specific to their business segment.

Hauling companies must apply for an Operation Permit for Transportation of healthcare products (related products).

We enable all of the studies required for classifying any products intended to be marketed, conducting research and assisting the concerned companies with their needs and pre-requisites for approving the registration and marketing of such products.

In addition, we prepare registration amendment and revalidation processes with the ANVISA.

MINISTRY OF DEVELOPMENT, INDUSTRY AND FOREIGN TRADE (MDIC)

The Ministry of Development, Industry and Foreign Trade is responsible for matters pertaining to intellectual property, technology transfer, metrology, industrial standardization and quality, foreign trade policies, regulation and implementation of foreign trade-related programs and activities, application of fair trade mechanisms, participation in foreign trade-related international negotiations, making of support policies for micro-sized businesses, small businesses and craftsmanship, and performance of trade registration activities.

National Industrial Property Institute (INPI)

The National Industrial Property Institute (INPI) is a federal quasi-governmental agency related to the Ministry of Development, Industry and Foreign Trade responsible for trademark registration, patent grants, registration of technology transfer and business franchising agreements, and registration of computer programs, industrial design and geographic indications.

Its purpose is to serve as a capacity-building and competitiveness tool, while creating essential conditions for leveraging the nation’s technological and economic development.

Trademark Registration

A trademark is a visually noticeable distinctive mark that identifies and differentiates a product and/or service from other similar or related products and/or services of different origins or certifies the compliance thereof with certain technical standards or specifications. We conduct the Trademark Registration procedure, advising the company on all adversities and peculiarities of such service.

Before filing a trademark registration application with the INPI, we make the following arrangements: previous search for similar trademarks, analysis of the trademark composition to prevent it from containing any such marks, letters or expressions as are not permitted and therefore cannot be registered.

Trademark rights are vested by a validly issued registration, the holder of which is assured an exclusive right to use the registered trademark throughout the national territory.

Patents

A patent is a temporary property instrument concerning an invention or utility model, which is granted by the State to the inventors, authors or other individuals or legal entities who own the rights on the relevant creation. In turn, the inventor binds himself to disclose in detail all of the technical contents of the material protected by the patent. We advise patent holders on all of the stages involved in the filing of patent applications, until approval for grant throughout the national territory.

It is our duty to inform that numerous stages make up the process of filing for a patent application, and that there are several actions that cannot be patented for trademarks. Therefore, we advise, direct and analyze all of the processes before filing a Patent application.

It is worth pointing out that it is not easy to obtain patent rights due to the very patent application filing process and the number of patents awaiting clearance. There are approximately 130,000 patent applications awaiting approval. Each year, more than 17,000 new applications are filed, and the public agency simply does not have enough employees to review so many applications. As a result, it takes eight years, on average, to obtain a patent, according to INPI president Roberto Jaguaribe.

Industrial Design

Industrial design means all ornamental plastic shapes of an object or set of ornamental lines and colors that can be applied to a product, creating a new, original visual result in its external configuration, and that may serve as an industrial production type.

We provide advice on the development of the entire process until approval of registration by the INPI.

A Registration of Industrial Design (DI, in Portuguese) is a temporary property instrument concerning an industrial design which grants to its holder, for its duration, a right to exclude third parties, without any previous consent, from any acts pertaining to the protected object, such as manufacturing, marketing, importing, using, selling, etc.

National Institute of Metrology, Standardization and Industrial Quality (INMETRO)

This Institute is responsible for carrying out national metrology and quality policies for materials and products, as well as incentivizing productivity, keeping and preserving standards for measurement units, and implementing and keeping the traceability chain of measurement unit standards in the country, so as to make them domestically harmonic and internationally compatible, aiming primarily at their universal acceptance and secondarily at the use thereof as support for the manufacturing sector with a view to ensuring the quality of goods and services.

We provide advice for companies to adjust their products for the standards and certifications required by the INMETRO.

Labeling

We conduct label studies, adapting labels for the regulations and technical standards applicable to each product, thereby enabling the product to be directly sold to consumers.

Brazilian Compliance Assessment System (SBAC)

Compliance Assessment is the process of “demonstrating that the requirements specified for a certain product, process, system, person or organization are met according to the applicable standards or regulations, at the lowest possible cost to society.

Our advice assists businessmen in obtaining such Certification, providing greater safety for consumers.

MINISTRY OF LABOR AND EMPLOYMENT (MTE)

The Ministry of Labor and Employment, through the Occupational Safety and Health Program, seeks to protect the life and foster the safety and health of workers by certifying companies which produce or import Personal Protection Equipment (PPE).

Certificate of Approval

Some products need a Certificate of Approval issued by the relevant national agency concerned with occupational safety and health under the Ministry of Labor and Employment.

This is an important procedure for assuring workers that the equipment that they use was certified and will provide them with personal protection.

Any equipment and products subject to the relevant resolutions require such certification, whether they are domestically produced or imported, and may only be put up for sale upon approval by the Ministry of Labor.

We conduct all of the relevant research efforts and provide advice for obtaining such certification where required by our authorities.

MINISTRY OF THE ENVIRONMENT (MMA)

The mission of the Ministry of the Environment is to foster the adoption of principles and strategies designed to ensure knowledge, protection and recovery of the environment, a sustainable use of natural resources, the appreciation of environmental services, and the inclusion of sustainable development in the making and implementation of governmental policies in a cross-span, shared, participatory and democratic manner, at all levels and instances of government and society.

Environmental Permit

The environmental permit is a statutory requirement to be met prior to the implementation of any undertaking or activity which is potentially pollutant or detrimental to the environment, and one of its most significant features is the participation of society in the decision-making process.

This requirement is shared by the State Environmental Agencies and the IBAMA, as integral parts of the SISNAMA (National Environmental System)

We provide entrepreneurs with advice so that they can meet all of the requirements for obtaining the Permit from the IBAMA.