Anvisa approves new resolution regarding simplified marketing authorization in Brazil

On December 19, 2024, the Collegiate Board of the Brazilian Health Surveillance Agency (Anvisa) approved a resolution (Resolution No. 954/2024) providing for procedures for new streamlined form of marketing authorization (Simplified Marketing Authorization), as well as requests to change and renew authorizations for drugs and biological products. For the most part, the new rules are set to take effect on January 21, 2025.

Simplified Marketing Authorization

Simplified Marketing Authorization is applicable to drugs and biological products:

• Already held by a company within the same economic group as the applicant; or
• Resulting from Productive Development Partnerships (PDP) or via a technology transfer process (Prior Marketing Authorization).

As per the Brazilian Drug Market Regulation Chamber’s (CMED) Notice No. 5/2015, ‘companies within the same economic group’ refers to companies under common control, together with any other companies in which they hold at least 20% of the share capital or voting capital.

Requirements

Companies must comply with the following requirements to apply for the Simplified Marketing Authorization:

• Hold a drug or biological product with a valid marketing authorization;
• Possess an approved marketing authorization renewal request for the drug or biological product (as applicable);
• The application must refer to a drug that Anvisa has classified as a ‘reference drug’ or as a ‘therapeutically equivalent drug’ (as applicable); and
• The application must refer to a drug that Anvisa has classified as a new or innovative, generic, similar, specific, dynamized, herbal, radiopharmaceutical or biological product (as applicable).

Simplified Marketing Authorization applications must be submitted electronically with the specific information required for the Prior Marketing Authorization – except for information on the drug or biological product’s name, labeling and packaging. Such applications must also be accompanied by specific documents, including Anvisa’s Good Manufacturing Practices Certificate (CBPF) and Operating Permit (AFE).

Cancelation and changes to Simplified Marketing Authorization

A request to cancel a Simplified Marketing Authorization can be filed in the following situations:

• By a government authority that holds the Simplified Marketing Authorization within the scope of a PDP;
• By the holder of a Simplified Marketing Authorization, once a technology transfer process to produce strategic drugs for the Ministry of Health has concluded;
• By the holder of a Simplified Marketing Authorization in cases where a renewal request has been denied due to efficacy, safety, and quality issues.

The new resolution also provides for specific situations in which changes can be made to the Simplified Marketing Authorization regardless of submitting the same changes to the Prior Marketing Authorization. However, in the event of changes to the Prior Marketing Authorization, the Simplified Marketing Authorization holder must request the same changes within 30 days.

Transitional rules

Anvisa may require Simplified Marketing Authorization applicants to provide a complete and updated dossier of the relevant Prior Marketing Authorization within 60 days, with the risk of the application being canceled in the event of non-compliance. This transitional rule will come into effect on April 21, 2025.

Furthermore, note that the marketing authorizations for drugs granted as per the terms of Resolution No. 31/2014 and that are not contemplated in Resolution No. 954/2024 remain valid.

For more information on this topic, please contact Mattos Filho’s Life Sciences & Healthcare practice area.

*With the collaboration of Marina Castro de Amorim