Proposal accelerates registration of identical active ingredients in Brazil

The Brazilian Ministry of Agriculture, Livestock, and Supply (Mapa) launched a proposal to establish specific procedures to accelerate the registration of identical active ingredients in Brazil.

Ordinance No. 737 was published, which submits this proposal to a broad public consultation for 60 days.

The ordinance involves Mapa and the other two regulatory bodies for registering active ingredients in Brazil, Ibama (Brazilian Institute of Environment and Renewable Natural Resources) and Anvisa (Brazilian Health Regulatory Agency).

The proposal establishes the distribution of processes pending registration of equivalent technical products, premises, and formulated products of pesticides, filed with the bodies before October 7, 2021.

The proposal presented was prepared by representatives of the three bodies and sought to optimize the evaluation of products based on the same active ingredients.

The process distribution rite will consider the active ingredients that make up the products, and each distribution may have up to 20 processes of the same active ingredient, respecting the protocol date.

Another procedure to be adopted is for formulated products that have the same qualitative and quantitative composition and the same type of formulation as another product already registered, evaluated or submitted for evaluation with a complete dossier of studies.

These products may be processed separately from the joint evaluation in an even more simplified way.

″The simplification in the analysis of the products does not compromise the control exercised by the bodies that consent to the registration, as they are products with a quality-quantitative composition identical to others already registered, evaluated or submitted to an evaluation, which will serve as a reference for the registration,″ explained the general coordinator of Agrochemicals and Related Products, André Peralta.

Technically substantiated suggestions must be forwarded through the Normative Acts Monitoring System (Sisman), of the Ministry of Agriculture and Livestock Defense of the Ministry of Agriculture.

(Editing by Leonardo Gottems, reporter for AgroPages)