FEDERAL OFFICIAL GAZETTE OF BRAZIL
Published on November 3rd of 2023
Joint Ordinance SDA/MAPA – IBAMA – ANVISA No. 3, from September 29th of 2023
Establishes specific procedures for the distribution of pending registration processes for equivalent technical products, premixes and formulated pesticide products and the like, with the purposes of complying with art. No. 3 of Decree No. 10833, from October 7th of 2021.
THE SECRETARY OF AGRICULTURAL DEFENSE OF THE MINISTRY OF AGRICULTURE AND LIVESTOCK, using the powers given to him by articles No. 22 and No. 49 of the Annex I of Decree No. 11332, from January 1st of 2023, the PRESIDENT DIRECTOR OF THE NATIONAL HEALTH SURVEILLANCE AGENCY, in the use of the powers given to him by the articles 7th, item III, and 15th, item III, of Law No. 9782, from January 26th of 1999, article 12th, item V, first part, of Annex I of Decree No. 3029, of April 16th of 1999 and art. 173, VIII, first part, of ANVISA’s Internal Regulations, approved by Collegiate Board Resolution – RDC No. 585, from December 10th of 2021 and the PRESIDENT OF THE BRAZILIAN INSTITUTE OF THE ENVIRONMENT AND RENEWABLE NATURAL RESOURCES – IBAMA, in the use of the powers given to him by article No. 15th of Decree No. 11095, from June 13th of 2022, which approved the IBAMA Regimental Structure, and in view of the provisions of Law No. 7802, of July 11th of 1989, in Decree No. 4074, from January 4th of 2002, in the Decree No. 10833, from October 7th of 2021, and what appears in Processes No. 25351.921455/2022-25 (ANVISA), 21000.077337/2022-07 (MAPA), and 02001.010691/2022-99 (IBAMA), have established:
Article No. 1 – To establish, in compliance with the provisions of art. 3rd of Decree No. 10833, from October 7th of 2021, specific procedures for the distribution of processes of equivalent technical products, premixes and formulated products pending analysis for registration, filed with the federal agencies of Agriculture, Health and Environment before October 8th of 2021.
Article No. 2 – The distribution of processes of equivalent technical products will take into account the active ingredient, and the request in the first position of the analysis queue will determine the joint distribution of up to 20 processes of the same active ingredient, respecting the dates of protocol.
Article No. 3 – The distribution of the processes of premix products and formulated products will take into account the conclusion of the analysis by two of the three competent agencies, regardless of the date of protocol.
The distribution provided for in the caput does not apply to products containing active ingredients undergoing environmental revaluation.
Article No. 4 – Requests for registration of formulated products that have the same qualitative and quantitative composition and the same type of formulation as another product with a complete dossier of studies that was already registered or evaluated or submitted for evaluation may have their own processing.
1st – The first agency that completes the analysis of the application referred to in the caput will communicate to the other responsible agencies, which will be able to evaluate the product in a simplified way, as long as the product does not present, in comparison to the product with a complete dossier:
I – additional crops;
II – higher number of applications and dosage; and
III – different interval, modality and time of application.
2nd – If it is not possible to adopt the procedures in the § 1st of this article, environmental and health evaluations will be done by the competent agencies.
3rd – The applicant for registration of a formulated product referred to in the caput must provide a “Declaration of Assignment of Studies” and “Comparative Table”, as per Annexes I and II, respectively, so that their product can have its own processing in accordance with Article No. 4.
4th – The “Declaration of Assignment of Studies” referred to in § 3rd will not be needed when dealing with products from the same company.
Article No. 5 – The company holding the formulated product transferring studies and the company requesting registration must certify that the formulated product dossier indicated by the applicant is complete when regarding current legislation.
Article No. 6 – Failure to comply with the conditions established in this Joint Normative Ordinance may result in administrative, civil and criminal liability in accordance with Decree No. 4074, from January 4th of 2002, and other pertinent legislation.
Article No. 7 – This Joint Normative Ordinance is in force from November 3rd of 2023.
CARLOS GOULART
Secretary of Agricultural Defense
ANTONIO BARRA TORRES
Director-president of ANVISA
RODRIGO ANTONIO DE AGOSTINHO MENDONÇA
President of IBAMA