Brazil: New Subject Code for Microbiological Product (Simplified Registration Route)

ARQon
Oct 4, 2023
1 min read

Previously on 10 April 2023, Anvisa regulated a simplified registration route for microbiological products under Joint Ordinance SDA/MAPA – IBAMA – ANVISA No.1 of April 10, 2023. The establishment applies to microbiological products used as pesticides, defoliants, desiccants, stimulants, or growth inhibitors with qualitative and quantitative composition and isolated microorganisms equivalent to reference products for which the analysis of potential environmental hazard, potential human health hazard, and agronomic efficiency has been completed.

In order to enhance efficiency and reduce processing time, Anvisa created a new subject code for microorganism product registration that is listed under the simplified registration route, which is 5141 – Microbiological Product – simplified registration route. Anvisa will separate the registration request based on the subject code, even if no technical analysis is required for the products.

Interested sponsors may submit the registration or re-evaluation registration request of the microbiological products to each of the responsible authorities, Ministry of Agriculture and Livestock, Anvisa, and Ibama, within 5 working days from the first filing. However, the simplified registration application of the biological products must be evaluated only by the Ministry of Agriculture and Livestock (MAPA).

Source: National Health Surveillance Agency (Anvisa)