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e-PMN注册和软件定义问题 临安科达认证技术咨询服务有限公司   时间:2021-03-29   点击:1355 次
授权官员是公司中对通知中的数据负有法律责任的人。通常,这将是认证页面签字的人。主要授权官员可通过CDX向EPA提交第5节的任何文件。这包括第5节通知(PMN,SNUN,LVE,TMEA,LoREX,对LVE和LoREX的修改,生物技术,Bona Fide,NOC和支持信函)和第5节通知(修订,测试数据和通信)的支持文件。注意:只有授权官员才能提交第5节通知。


Questions about Registration and Software Definitions

有关注册和软件定义的问题


Who is a Primary AuthorizedOfficial and what can a Primary Authorized Officialsubmit?

谁是主要授权官员?主要授权官员可以提交什么?

An Authorized Official is a person in a company legallyresponsible for the data in the notice. Generally this would be the person whosigns the certification page. A Primary Authorized Official may submit anysection 5 document via CDX to EPA. This includes section 5 Notices (PMN, SNUN,LVE, TMEA, LoREX, Modifications to LVE and LoREX, Biotechnology, Bona Fide, NOCand Letters of Support) and support documents to the section 5 Notices(amendments, test data, and correspondence). Note: Only Authorized Officialsmay submit section 5 Notices.

授权官员是公司中对通知中的数据负有法律责任的人。通常,这将是认证页面签字的人。主要授权官员可通过CDXEPA提交第5任何文件。这包括第5节通知(PMNSNUNLVETMEALoREX,对LVELoREX的修改,生物技术,Bona FideNOC和支持信函)和第5节通知(修订,测试数据和通信)的支持文件。注意:只有授权官员才能提交第5节通知。

A Primary Authorized Official can also assign persons to workon their behalf (Agents/Consultants and Support persons); see below.

主要授权官员也可以指派人员代表他们工作(代理人/顾问和支持人员)见下文。


Who is a SecondaryAuthorized Official and what can a Secondary Authorized Official submit?

谁是二级授权官员,二级官员可以提交什么?

A Secondary Authorized Official is a person in a companylegally responsible for the data in the notice who will be submittinginformation in a joint submission or Letter of Support. Generally this would bethe person who signs the certification page. A Secondary Authorized Officialmay submit joint submissions or Letters of Support to any section 5 documentvia CDX to EPA. This includes section 5 Notices (PMN, SNUN, LVE, TMEA, LoREX,Modifications to LVE and LoREX, Biotechnology, and Bona Fide). Note: OnlyAuthorized Officials may submit section 5 Notices.

二级授权官员是公司中对通知中的数据负有法律责任的人员,他们将在联合提交或支持信函中提交信息。通常,这将是签署认证页面的人。二级授权官员可通过CDXEPA提交任何第5节文件的联合提交或支持信函。这包括第5节通知(PMNSNUNLVETMEALoREXLVELoREX的修改,生物技术和Bona Fide)。注意:只有授权官员才能提交第5节通知。

A Secondary Authorized Official can also assign persons towork on their behalf (Agents/Consultants and Support persons); see below.

中级授权官员也可以指派人员代表他们工作(代理人/顾问和支持人员)见下文。


Who is a Primary Agent/Consultant and what can aPrimary Agent/Consult submit?

谁是主要代理人/顾问,主要代理人/顾问会提交什么?

A Primary Agent/Consultant is a person not of the submittingcompany who wishes to create section 5 notices on behalf of the AuthorizedOfficial. These persons will also be able to submit amendments to the originalnotice and be able to submit supporting documentation (test data and othercorrespondence).

主要代理人/顾问是非提交公司的人,他希望代表授权官员创建第5节通知。这些人还可以提交原始通知的修正案,并能够提交支持文件(测试数据和其他信件)。

Note: Only Authorized Officials may submit the originalsection 5 Notices.

注意:只有授权官员才能提交原始的第5节通知。


Who is a Secondary Agent/Consultant and what can aSecondary Agent/Consult submit?

谁是二级代理/顾问,二级代理/顾问可以提交什么?

A Secondary Agent/Consultant is a person not of thesubmitting company who wishes to create joint submissions or Letters of Supporton behalf of the Secondary Authorized Official. These persons will also be ableto submit amendments to the original joint submission/Letter of Support.

二级代理/顾问是非提交公司的人,他们希望代表二级授权官员创建联合提交或支持信函。这些人还可以提交原始联合提交/支持信函的修正案。

Note: Only Authorized Officials may submit the originalsection 5 Notices.

注意:只有授权官员才能提交原始的第5节通知。

Who is a Primary Support Registrant and what can aPrimary Support Registrant submit?


谁是主要支持注册人以及主要支持注册人可以提交什么?

A Primary Support Registrant is a person designated by anAuthorized Official to edit e-PMN documents on behalf of an AuthorizedOfficial. The Support Registrant can be another person from the AuthorizedOfficial's company or can be a person from outside the company.

主要支持注册人是指由授权官员指定代表授权官员编辑e-PMN文档的人员。支持注册人可以是授权官员公司的另一个人,也可以是公司外部的人。

A Support Registrant may not submit any documents.

支持注册人不得提交任何文件。


Who is a Secondary Support Registrant and what cana Secondary Support Registrant submit?

谁是次要支持注册人以及次要支持注册人可以提交什么?

A Secondary Support Registrant is a person designated by aSecondary Authorized Official to edit joint submissions or Letter of Supportdocuments on behalf of an Authorized Official. The Support Registrant can beanother person from the Authorized Official's company or can be person fromoutside the company.

次要支持注册人是由中级授权官员指定的人员,代表授权官员编辑联合提交文件或支持信函文件。支持注册人可以是授权官员公司的另一人,也可以是公司外部的人。

A Support Registrant may not submit any documents.

支持注册人不得提交任何文件。



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