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Pesticide registration rejection in Brazil and ANVISA’s new technical note
May. 15, 2018
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Brazil
Pesticide registration in Brazil is evaluated by three ministries: Ministry of Agriculture (MAPA), IBAMA (environment) and ANVISA (health).Based on the survey conducted by AllierBrasil, majority of the registration processes being evaluated right now were submitted in 2011 (equivalent formulated product, FP-E) and 2012 (equivalent technical product, TP-E).
The registration process must be submitted within a period of not more than 5 days at the 3 ministries and MAPA is responsible for the approval only after the evaluations of the other two ministries. The registration process of TP-E is jointly evaluated by the ministries involved. For formulated products, different from the case mentioned, the evaluations are conducted independently by each ministry, and it is not rare for the approvals by either ANVISA or IBAMA to have a time lapse of over 6 years. That means the process is evaluated and approved by one of the two ministries (ANVISA or IBAMA), but the evaluation by the other ministry may take much longer. Still, the process of the formulated product will only be eligible for evaluation after the approval of the registration of the respective technical product.
The registration process of technical product based on equivalency, if not considered equivalent, than it will be evaluated by ANVISA, which evaluation will be focused on impurities and toxicology. This stage is called Phase II. Currently, this stage has taken up to 18 months to conclude. If the equivalence is proven, the process will then have its registration approved.
In the survey conducted by AllierBrasil the rejections of chemical pesticide registration processes by ANVISA, from January 2017 to May 2018, observed 7 rejections of equivalent technical products, which were in Phase II; 20 rejections of formulated products based on equivalency; 3 rejections of new active ingredient technical products; and 7 rejections formulated products based on new active ingredients.
Majority of the cancelled submissions was initiated between 2009 and 2011. The processes were cancelled after almost 10 years awaiting the evaluation. There are several reasons. It is important to emphasize that from 2009 to the time of evaluation, many evaluation procedures were reviewed and changed and in this way the adaptations to be filled out by the registrants were burdensome, expensive and time consuming.
Rejections of chemical pesticide registration processes by ANVISA
(January 2017 to May 2018)
Notes:
TC-E: technical product based on equivalency
FP-E: formulated product based on equivalency
New AI: new active ingredient
FP new AI: formulated product of new active ingrediente
FP: formulated product of an already registered technical product
Source: ANVISA
Author’s notes:
Some registration submissions can still have their rejections reconsidered, based on the fact companies have the possibility of appealing through the administrative and judicial resources against ANVISA’s decisions.
Recoved: rejected once, and registration was approved after registrant appeal.
However, these numbers do not represent the total number of rejected submissions, because the rejections due to IBAMA and MAPA should also be taken into consideration.
In most of the cases listed above, many of the registration petitions were benefited by judicial decisions in order for their requests to be evaluated almost immediately after the judicial decision. Nevertheless, it is innocuous to have the registration process evaluated if it does not comply with the procedures established by the three ministries. Besides the high cost of the lawsuit, where attorney fees vary between US$ 15,000 and US$ 40,000 per lawsuit, it should be taken into consideration that, proportionally, the highest number of rejections is from those that had their evaluations anticipated by the court, in comparison to other registration processes.
The technical note 01/2018 of ANVISA dated April 17 ratifies some of the reasons for the cancellation of the registration petitions:
The technical note 01/2018 of ANVISA dated April 17 ratifies some of the reasons for the cancellation of the registration petitions:
3. Anvisa will evaluate product registration only if the submission is correctly provided with all relevant documentation. Thus, any insufficiency or non-satisfactory of the technical documentation will lead to refusal of the petition ...
4. ... filed amendments, which change the initial petition of the registration request, such as request for changes and inclusions, which configure post-registration petitions, will not be accepted ...
5. ... “Clarification about refusals of registration requests due to toxicological studies conducted not in compliance with international recognized protocols”, GGTOX has informed the adoption of the rejection instrument without issuance of queries in cases, when the registration submissions are not duly provided with the required documentation.
6. The use of queries (to companies by ANVISA) is not mandatory ...
7. ... GGTOX released Service Instruction ..., in which it provides the information that registration submissions, which are not correctly provided with documentation, will be rejected without issuance of queries (to companies) by ANVISA.
8. ... issuance of another query (to companies by ANVISA) confirming the information in a previously sent query (to companies) is not possible.
Note:
GGTOX: pesticide department of ANVISA.
Considering that pesticide registration is still the main barrier to access the market in Brazil and the long period of time to obtain registrations, it is mandatory the submitted dossiers of the products to be in compliance with the legislation and they must always be updated during every change in the effective standards. Some manufacturers and laboratories with vast experience still face rejections of their petitions.
AllierBrasil is organizing the 13th Forum AllierBrasil to discuss the issues regarding the registration of pesticides, clones, market, monitoring the competition, laboratory tests, among other topics. The event will be held on May 25th in Hangzhou, China. For enrollment, send an email to allierbrasil@alllierbrasil.com.br
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