ANVISA publishes resolution for marketing authorization applications, post-approval changes, and simplified renewal procedures

On December 23, 2024, the Brazilian Health Regulatory Agency (“ANVISA”) published RDC No. 954/2024, which establishes the criteria for marketing authorizations (“MA”), post-approval changes, and simplified renewal procedures for generic, similar, specific, dynamized, herbal, radiopharmaceutical, and biological products. 

The resolution applies to MAs, post-approval changes, and renewal applications relating to medicines linked to a primary or secondary application of a medicine already registered by a company integrating the same economic group.

For a medicine to be eligible for the simplified procedure, the primary application must:

• Refer to a medicine currently under an MA, whether it is a new or innovative medicine, generic, similar, specific, dynamized, phytotherapic, radiopharmaceutical, or biological product;
• Refer to a medicine that has been authorized or renewed in compliance with the applicable regulation;
• Not have had a denied renewal application; and
• Refer to a medicine that is featured on ANVISA’s list of reference medicines, or to a medicine that is therapeutically equivalent to the reference medicine chosen by ANVISA at the time the bioequivalence and pharmaceutical equivalence studies were carried out – provided that the reference medicine has not been removed from the reference list due to quality, efficacy, and safety issues.

The MA simplified procedure must be linked to the MA primary application procedure, with no discrepancies between the MAs, except in aspects such as labeling and the medicine’s name.

In the case of a medicine that is subject to a manufacturing stage in Brazil, the applicant company must have an Operating Permit (“AFE”) for the manufacturing activity and, in the case of a medicine that is subject to either a manufacturing or packaging stage abroad, an AFE for the import activity is also required.

The simplified application for a post-approval change can be used in the following cases:

• MA withdrawal;  
• Correction of data in the database;
• New indication;
• Package insert information under immediate implementation;
• Permanent discontinuation of manufacture or import;
• Temporary discontinuation of manufacture or import;
• Reactivation of manufacture or import;
• Trade name change;
• Publication rectification;
• Labeling change; and
• MA transfer of ownership.

Additionally, the delinking of the MA granted through the simplified procedure from the primary MA can occur in the following cases, upon publication of the delinking approval in the Brazilian Federal Official Gazette:

• Within the scope of a Productive Development Partnership (“PDP”), when requested by the public partner holding the MA under the simplified procedure;
• After the process of technology transfer of strategic medicines to the Ministry of Health, when requested by the MA holder, granted under the simplified procedure. In this case, the company must prove that the technology has been absorbed, which is not applicable in cases of mere licensing or authorization to use the MA dossier; or
• When the renewal of the primary MA is denied for reasons that do not involve efficacy, safety, and quality failures, when requested by the MA holder via simplified procedure.

The resolution comes into force on January 21, 2025. The possibility for ANVISA to request the complete or partial dossier comes into force on April 21, 2025.

Demarest’s Life Sciences and Healthcare team is available to provide any further clarifications that may be necessary.