AFE current rules under RDC 860/2024: no periodic renewal

1. Key takeaways

The AFE no longer carries any periodic renewal requirement: RDC 860/2024 was published and entered into force on May 8, 2024, deleting the renewal provisions for the AFE and the AE while broadening the scope of exemptions. As long as the local health licence remains valid and the company maintains the approved conditions, the AFE stays effective. Any secondary source still stating that the AFE must be renewed periodically is outdated. When GRZAN reviews a client’s existing compliance documentation, the first task is to locate requirements of this kind that have already been deleted and to retire the corresponding internal processes before they mislead a project schedule.

2. Legal basis

• Standards for applications for operating authorization and special authorization — RDC No. 16/2014, published on April 1, 2014; Article 3 (the operating authorization is granted by activity, including import)
• Resolution amending RDC 16/2014 — RDC No. 860/2024, published and in force as of May 8, 2024; deletes the renewal provisions for operating authorization and special authorization, broadens the scope of exemptions, and allows related changes to take effect immediately [practical estimate, subject to what ANVISA publishes]
• Operating conditions for companies subject to health licensing — Decreto No. 8.077/2013, of August 14, 2013; Article 2, Article 3 and Article 4

3. Expert insights

The GRZAN view is that the statutory footing of the AFE comes from Decreto 8.077/2013, Article 2: companies engaged in production, import, distribution, storage or transport must obtain ANVISA authorization specifying the activities and product categories, while also holding the state or municipal health licence. RDC 16/2014 supplies the application standards and RDC 860/2024 is the current amendment, so the three instruments must be cited together. Citing only the 2014 instrument means missing the single most consequential change, which is precisely the one that reshapes how the document should be maintained.

The second point: no periodic renewal does not mean no maintenance. The operating authorization is granted by activity, so adding an import or storage activity still requires an amendment, and the one-address-one-licence principle established by Decreto 8.077/2013, Article 4, means that changing a warehouse forces a fresh look at what the licence actually covers. GRZAN recommends treating the AFE as a dynamic document that moves with the business, not as a certificate to be framed and hung on a wall until a problem appears.

Third, the AFE and product registration are two parallel prerequisites: the AFE governs whether the company may act, the registration governs whether the product may be sold. Both take effect upon publication in the DOU, neither can substitute for the other, and neither is optional. Starting the AFE process in parallel while the product registration is pending is the standard move for shortening the overall time to market, because the two tracks are reviewed by different logics even within the same agency.

The fourth point concerns document currency: RDC 860/2024 is a recent rule, and a large volume of secondary material in circulation still repeats the pre-amendment language. GRZAN requires clients in projects to take the latest text from ANVISA’s official legislation database as the reference, not the historical templates of service providers, however convenient those templates may look at the drafting stage.

The fifth point concerns budget. Since there is no renewal step, companies do not need to reserve periodic renewal budget or staffing for the AFE; what should be budgeted routinely is the cost and lead time of amendments. Amendments cluster around activity expansion, relocation and corporate restructuring, and in practice they occur more often than renewals ever did, which is exactly why the old mental model of a fixed renewal cycle no longer fits the way the authorization actually behaves.

4. Practical recommendations

GRZAN recommends fixing three checks into the annual compliance review: whether the activities stated on the AFE match the operations actually performed, whether the local health licence remains within its validity, and whether the registered address and warehouse addresses are still covered by the licence. Each check should leave a written record, because those records are what make an inspection conversation short rather than stressful.

Small and micro entities benefit from exemptions and simplified arrangements; before applying, confirm the applicable size tier to avoid walking the full corporate route unnecessarily. Review results should also be fed back to the compliance owner at the parent company, so that decisions at headquarters are not made on assumptions the Brazilian side has already outgrown. Where internal process documents still state that the AFE must be renewed every few years, retire them promptly, because stale documents distort both project scheduling and budget planning in ways that are hard to detect until they bite.

In addition, draw the AFE and the product registration onto a single timeline: identify which steps can run in parallel and which must wait for DOU publication. GRZAN’s experience in Brazilian projects is that the company layer, rather than the product layer, more often becomes the critical path, because the company layer involves premises, personnel and local licensing, and a delay in any one of those elements holds up the entire program regardless of how mature the technical file is.

5. Verification checklist

• □ Do the activities stated on the AFE cover the actual import, distribution and storage operations
• □ Is the local health licence valid and consistent with the AFE address
• □ Are internal process documents still using the outdated wording of periodic AFE renewal
• □ Have corporate changes and address changes been processed as AFE amendments

Regulatory information verified as of October 29, 2026

GRZAN Regulatory Team

GRZAN supports manufacturers entering the Brazilian market across the full holder and import chain: holder-structure design, AFE and operating authorization planning, importer qualification, vigilance readiness and official fee budgeting. For tailored support on Brazilian license holders, import qualifications and fee budgets, contact info@grzanglobal.com.