On December 23, 2024, the Brazilian Health Regulatory Agency (ANVISA) published Public Consultation No. 1.303, which aims to draw up a regulatory act with guidelines for managing health risks and monitoring companies’ compliance.
The proposal seeks the creation of a Collegiate Board Resolution (RDC) to regulate the granting or renewal of Good Manufacturing Practice Certificates (CBPF) and Good Distribution and/or Storage Practice (CBPD/A) Certificates. These certificates are applicable to manufacturers of active pharmaceutical ingredients (APIs), medicines, cannabis-based products for medicinal purposes, biological and health products.
The Good Manufacturing Practices Certificate (CBPF) is a document issued by ANVISA proving that the establishment complies with the technical requirements of Good Manufacturing Practices required by current legislation for the marketing of its products. The Good Distribution and/or Storage Practices Certificate (CBPD/A) attests that the company follows the technical standards related to Good Distribution and Storage Practices or Good Storage Practices, also established by legislation.
The proposed resolution establishes several requirements for health risk management, such as i) class and risk classification of the product; ii) complexity and criticality of the establishment; and iii) storage and transportation conditions, among others, which will be analyzed for both the granting and renewal of certificates. These certificates will only be granted or renewed upon presentation of an analysis of the inspection and risk analysis report, as per Article 4. In addition, compliance with these requirements will be subject to continuous monitoring, allowing ANVISA to initiate investigations or cancel certificates if necessary.
The deadline for sending comments and suggestions is 60 days, starting seven days after the publication of the public consultation in the Federal Official Gazette. Contributions must be made using an electronic form available on ANVISA’s website.
With this initiative, ANVISA seeks to ensure that establishments satisfy the required quality and safety standards, promoting greater confidence in the products made available to the market.