Project approvals, health licenses and permits, operating authorizations and technical responsibility for operations subject to health surveillance.
From a health perspective, an operation's compliance depends on consistency between the activity carried out, the physical facilities, the technical managers and the requirements of the competent agencies.
Health approval
Design
The physical facilities approved by the health authorities must faithfully reflect the reality of the operation, whether new or already existing. For initial licensing or for changes, the company must obtain approval of the corresponding architectural design.
Regulated operation
Health License / AFE
Health license and permit, as well as the Operating Authorization, reflecting the company's actual situation.
Technical responsibility
Professional Council
Activity in good standing with the relevant professional council, with a duly qualified professional as technical manager, matching the activity carried out.
What makes this subject singular is precisely that it does not separate the facility, the authorization and the technical manager.
Layer 1
The physical facilities approved by the health authorities must faithfully reflect the reality of the operation, whether new or already existing. For initial licensing or for changes, the company must obtain approval of the corresponding architectural design.
Layer 2
Health license and permit, as well as the Operating Authorization, reflecting the company's actual situation.
Layer 3
Activity in good standing with the relevant professional council, with a duly qualified professional as technical manager, matching the activity carried out.
Layer 4
The physical facilities approved by the health authorities must faithfully reflect the reality of the operation, whether new or already existing. For initial licensing or for changes, the company must obtain approval of the corresponding architectural design.
Layer 5
Health license and permit, as well as the Operating Authorization, reflecting the company's actual situation.
In operations subject to health surveillance, the risk lies both in obtaining the license and in the technical adequacy of the facility, the activity and the professional responsibility required.
How Unity works
Unity conducts project approvals, health licenses, operating authorizations and technical responsibility registrations, connecting the facility, the activity and the regulatory requirement.
Health regulatory execution for approvals, licenses and technical responsibilities of operations subject to health surveillance, ANVISA and professional councils.
Formal points that must be tied together
Health licensing handled well reduces friction with inspections and improves the alignment between what the company operates and what it formalizes.
Each step is carried out with technical and documentary rigor to ensure compliance and predictability.
Survey of activities, facilities and technical responsibilities to identify the applicable requirements of municipal and state health surveillance, ANVISA and professional councils, mapping gaps and priorities.
Preparation of the full facility design with the technical detail required by the health authority, organization of technical responsibility registrations and of the other documents needed for the process.
Formal submission to the competent Health Surveillance Authority or to ANVISA, with follow-up of the review, support during inspections and technical dialogue with the officer handling the licensing.
Follow-up through to issuance of the health license, the Company Operating Authorization (AFE) or the formal act that brings the operation into compliance with the competent agency and enables the activity to run.
Acronyms and regulatory terms that appear in this service, explained plainly.
AFE
Autorização de Funcionamento de Empresa (Company Operating Authorization). Issued by ANVISA, it authorizes the operation of companies subject to federal health regulation, such as manufacturers, distributors and importers of medicines, cosmetics, sanitizing products and related goods.
Health licensing handled well reduces friction with inspections and improves the alignment between what the company operates and what it formalizes.