Authorization and Licenses

The Brazilian System of Public Health Surveillance is formed by ANVISA – National Agency of Health Surveillance – and by Local Health Surveillances (State and Municipal).

Through consultancy services to obtaining of authorizations and licenses, Amaral & Cia is eligible to provide in both steps of the legalization process. We are also qualified and prepared to provide all consultancy to obtaining licenses with other agencies, such as the Fire Brigade and Cetesb. Included with these services are bureaucratic documentations step, in addition of diagnosis, technical inspection reports, researches, inspections, trainings, audits and evaluations.

The legalization of the activities of a company is divided in two steps:

1 - License of Operation (Local Health Surveillance):

• 1.1 - Elaboration and follow-up of administrative procedures to obtaining the License of Operation (with ANVISA and/or MAPA);

• 1.2 - Viability Research, layout and projects for approval in Health Surveillance agencies and in the Ministry of Agriculture;

• 1.3 - Courses and trainings in Good Practices of Distribution and Manufacturing;

• 1.4 - Elaboration and implantation of MBP – Manual of Good Practices – and POP – Standardized Operational Procedures;

• 1.5 - Diagnosis of company status to detect possible irregularities or disagreements in relation to legal requirements relevant to each field of work, assessing facilities, documentations and procedures;

• 1.6 - Defense and administrative resources in actions derived from irregularities (Violation Notice, Penalty Notice, apprehensions, interdictions, dismissals, with ANVISA);

2 - Authorization of Operation (ANVISA):

• 2.1 - The ANVISA Authorization of Operation is divided in a combination of fields vs. activities:

• 2.1.1 - Fields (main ones)

• A-) Products for Health (correlations)

• B-) Medicines and pharmaceutical inputs

• C-) Household cleaners

• D-) Cosmetics, hygiene products and perfumes

• 2.1.2 - Activities (main ones)

• A-) Manufacturing

• B-) Distribution

• C-) Importation

• D-) Exportation

• E-) Transportation

• 2.2 – Special Authorization of Operation (exclusive for controlled medicines);

• 2.3 – Authorization of Operation Renovation;

• 2.4 – Changes in the Authorization of Operation (such as changing the technical person in charge, etc.)

License in other Agencies:

• 3 - Fire Brigade:

• 3.1 - AVCB –notice of fire brigade inspection;

• 3.2 – Projects approval;

• 3.3 – Fire brigade certificate;

• 3.4 – Projects elaboration;

• 3.5 – Projects for the installation and suitability of liquefied petroleum gas (LPG);

• 3.6 - Technical report for inspection capacitation;

• 3.7 – Pre-inspections;

4 - CETESB:

• 4.1 – Cadri (Certificate of Environmental Interest Residues Movement);

• 4.2 - CDL – certificate of license exemption;

• 4.3 – Allocation of industrial residues;

• 4.4 – License of operation;

• 4.5 – License of prior installation;

• 4.6 – Environmental licensing;

• 4.7 – Conservation plan;

• 4.8 – Fine resource

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