2006 年 12 月发布的关于按等效性登记农药的联邦法令 5981 / 2006 导致此类产品的登记成本显着降低。
Nonetheless, the process of registering “me-too” products has not become as streamlined as had been anticipated. On the contrary, with the new regulatory rules introduced by this decree and the experience gained both by the registration authorities and by registrant companies’ representatives, the process became much more complex and detailed, demanding that registrants and manufacturers produce extensive documentation to prepare and to elaborate on the required reports.
这导致准备注册包的时间更长，特别是对于技术产品。
三步法
Federal Decree 5981 / 2006 provides for registrations by equivalency of technical products in three phases, with the following requirements:
第一阶段： 5批次分析、理化试验。
第二阶段： 急性毒性试验，致突变性。
第三阶段： 亚慢性和慢性毒性及生态毒理学试验。
因此，注册公司可以根据 5 批次和物理化学研究的结果，仅考虑化学等效性（第一阶段）来申请注册。
如果在第一阶段无法证明等效性，注册机构可能会要求进行额外的急性毒性研究，包括但不限于第二阶段所需的诱变试验（艾姆斯试验和微核试验）。
如果急性毒性试验不足以证明 II 期产品的等效性，当局可能会要求进行额外的试验，包括亚慢性和慢性试验（III 期），从而导致成本显着增加，并远远超过之前的估计成本实施等效登记法令。
在这种情况下，应重新考虑继续申请相关注册的可行性。
更多并发症
此外，在某些情况下，根据活性成分和制剂的类型，需要提交功效和残留试验。
For the purpose of registrations in each individual state, no amendment has been made to the legislation with respect to Me-Too product registration. Individual states are free to enact their own legislation on this matter according to the Brazilian constitution. In fact, as an example, the state of Parana — one of the most important agricultural producers in Brazil — requires two efficacy trials for each recommended rate and biological target to be performed by diverse official entities at different locations, as well as one residue trial.
观看费用
今天，技术产品及其配方和成分的注册成本估计约为 $170,000 美元。该估算是实验室、田间功效和两种作物、两个生物目标和每个目标的两个费率的残留测试的平均成本，此外还有卫生和环境部对第二阶段的政府收费。估计数额是由具有国际良好实验室规范 (GLP) 认证的顶级实验室和在巴西运营的实地研究实体收取的费用。
还应考虑额外费用，包括但不限于：文件翻译、公证、领事、差旅费和样品进口税。由于 5 批次分析，可能会发现变化取决于测试的作物以及活性成分。
进一步规定
此外，成本增加将在 2008 年 5 月和 6 月之后产生，因为新法规要求所有官方实地研究机构的认证，加上田间残留试验的良好田间规范，以及进行试验的实体的相应官方认证。 2008年6月起，实验室残留试验全部按照GLP进行。
多家公司广泛采用在不同实体承包实验室测试的程序，以帮助他们降低成本；但是，他们的结果可能会有所不同，这可能会使某些已订购的测试无效，从而造成进一步的延误。
In addition, due to the tight demand for studies with pesticides, many laboratories work at maximum capacity to perform the tests — particularly the 5-batch analysis — which may require a lead time of up to 24 months in certain cases, such as for physical-chemical and mutagenicity tests. Thus, it is quite common to have an incomplete test package, causing delays in the submittal of the registration application.
上市速度
In spite of the complexity of the Me-Too product registration process in Brazil, upon the determination of the High Authority of the Brazilian government, registrations have been expedited, and this has yielded a record number of 202 approved registrations last year — 54 technical products and 148 formulations.
今天，对注册技术产品的批准提前期的非官方估计是从申请之日起大约八个月。
此参数与技术产品相关，因为在相应配方产品的审查之前必须进行注册批准。
高风险
Thus, for the near future, a new outlook exists for Me-Too products in the Brazilian market — which is the most attractive market, worldwide. Total sales in 2007 reached the historical figure of US $5.31 billion at the distributor level. This means almost 60% growth compared to 2003, when sales were $3.2 billion.
尽管它是进入巨大的巴西作物保护市场的最重要工具，但产品注册本身并不能保证成功。最近的案例表明，一些刚进入该市场的国际公司在获得注册批准后的第一年就遭受了重大损失，有时甚至在紧接其后的几年中也遭受了损失。
选择在巴西开展业务时，分销、营销、信贷和付款条件以及竞争都是战略计划中要考虑的关键项目，以确保高性能和可观的利润。