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For pharmacies, distributors and regulated companies
Pharmaceutical and Health Regulatory Law
Defense against health-regulatory violation notices, proceedings before ANVISA and local health surveillance authorities, and regulatory compliance for companies in the sector.
The problem
A health-regulatory violation notice can affect the whole operation
Violation notices (autos de infração sanitária), closures, seizures and proceedings to revoke authorizations can paralyze a pharmacy or distributor. Health-regulatory violations and their penalties are set out in Law No. 6,437/1977, and each level of health surveillance has its own procedures and deadlines.
Our work combines defense in the health-regulatory proceeding with a review of the routines that gave rise to the notice, to reduce the risk of recurrence and of consequences for other programs and accreditations.
Situations we handle
Situations we handle
- Health-regulatory violation notices and administrative defenses
- Closures, seizures and destruction of products
- Company Operating Authorization (Autorização de Funcionamento, AFE) and licenses
- Proceedings before ANVISA and state and municipal health surveillance
- Review of regulatory compliance routines
- Consequences of the notice for accreditations and public programs
How we work
Stages of our work
Step 1
Analysis of the notice
Legal basis, description of the conduct and proposed penalty.
Step 2
Timely defense
Written defense with documents and proof of regularity.
Step 3
Appeals
Administrative instances and, if appropriate, court action.
Step 4
Prevention
Adjustment of routines to reduce the risk of new notices.
Frequently asked questions
Common questions
What is the deadline to respond to a health-regulatory violation notice?
The deadline appears in the notice itself and in the legislation applicable to the level of government that issued it. It is important to check it as soon as the notice is received.
Can a violation notice affect participation in the Popular Pharmacy Program?
It can, depending on the nature of the violation and the Program’s rules. That is why the defense must consider the consequences for other accreditations.
For general information only. Each case depends on a review of the documents and the stage of the proceeding.
Related areas
Regulatory
Regulatory
Contact
Discuss your case with the firm
Send a brief description of the matter and, if applicable, the case or proceeding number.