Does Your Company Need AFE? A Comprehensive Guide by Stone Okamont
In the world of regulated products, AFE (Autorização de Funcionamento de Empresa) is more than just a permit; it is the legal bedrock of your operation in Brazil. Think of it as the Brazilian equivalent of an FDA Establishment Registration or an EU Manufacturer/Wholesale Authorisation. Without it, your company is legally prohibited from manufacturing, distributing, or exporting.
For many international investors and managers, obtaining an AFE can feel like a regulatory labyrinth—filled with complex standards, specific pre-requisites, and timelines that can disrupt any strategic plan. But what if you could turn this mandatory hurdle into a foundation for operational excellence?
With Stone Okamont, that transformation is possible. Our mission goes beyond securing documents: we ensure your business operates with safety, compliance, and efficiency, turning the AFE process into a streamlined, accelerated path to market.
What is AFE and Who is Required to Have It?
The AFE is the official documentary proof that your company possesses the technical, sanitary, and operational conditions to handle products that impact public health.
To ANVISA (the National Health Surveillance Agency), it is the "Safety Seal" for cosmetics, sanitizers, medical devices, and pharmaceuticals. Without it, you are "invisible" to the regulator and a "sitting duck" for shutdowns, million-dollar fines, and product seizures.
Who Must Obtain an AFE?
The rule is clear: if you manufacture, import, distribute, store, repackage, or sell a regulated product—or if you are the legal representative for it in the supply chain—you need authorization.
- Manufacturers: Regardless of size, any facility producing goods under sanitary surveillance must hold a valid AFE.
- Importers: Companies importing health-regulated goods must be authorized. The absence of an active AFE blocks customs clearance, leading to rejections or cargo seizure.
- Distributors & Warehouses: Any facility storing or distributing products for commercial purposes, including third-party logistics (3PL), is part of the sanitary responsibility chain.
- E-commerce with Own Inventory: Selling online does not exempt you from health laws. If you store and ship products, you are a physical establishment subject to AFE regulation.
The Stone Okamont Pathway: From Concept to Issuance
Obtaining an AFE is not a single step, but a structured process. Timing is everything:
- Phase 1: Facility & Structural Analysis (Ensuring the building meets Brazilian codes).
- Phase 2: Documentary Analysis (Drafting technical dossiers).
- Phase 3: Sanitary License Application (Local municipal/state level approval).
- Phase 4: Federal AFE Submission (Final application with ANVISA).
The Pitfalls That Drain Your Profit
Many companies fall into traps that are easily avoidable with Stone Okamont’s guidance:
- Premature Construction: Starting renovations before the technical project is approved.
- Underestimating Requirements: Failing to meet specific RDCs (Board Resolutions).
- Neglecting Self-Control: Ignoring essential quality programs. We integrate these manuals from Day 1.
Post-AFE: Compliance Doesn’t End with the License
Securing your AFE is a milestone, but maintenance is a journey. It requires:
- Periodic renewals and updates.
- Impeccable maintenance of quality programs.
- Continuous readiness for surprise audits.
With Stone Okamont, you are not alone after the certificate is issued. We offer Ongoing Regulatory Management, ensuring your company remains compliant and free from "unpleasant surprises."
Secure Your AFE with Expert Strategic Support
The journey to obtain and maintain an AFE can be complex, but with the right strategic partner, it becomes an investment in quality and market credibility.
Stone Okamont acts as an extension of your team. We navigate ANVISA’s complex regulations so you can focus on your core business: producing excellence and growing your market share.
Is your company ready to secure its AFE with speed and safety? Contact Stone Okamont today. Our specialists are ready to lead your process from start to finish.